Compliance QA Director
$190,000–$269,000 year
On-site · Alameda, California, United States
Job Summary
The Compliance QA Director leads GxP inspection readiness and oversees health authority inspections and responses. Responsible for setting the strategic plan for organizational inspection readiness, developing an annual readiness plan, guiding internal audits and mock inspections, and driving timely closure of corrective and preventive actions. Serves as the compliance SME for global regulatory expectations, reviews regulatory changes, and provides guidance on GxP processes. Partners cross-functionally with Regulatory Affairs, Clinical Operations, Drug Safety, Pharmaceutical Operations and Supply Chain, and Non-clinical Development to ensure ongoing inspection preparedness and continuous improvement. Manages contract auditors, external vendor audits under the Supplier Quality Management program, and ensures tools and processes are fit for purpose. Requires 11–13 years of relevant experience in GxP quality compliance or quality assurance with leadership in inspection readiness and audits; strong ability to lead cross-functional teams and communicate effectively; travel up to 20%.
Required Qualifications
- Bachelor’s degree in biology, sciences, or related STEM disciplines
- 13 years of relevant experience in audit and inspection management within pharmaceutical quality compliance or quality assurance; or Master’s degree with 11 years of relevant experience; or equivalent combination
- Experience supporting regulatory health authority inspections, including preparation, documentation review, coordination of activities, and post-inspection actions
- Ability to influence others as part of a collaborative team and negotiate effective solutions
- Strong written and oral communication skills; attention to detail and organizational skills
- Working knowledge of regulatory requirements and quality standards; proficiency with Microsoft Office
- Demonstrated leadership in inspection readiness and audits; independent contributor with minimal supervision
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