Director of Quality Assurance and Quality Systems, 1000320
Job Scope & Purpose:
Our exceptional Greater Boston area client, with multiple clinical assets focusing on targeted therapeutics in oncology and rare disease, is seeking a Director of Quality Assurance and Quality Systems to join their growing organization. The ideal candidate will manage and provide continuous improvement of the company’s QMS, oversee GXP training for the organization, and review GMP documentation to support manufacturing initiatives on multiple programs. If this is the type of opportunity that interests you, and you are excited to join an established company with a strong leadership team and great company culture, then reach out to Todd Jamison for more information today!
Primary Job Responsibilities:
- Provide continuous improvement and management of the company’s Quality Management System, including, but not limited to, Standard Operating Procedures (SOPs), Vendor Qualification, CAPA, Document Control, Change Control, Deviations and Investigations, Complaint Handling and Internal Audits
- Manage all training programs for team members overseeing GXP activities
- Serve as a Subject Matter Expert on GXP compliance
- Provide guidance in preparation for and represent the company in regulatory inspections and diligence activities
- Review GMP documentation, including Analytical Methods, Specifications, Qualification, and Validation protocols and reports, Batch Records, CMO Certificates of Analysis/Conformance, Stability Reports and Protocols, and Audit Reports
- Enable continuous compliance with international quality standards, identify proactively compliance issues and risks, and regularly provide reports to senior management on compliance activities
Primary Job Requirements:
- BS degree in a related field, with a minimum of 10 years Quality Assurance experience in pharmaceutical or biotech industry
- Proven experience implementing Quality Systems in a regulated environment is required
- Strong knowledge of international GMP regulations and guidelines is required
- Strong understanding of manufacturing processes and operations 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.
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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 844-463-6178
Document Management Systems
Corrective And Preventive Action (Capa)