Associate Director, Supplier Quality
Thousand Oaks, CA
The Associate Director, Supplier Quality will lead a Supplier Quality Team ensuring implementation of a phased appropriate program. This individual will simultaneously lead supplier qualification and supplier monitoring activities for the site and will be a quality expert for Suppliers and Service Providers (Direct and Indirect). The Associate Director, Supplier Quality will also support cross functional teams for supplier selection, due diligence activities, and quality system processes.
- Responsible for the Supplier quality process and program including material suppliers and service providers (direct and indirect).
- Define the Supplier Quality Plan strategy to support business requirements.
- Lead a Supplier Quality Team.
- Independently prepares, conducts, and reports results of audits of GMP service providers and suppliers of various GMP materials and internal processes to meet quality compliance requirements.
- Responsible for training of internal and supplier audit team members.
- Creates and maintains a list of approved suppliers/service providers.
- Maintain policies, procedures, checklists, self-assessment surveys, and additional forms for the internal and supplier audit programs.
- Monitors raw material supplier quality and works directly with Supply Chain, QA, and suppliers to improve performance.
- Oversee and report on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings.
- Supports Quality management contact with the FDA, EMA, and other regulatory authorities worldwide, as well as partners regarding quality issues including field alerts, recalls, or regulatory actions.
- Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
- Bachelor's Degree in Natural Sciences preferred.
- 10+ years direct experience, or related experience in Supplier Quality.
- 8+ years of experience in pre-pivotal, pivotal, and GMP commercial drug quality operations; including 5 years of experience in GMP auditor lead role and 2 years of GMP manufacturing site experience performing QA oversight. 2 years of experience supporting clinical phase cGMP Quality operations is a plus.
- 5+ years' experience managing teams.
- Solid understanding of quality management systems and continuous process improvement principles including global cGMP requirements and other relevant regulations and guidance to assure quality products.