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
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