QA, Quality System and Compliance, Sr. Manager/ Associate Director
Associate Director of GxP Quality Systems and Compliance 1269593
Job Scope & Purpose:
Our client is a global emerging powerhouse in the nucleic acid therapeutics space growing a global team and in need of a seasoned Associate Director of Quality Systems and Compliance to provide leadership, guidance, and oversight of the Quality Systems. This cross functional leader will establish and implement Corporate Quality standards, ensure site procedures, processes and systems meet current GxP and regulatory expectations. You will serve as point of contact for Quality with external partners. Review deviations and perform regulatory assessment for change controls as well as manage/attend periodic business reviews with the CRO/CMO. This hire will also ensure inspection readiness for the global organization and establish regulatory review, internal audit and oversee the quality risk management program. This job has the flexibility to be hybrid, based out of Boston, MA.
Primary Job Requirements:
- 8y+ in a cGMP regulated Quality Systems setting
- Experience with Quality System management, CAPA, deviation investigation and change control is required.
- Experience with external supplier quality management
- Thorough knowledge of international GxP and pharmaceutical regulatory requirements
- Strong team player with the ability to influence across the organization
- Able to work collaboratively with a growing global team
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.
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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.