Validation Engineer II - Irvine, CA

Provide technical expertise and guidance for the preparation and execution of validation protocols and reports. Review and troubleshoot anomalies, deviations, etc. Resolves and consults on applicable validation compliance and manufacturing process issues. Mentor and leads projects. Provide technical reviews of protocols. Contribute at the validation project team level for validation activities.

https://www.indeed.com/viewjob?t=validation+engineer+ii&jk=c1032a22948a00e2&_ga=2.54114408.1395148856.1545000919-2077807285.1533320279

Computer System Validation - Morrisville, PA

Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, and other applicable regulations or procedures. Develop and manage project documentation for SDLC & COTS requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases.

https://www.indeed.com/viewjob?t=computer+system+validation&jk=2caf07db91cfb007&_ga=2.175767522.1395148856.1545000919-2077807285.1533320279

Sr. Biostatistician - Alapocas, DE

Interact with members of the multidisciplinary project teams to establish project timelines.Provide statistical input to study protocols. Write statistical analysis plans.Monitor internal and CRO project activities including timelines, deliverables and availability of resources. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.

https://www.indeed.com/viewjob?t=sr+biostatistician&jk=74cfc33729eaf688&_ga=2.209321810.1395148856.1545000919-2077807285.1533320279

Computer System Validation - Morrisville, PA

Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, and other applicable regulations or procedures.Develop and manage project documentation for SDLC & COTS requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases.

https://www.indeed.com/viewjob?t=computer+system+validation&jk=2caf07db91cfb007&_ga=2.7057650.1395148856.1545000919-2077807285.1533320279

Sr. Validation Lead, DI - San Mateo, CA

Computer System Validation processes expert.Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

https://www.indeed.com/viewjob?t=sr+validation+lead+di&jk=36529ff94862bef4&_ga=2.246010052.1395148856.1545000919-2077807285.1533320279

Product Development-Validation - Draper, UT

Participating in Internal audits, QMS audit, customer audit and reporting the audit findings to management. Identifying Gaps and Coordinate with stake holders for CAPA preparation and implementationQualification: Ensuring all jigs and fixtures, process parameters are qualifiedHandling Corrective and Preventive Actions, Customer Complaints, and responsible for Defect-free Product deliveries to the Customer.Prepare deliverables and track each activity till closure

https://www.indeed.com/viewjob?t=product+development+validation&jk=f91783282452586b&_ga=2.221810904.1395148856.1545000919-2077807285.1533320279

Product Development-Validation - Draper, UT

Participating in Internal audits, QMS audit, customer audit and reporting the audit findings to management. Identifying Gaps and Coordinate with stake holders for CAPA preparation and implementationQualification: Ensuring all jigs and fixtures, process parameters are qualifiedHandling Corrective and Preventive Actions, Customer Complaints, and responsible for Defect-free Product deliveries to the Customer.Prepare deliverables and track each activity till closureWork closely with Program manager and update status on daily basisWrite or review procedures and related documents

https://www.indeed.com/viewjob?t=product+development+validation&jk=f91783282452586b&_ga=2.11702388.1395148856.1545000919-2077807285.1533320279

LIMS Consultant - Warsaw, IN

Candidate should have strong knowledge on Environment Monitoring module in LabWare Strong in LabWare LIMS Basic development, Pharma Validation, GXP Knowledge and experience.

https://www.indeed.com/viewjob?t=lims+consultant&jk=25340d9e55caf39d&_ga=2.6313074.1395148856.1545000919-2077807285.1533320279

Business Professional Project Manager - Cambridge, MA

This section focuses on the main purpose of the job in one to four sentences.Sr. Program Managers provide business and technical leadership for major, high- complexity programs (e.g., Top Projects) within the Franchise, leading program teams through the identification, justification, planning, prioritization, initiation, development and implementation processes.Sr. Program managers will lead their teams in financial analysis including market research, cash flow, capital, and program positioning.

https://www.indeed.com/viewjob?t=business+professional+project+manager&jk=ee6e44fbdff08050&_ga=2.169056353.1395148856.1545000919-2077807285.1533320279

Senior Regulatory Labeling Specialist - Boston, MA.

