Job Details

ID #22172013
State Massachusetts
City Clinton
Job type Permanent
Salary TBD
Source Apex Systems
Showed 2021-11-04
Date 2021-11-03
Deadline 2022-01-01
Category Software/QA/DBA/etc
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Senior Manager, GMP Quality Assurance

Massachusetts, Clinton, 01510 Clinton USA
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Associate Director/Senior Manager, GMP Quality Assurance 1195399 Job Scope & Purpose: Our client is looking for an experienced Associate Director/Sr. Manager of GMP QA. This candidate will manage GMP QA activities for therapeutics in clinical development stages. This key role in the Quality team will partner with internal and external CMC teams including supply chain, regulatory, CTL's and CMO's to ensure cGMP compliance, and compliance of procedures and systems. Primary Job Responsibilities:

  • Act as subject matter expert (SME) for GMP QA topics
  • Execution of Company lot disposition packages for drug substance, drug products, and finished clinical trial material
  • Assist in Quality System development; Write, revise, and periodically review SOPs
  • Management of: Document Control, Training, Deviations and CAPAs, Vendor Management
  • Participate in CMC team meetings and others, providing QA support
  • Review of master batch records, specifications, test methods, stability protocols, and reports
  • Review and approve executed batch records, analytical data, change controls, deviations, OOS, etc.
  • Review of CMO lot disposition packages
  • Attend CMO/Company joint team meetings, follow through open quality events
Primary Job Requirements:
  • BS/BA in Chemistry, Biology or a related life science; 6+ years of experience within GMP quality functions of pharmaceutical/biotech industry
  • Be independent and proactive
  • Strong execution of day-to-day activities
  • Have experience working in a small-team, dynamic environment
  • Experience in auditing CMOs and CTLs is a plus
About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Code:TechOps

EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

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