Associate Director, Compliance
Skills
- Deep experience managing GxP audits (GLP/GCP/GMP) and full audit lifecycle.
- Experience with supplier/vendor assessments and monitoring.
- Strong knowledge of US and international regulatory standards and compendial requirements.
- Proven CAPA management, root cause analysis and investigation skills.
- Excellent written and verbal communication and stakeholder management.
- Ability to lead contractors and cross-functional teams and present metrics to leadership.
Responsibilities
- Develop and implement a risk-based, data-driven annual GxP audit plan (GLP, GCP, GMP).
- Manage full audit lifecycle: scheduling, planning, execution, reporting, response evaluation, CAPA tracking and closure.
- Coordinate cross-functional internal SMEs for supplier audits and pre-audit information gathering.
- Communicate with suppliers to schedule audits, request documentation, deliver formal findings and confirmation of closure.
- Ensure CAPAs are risk-appropriate and aligned with current biologics industry practices.
- Provide oversight to contractor auditors to ensure consistency in observation writing, classification and reporting.
- Design and maintain systems, procedures and templates to monitor and improve the audit program.
- Report GxP audit performance metrics and program maturity to senior leadership and Management Review.
Education
- Advanced degree (MS/PhD) in a relevant scientific or engineering field preferred (Biotechnology, Biochemistry, Molecular Biology, Engineering).
- Bachelor's degree in a relevant field or equivalent experience acceptable.
Benefits
- Fully remote role with up to 20% domestic/international travel.
- Competitive salary (range listed) and potential equity opportunities.
- Health, dental, and vision benefits (typical biotech package).
- Paid time off and company holidays.
- 401(k) or retirement plan options.
- Professional development and training support.
Average salary estimate
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