Create, revise and maintain Company Core Data Sheets (CCDS) for products. Develop labeling strategies and Target Label Profiles. Keep up-to-date on emerging clinical and other data, product safety, changes in manufacturing, and completion of post-marketing commitments and requirements for products that may trigger changes to the CCDS and regional or local labeling.

https://www.indeed.com/viewjob?t=senior+regulatory+labeling+specialist&jk=f68b6d02db4238bb&_ga=2.15383030.1395148856.1545000919-2077807285.1533320279

Pharmacovigilance Systems Analyst - Bridgewater, NJ - KatalystHLS.com

Lead complex Global system and data investigations, supporting end-user inquiry and/or Global Pharmacovigilance requirements. Drive PV business requirements in collaboration with IT, PV, Regulatory, other stakeholders for application configuration requirements, designs and debugging for new products, new licenses , studies, reporting rules, E2B profiles , code list changes in console, enhancements, MedDRA up versioning , system upgrades, workflow functionality, and validations. Oversee user acceptance testing for PV Systems projects and activities.

https://www.indeed.com/viewjob?t=pharmacovigilance+systems+analyst&jk=34bcdf8adce7abf1&_ga=2.15383030.1395148856.1545000919-2077807285.1533320279

Regulatory Affairs Specialist, Medical Devices - Fort Worth, TX.

performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities. Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.

https://www.indeed.com/viewjob?t=regulatory+affairs+specialist+medical+devices&jk=49ee917eef7a931a&_ga=2.15383030.1395148856.1545000919-2077807285.1533320279

Regulatory Affairs Labeling Lead - San Francisco, CA.

Manage the preparation and maintenance of core and US labeling (Development Core Safety Information [DCSI], Company Core Data Sheet [CCDS], Target Product Label [TPL], and US Prescribing Information [USPI]) for assigned products, including pre-approval and post-approval activities; Represent RA Global Labeling cross-functionally. Support Core Label Working Group (CLWG), TPL, and USPI team meetings.

https://www.indeed.com/viewjob?t=regulatory+affairs+labeling+lead&jk=e93800862d9a5bc7&_ga=2.247157956.1395148856.1545000919-2077807285.1533320279

Validation Lead, Pharma - Bridgewater, NJ.

Provide principle support in developing and implementing the site validation program and qualification for production systems, and revalidation strategies on time, on budget and quality to ensure that programs are compliant with inspection agencies requirements and related SOPs.

https://www.indeed.com/viewjob?t=validation+lead+pharma&jk=3234028461f89b87&_ga=2.207789266.1395148856.1545000919-2077807285.1533320279

Post-Market / Sustaining Quality Engineer - Exton, PA.

Post-Market Quality Engineer (QE) will provide technical quality leadership and support for client\'s Support transition of product licenses between Client locations and implementation of new MDR/IVDR regulations. Perform batch record review for Contract Manufacturing Organization (CMO) manufactured medical devices and sWFI globally

https://www.indeed.com/viewjob?t=post+market+sustaining+quality+engineer&jk=e92454dab5bb5435&_ga=2.241406146.1395148856.1545000919-2077807285.1533320279

Quality Engineer - Raynham, MA

Must possess a clear understanding of theoretical and practical fundamentals and experimental engineering techniques. Good written and oral communication skills. Computer literate.Ability to use broad knowledge of regulatory, technical, and business requirements to effectively lead and manage improvement projects for Quality Systems for Client.Ability to apply project management skills to measure and improve performance in areas of responsibility.Thorough knowledge of CAPA and NCR.

https://www.indeed.com/viewjob?t=quality+engineer&jk=9a7daa0e28f3c90c&_ga=2.48516582.1106318309.1544823710-2077807285.1533320279

Quality Management System Specialist IV - Lexington, MA

The Company Consultant Procedural Document Facilitator/Quality Management System Specialist will be responsible for leading and executing activities related to procedural document development and training within R&D QA & Compliance, R&D as a whole, with touch points across Company.

https://www.indeed.com/viewjob?t=quality+management+system+specialist+iv&jk=bce84d5eb8f526ff&_ga=2.207498323.1106318309.1544823710-2077807285.1533320279

Senior Scientist Patient Safety - Rockville, MD

Working with the Processes and Partnership (P&P) leads in Processes and Partnership Group in Delivery and Enablement, GRAPSQA, taking responsibility for the management of assigned client- projects, processes and partnerships including implementation, communication, compliance, performance and inspection readiness. Accountable to develop relationships across GRAPSQA and other relevant areas of to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.

