Associate Director/Director, Quality Assurance, Systems
Director of Quality Systems 1346243
Location: Boston area (Hybrid)
Science/ Focus: Small molecule Therapeutics
Job Overview: This Quality Systems head will ensure GxP quality systems are appropriately designed, implemented and measured for compliance and effectiveness and will lead Quality System changes and continuous improvement initiatives.
Responsibilities:
- Own the Quality System function including Deviation Management (Non-Conformances), CAPA, Change Control, and Risk Management processes
- Manage/ evaluate the eQMS, including user training
- Oversee Quality Management Review process and meetings
Requirements:
- BS or MS with 8-10+ years in pharmaceutical GxP quality assurance
- Strong experience with quality risk management and investigations (Deviations, CAPAs, Change Control)
- Experience with FDA inspections and inspection readiness
- Experience with implementing an eQMS is ideal
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.
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@apexsystems.com or 844-463-6178.