QA Manager

Job#: 1376344

Job Description:

Quality Assurance Manager 1376344
Location: Cambridge, MA (Hybrid)
Science: T-Cell Therapies
Therapeutic Area: Oncology
Job Overview:  The Quality Assurance Manager oversees and manages all quality assurance functions, including laboratory protocols, data review, deviations, and product complaints, to ensure timely release of products and drive continuous improvement.
Requirements:

• Review and approve quality control method validation protocols, stability protocols, and raw material data forms and specifications.
• Ensure timely completion of quality assurance documents such as Standard Operating Procedures, Deviations, Change Controls, and Validation Protocols and Reports.
• Manage the receipt and processing of Supplier Change Notifications and the investigation and closure of Product Complaints and Supplier Complaints

• Minimum of 8-10 years experience in biotech or pharmaceutical environment, with a BS in a scientific discipline, and excellent verbal and written communication skills are required.
• Thorough knowledge of quality requirements for clinical and commercial manufacturing processes, cGMP, ICH, FDA/EMA, and Quality Systems
• Knowledge of root cause analysis tools and ability to lead project teams in first-time initiatives are required, along with desire to work effectively in interdisciplinary teams.
• Previous experience in a cell therapy firm, ability to build high performing teams, and experience working with CMOs in the UK and EU

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.
[email protected]

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 [email protected] or 844-463-6178.