Sr Director Quality
July 24
🏢 In-office - San Francisco
Description
• Ensure cGMP compliance against 21 CFR Parts 117, 110, 101 and 11, as appropriate • Serve as subject matter expert (SME) and hold overall responsibility for implementation, direction and coordination of the QA, QC and Quality Systems functions; specifically: • Quality on the floor • Raw material inspection and release • Disposition of product • Method validation, process validation, and equipment/utilities qualification • Laboratory and cross contamination controls • Internal auditing • Lead and manage regulatory and certification inspections • Quality event investigations and CAPA management • Change management and document/records management • Risk management • Data integrity • Quality metrics reporting/Management Review • Technology transfer • Stability program • Training program • Maintain 3rd party certifications as appropriate, eg. Safe Quality Food (SQF) and non-GMO certifications • Lead, assess, mentor and develop departmental associates and analysts. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members and train relative to responsibilities. • Establish Quality strategy, policies, define roles and problem solve. Collaborates with other Departmental Leaders on continuous improvement initiatives. • Key, pro-active contributor to long term strategic planning and part of leadership team.
Requirements
• B.A./B.S. or M.S. in Biology/Biological Sciences, Food Science or related discipline. Ph.D. is a plus. • 15+ years industry experience in Quality. Working with food/dietary supplements is preferred. Experience with microorganisms is a plus. • Proven experience as Quality site head/leadership role, including establishing and growing a successful Quality function in a start-up environment. • Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA regulations and or guidance documents. Knowledge of international markets is a plus. • Excellent communication (written and verbal) and organizational/time management skills • A demonstrated track record in the following key areas is required: • Regulatory Agency and Certification (e.g. SQF, NSF, etc.) Inspection management. • Collaboration and team building skills. High level of integrity and personal responsibility. • Innovation and strategic thinking. Initiative and decision making. • Identification and selection of eQMS • Onsite position
Benefits
• Medical, Dental, and Vision • Commuter Benefits • Life & STD Insurance • Company match on 401 (k) • Flexible Time Off (FTO) • Equity
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