https://www.indeed.com/viewjob?t=senior+scientist+patient+safety&jk=54fb94f396548772&_ga=2.36513248.1106318309.1544823710-2077807285.1533320279

Regulatory Affairs Specialist IV - Cambridge, MA

Overview: The primary responsibility of this individual is to provide independent regulatory guidance to new product development and Value Stream teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches including defining data and information needed for regulatory approvals in conjunction with cross-functional business partners. Adheres to environmental policy, procedures, and supports department environmental objectives.

https://www.indeed.com/viewjob?t=regulatory+affairs+specialist+iv&jk=23ea27bdd4cfe0bf&_ga=2.240452931.1106318309.1544823710-2077807285.1533320279

Computer Systems Validation Specialist - Boston, MA

Provide development coaching to IT, IT Validation and Business for all CSV implementation across R&D and Commercial.Review the developed CSV deliverables to ensure adherence with Quality requirements.Review project plans for IT systems, identify issues and provide hands on support to Project Managers on Quality CSV requirements.Provide report on issues/bottle necks to Quality Lead.

https://www.indeed.com/viewjob?t=computer+systems+validation+specialist&jk=7b7feaa864dba6a6&_ga=2.234608477.251166156.1544469794-2077807285.1533320279

Senior Process Validation Engineer - Los Angeles, CA

We are seeking a highly motivated individual to join us as a Senior Process Validation Engineer. You will work with the Engineering and Manufacturing teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Sr. Manager, Engineering.

https://www.indeed.com/viewjob?t=senior+process+validation+engineer&jk=3d5c68cdf8d31631&_ga=2.73327059.1728769241.1544447154-1142980912.1542725334

Clinical Data Manager - Boston, MA

Responsible for vendor oversight activities across global development programs.Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Client for all data related deliverables, especially in support of key decision points and regulatory submissions.Contributes influential leadership in collaboration with other Client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.

https://www.indeed.com/viewjob?t=clinical+data+manager&jk=d2a19ff8ab5ff7e1&_ga=2.43820901.1728769241.1544447154-1142980912.1542725334

Senior Process Engineer I , Downstream - Lexington, MA

As a key member of CMSL (Commercial Manufacturing Support Laboratory) team, this individual will be responsible for providing technical and scientific leadership to support downstream processes of commercial productions.The position emphasizes hands-on, lab-based activities to design and execute studies to support process investigations/troubleshooting, process continuous improvement, tech transfer, and life-cycle management.

https://www.indeed.com/viewjob?t=senior+process+engineer+i+downstream&jk=0695d6e3f3708243&_ga=2.269005362.251166156.1544469794-2077807285.1533320279

Quality Systems Specialist III - Boston, MA

Provide continuous improvement through business analysis for systems in use supporting the QMS for O&BSupport data analytics and innovation function for existing systems and projectsResponsible for support and system administration of quality management systems and processes, to support GXP operations at the Takeda Boston (TBOS) site for the Oncology & Biologics organization, and its applicable alliance partners and suppliers.

https://www.indeed.com/viewjob?t=quality+systems+specialist+iii&jk=79b9ea417d1fb982&_ga=2.237557571.251166156.1544469794-2077807285.1533320279

Biostatistician - Irvine, CA

Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios.Perform sample size calculations and write statistical methodology sections for inclusion in study protocols.Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions.

https://www.indeed.com/viewjob?t=biostatistician&jk=7c8a9cb29b28bbe6&_ga=2.24362617.251166156.1544469794-2077807285.1533320279

Junior Project Manager, Regulatory & Quality - Chicago, IL - Indeed.com

Support and execute on all vendor management activities, building/maintaining external relationships and ensuring alignment with business and regulatory strategies.Provide operational support in collaboration with internal, external and cross-functional stakeholders as needed.Support the development and implementation of new or modified policies, processes and procedures.

https://www.indeed.com/viewjob?t=junior+project+manager+regulatory+quality&jk=77f8ef29dfbe6d94&_ga=2.33207293.251166156.1544469794-2077807285.1533320279

Global Commercial Contract Analyst - Boston, MA

The Global Commercial Contract Analyst will manage critical Shire Commercial data management activities across all franchises and regions. The analyst will assist the Global Commercial Data Management team with US, International, and all Franchise commercial data acquisition, governance and management.

https://www.indeed.com/viewjob?t=global+commercial+contract+analyst&jk=52381c7a7a6c7a0f&_ga=2.36839139.251166156.1544469794-2077807285.1533320279

Clinical Trial Management Specialist - Philadelphia, PA.

Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.

https://www.indeed.com/viewjob?t=clinical+trial+management+specialist&jk=55e0df1f86de6f8d&_ga=2.87464216.1878940423.1544377302-2077807285.1533320279

Regulatory Submission Writer - Boston, MA.

Supports External Manufacturing Department in regulatory filing section authoring for vaccine drug substance, drug product and diluent product production. May also review sections and perform data verification to source information. Coordination and preparation of technical and summary reports to support regulatory submissions. Author and review of drug substance, drug product, and diluent process qualification and production filing sections.

https://www.indeed.com/viewjob?t=regulatory+submission+writer&jk=3dc39782a6996688&_ga=2.92052890.1878940423.1544377302-2077807285.1533320279

R&D Clinical Development Project Manager - Pleasanton, CA.

Project/Program Manager (PM) is accountable for leading day-to-day operations of one or more clinical studies/programs, ensuring efficient delivery of clinical trials in a matrix environment. This activity is typically coordinated in conjunction with one or more CROs. This position will report to either the Associate Director/Director in Clinical Operations or Head of Clinical Development. Project management in areas outside of therapeutic clinical trials DOES NOT count as relevant experience for this role.

https://www.indeed.com/viewjob?t=rd+clinical+development+project+manager&jk=cefdf3474e9b9147&_ga=2.44474020.1878940423.1544377302-2077807285.1533320279

Junior Project Manager, Regulatory & Quality - Chicago, IL.

Support and execute on all vendor management activities, building/maintaining external relationships and ensuring alignment with business and regulatory strategies. Provide operational support in collaboration with internal, external and cross-functional stakeholders as needed. Support the development and implementation of new or modified policies, processes and procedures. Support the execution and management of key strategic initiatives, as needed.

https://www.indeed.com/viewjob?t=junior+project+manager+regulatory+quality&jk=77f8ef29dfbe6d94&_ga=2.220505754.300148692.1544102437-1142980912.1542725334

Clinical Data Manager - Boston, MA

Coordinates and participates in the development and design of questionnaires used to conduct patient and physician surveys as well as case report forms (CRFs/eCRFs) used for medical chart abstraction and research data collected by investigative sites.

https://www.indeed.com/viewjob?t=clinical+data+manager&jk=6f55a9cc45819850&_ga=2.64654253.300148692.1544102437-1142980912.1542725334

Regulatory Junior Project Manager - Lake Forest, IL

Support and execute on all vendor management activities, bilding/maintaining external relationships and ensuring alignment with business and regulatory strategies. Provide operational support in collaboration with internal, external and cross-functional stakeholders as needed. Support the development and implementation of new or modified policies, processes and procedures. Support the execution and management of key strategic initiatives, as needed.

https://www.indeed.com/viewjob?t=regulatory+junior+project+manager&jk=1556b0b455e0ffc8&_ga=2.157593144.300148692.1544102437-1142980912.1542725334

Senior Global Regulatory Compliance and Operations Manager - Boston, MA.

Reporting into the Global Regulatory Compliance, Operations, and Labeling Leader, the Sr Manager will support the configuration and maintenance of the Enterprise Document Management System for regulated documentation to ensure regulatory compliance worldwide. In collaboration with cross-functional teams, the incumbent will also assist in the compilation and quality checks of compliant regulated documentation for dispatch to global partners and health authorities. The ideal candidate will also be adept in managing project submission timelines, schedules and regulatory submission processes.

https://www.indeed.com/viewjob?t=senior+global+regulatory+compliance+and+operations+manager&jk=1513e8c321044840&_ga=2.33967009.1462213634.1544051968-1408033885.1530798869

Regulatory Operation Specialist - Princeton, NJ.

Responsible for the Document management activities, Operations related to quality and regulatory activities, Configuration activities, Quality Checks activities, IND work, implementation of an EDMF, Extensive Regulatory Compliance experience, Management level experience of a project, using Veeva Vault but not mandatory.

https://www.indeed.com/viewjob?t=regulatory+operation+specialist&jk=2622527bc23d1fd2&_ga=2.37695264.1646275761.1543763749-1408033885.1530798869

Quality Assurance Specialist III - Raritan, NJ.

Responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition. Provides guidance to site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.

https://www.indeed.com/viewjob?t=quality+assurance+specialist+iii&jk=ae48c96b28f0eb8d&_ga=2.263669004.1646275761.1543763749-1408033885.1530798869

Regulatory Submission Writer - Bridgewater, NJ.

Authoring and reviewing regulatory sections for vaccine BLA/MAA submissions. Supports External Manufacturing Department in regulatory filing section authoring for vaccine drug substance, drug product and diluent product production. May also review sections and perform data verification to source information. Coordination and preparation of technical and summary reports to support regulatory submissions. Author and review of drug substance, drug product, and diluent process qualification and production filing sections.

https://www.indeed.com/viewjob?t=regulatory+submission+writer&jk=063a4a324e24e37d&_ga=2.2494256.1646275761.1543763749-1408033885.1530798869

Clinical Data Management, Rave - Princeton, NJ.

Plan, implement, and coordinate clinical data management activities supporting Phase I-IV clinical trials from study start-up to database close in a paper or electronic environment. Represent Data Management for assigned therapeutic area programs. Serve as the Data Management study team leader for multiple studies.

https://www.indeed.com/viewjob?t=clinical+data+management+rave&jk=1e160592ad4109c1&_ga=2.57959466.1646275761.1543763749-1408033885.1530798869

Regulatory Affairs Associate, CMC - Boston, MA.

Responsible for management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. To work closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings. Expertise with biologics and/or drug/biologic/device products is strongly preferred. Responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments.

https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=642e0da0221b7233&_ga=2.32965694.1646275761.1543763749-1408033885.1530798869

Validation Analyst - Princeton, NJ - KatalystHLS.com

Creation of all supporting documentation: technical design, installation documents, integration deployment documents, interface mapping documents. Strengths should include functional knowledge of various testing types & technologies, client interactions, handling teams, project planning and co-ordination of team in varied geographies.

https://www.indeed.com/viewjob?t=validation+analyst&jk=ab25fd90d598711e&_ga=2.263694220.1646275761.1543763749-1408033885.1530798869

Regulatory Operations Consultant - Lawrenceville, NJ.

Manage the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with the client.

https://www.indeed.com/viewjob?t=regulatory+operations+consultant&jk=87b1356616a458d4&_ga=2.14934518.1969368399.1543686974-1024118673.1543686974

Regulatory Operation Specialist - Boston, MA - Indeed.com

Responsible for the Document management activities, operations related to quality and regulatory activities, Configuration activities, Quality Checks activities, IND work, implementation of an EDMF, Regulatory Compliance experience, Management level experience of a project, Will be using Veeva Vault but not mandatory.

https://www.indeed.com/viewjob?t=regulatory+operation+specialist&jk=d7310dc3a3b31fbd&_ga=2.14934518.1969368399.1543686974-1024118673.1543686974

Regulatory Affairs Associate, CMC - San Francisco, CA.

Responsible for management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. To work closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings.

https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=dd0e844b838c6d33&_ga=2.14934518.1969368399.1543686974-1024118673.1543686974

Regulatory Publishing Consultant- Philadelphia, PA.

Prepare the submissions for ANDAs, amendments, supplements, annual reports to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings to Manager, RA for a timely resolution.

https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=d94488d882326d86&_ga=2.14934518.1969368399.1543686974-1024118673.1543686974

Regulatory Submission Writer - Boston, MA.

Authoring and reviewing regulatory sections for vaccine BLA/MAA submissions. Supports External Manufacturing Department in regulatory filing section authoring for vaccine drug substance, drug product and diluent product production. May also review sections and perform data verification to source information. Coordination and preparation of technical and summary reports to support regulatory submissions.

https://www.indeed.com/viewjob?t=regulatory+submission+writer&jk=3dc39782a6996688&_ga=2.114976199.1969368399.1543686974-1024118673.1543686974

Regulatory Publishing Specialist - Boston, MA - KatalystHLS.com

Prepare the submissions for ANDAs, amendments, supplements, annual reports to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA.

https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=7c1c884792e99959&_ga=2.14934518.1969368399.1543686974-1024118673.1543686974