Senior Director, Quality Assurance
Senior Director, GxP QA (Biologics) 1271643
Job Scope & Purpose:
Our expanding biotech client is making a difference in the fight to understand and stop cancer. We’re on the hunt for a head of QA who will oversee the expansion of the quality system as the company prepares for inspection readiness. You will collaborate internally and externally leading a cross functional team to provide oversight of Quality efforts ensuring GxP practices are implemented and followed in accordance with cGMP, GCP and GLP standards. This opportunity has the flexibility to be hybrid and is based out of Cambridge, MA.
Primary Job Responsibilities:
- Lead the development of GxP quality infrastructure needed to support late stage clinical and commercial/launch using external CDMO’s and CTL’s
- Manage vendor qualification and audit programs
- Manage and mentor existing QA personnel and plan for the growth of the department and quality program.
- Perform quality assurance activities associated with cGMP manufacturing, investigations, change control, investigations, and documentation.
- Participate in batch release including the review of batch records, QC testing, SOPs, and other batch related documentation and lot release data.
- Lead training and implementation of GXP procedures and quality systems.
Primary Job Requirements:
- BS/ MS with 10+ years of GxP Quality compliance experience managing and implementing Quality Systems
- Experience in the implementation and maintenance of GxP quality systems including auditing and vendor qualification
- Knowledgeable in managing GMP compliance at outsourced manufacturing sites
- Strong understanding of GMPs as they apply to early development and commercial products
- Previous BLA experience is required
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.
jditalia@stratacuity.com
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 employeeservices@apexsystemsinc.com or 844-463-6178.