DIRECTOR OF Quality Assurance
Pharmaceutical & Medical Device
Santa Rosa, California
- Lead a QA team to develop, direct and maintain a cGMP compliant quality system throughout the company.
- Effectively analyze, develop and implement systems, processes and equipment in compliance with ISO and FDA requirements.
- Direct internal and external audits.
- Develop and implement quality control process sampling systems, procedures, and statistical techniques.
- Maintain and direct all cGMP/ISO Quality Assurance related requirements and responsibilities.
- Support the CAPA process, collaborate with owners to ensure effective root cause analysis and the development of innovative, long-term solutions.
- Maintain metrics for quality systems including supplier quality, non-conformances, and CAPA.
- Tracks the effectiveness of corrective action plans and compliance improvement initiatives.
- Responsible to review and establish quality goals within the company on an annual basis.
- Experience with Design Control (i.e. Design input/output),
- Experience in leading new validation activities for processes, products and engineering.
- Experience in the development of a design master file, FMECA and PFMECA
- Experience with test method validations.
- Experience working across different department teams such as: QA, QC, Regulatory, Manufacturing, Inventory, Marketing.
- Minimum of B.S. in life sciences, engineering, or equivalent required.
- Advanced degree preferred.
- Minimum 7-10 years of experience in Quality Assurance for pharmaceutical and medical device biopharmaceutical companies.
- Experience with successful FDA and international agency negotiations and audits.
- Excellent verbal and written communication skills.
- Detail oriented with well-developed organizational and analytical skills.
- Suited to working in a fast-paced, small company environment.