Associate Director / Auditor, Quality Compliance and Audits
Skills
Warehouse Operations21 CFRAdoptionBiotechnologyCFRContextMedical Devices
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor's Degree and Ten Years' Experience
- OR Master's Degree and Eight Years' Experience
- OR PhD/PharmD and Five Years' Experience
- Relevant scientific or technical degree preferred
- 10+ years relevant GMP/GDP audit experience in pharma or biotech
- Demonstrated biotechnology and/or pharmaceutical industry experience
- Proven independent GMP/GDP auditor experience
- In-depth knowledge of GMP GDP and global regulatory requirements
- Strong understanding of manufacturing testing and distribution operations across multiple dosage forms and technologies
- Strong working knowledge of risk-based auditing methodologies and full audit lifecycle
- Ability to interpret and apply evolving regulatory expectations and quality standards
- Excellent written verbal and interpersonal communication skills
- Strong organizational leadership and time-management skills
- Ability to work independently manage priorities and exercise sound judgment
- 50% travel required
Nice to have
- independent
- cross-functional
- risk-based
- detail-oriented
- organized
- collaborative
Day to day
- Lead and support global GMP and GDP audits across internal manufacturing sites and external partners, including manufacturers laboratories suppliers distributors and third parties.
- Manage the full audit lifecycle from planning and scheduling through execution reporting and follow-up CAPA assessment.
- Develop risk-based audit strategies and collaborate cross-functionally to gather background information assess risk and deliver effective quality oversight.
- Identify compliance gaps quality risks and systemic issues while contributing to continuous improvement of audit tools procedures training and metrics.