Yoh is looking for a Manager, Quality Compliance & Audit for a large client in San Diego, CA!
The purpose of this position is to manage and oversee the Quality Compliance function and its primary activities which include implementation and maintenance of the Quality Assurance GXP Internal and External Auditing programs and to ensure compliance with that program. Audits will be focused primarily on current Good Manufacturing Practice (GMP) but may also include, current Good Laboratory Practice (GLP), current Good Clinical practices (GCP) and audits of critical computerized systems.
The position will support internal and external Company initiatives in a compliance-related manner such as health authority inspection readiness, assessment of CMO compliance, and risk assessment and investigation activities. The position will also be responsible for managing the execution of Quality Agreements as well as other GXP auditors and contractors acting on behalf of Company.
- Prepare annual Master Audit Schedules and execute to defined timeline in accordance with Company procedures.
- Manage GXP auditors.
- Perform GXP audits both internal and external per Company's annual Master Audit Schedule as needed.
- Manage Approved Supplier/Vendor List.
- Support regulatory authority inspections and partner audits.
- Support compliance with pharmacovigilance requirements including periodic audits of contractors and business partners as needed.
- Ensure timely completion of commitments from regulatory agency inspections and partner audits.
- Ensure timely completion of Corrective and Preventative Actions (CAPAs) as needed.
- Create and author Standard Operating Procedures (SOPs) as needed to support compliance of the operations.
- Recommend corrective and preventative actions as needed to support compliance within the department.
- Manage and maintain the Quality Agreements.
- Other duties as assigned.
- Minimum 5 years of relevant Pharmaceutical Industry Quality Assurance experience.
- BS/BA degree in scientific discipline or equivalent experience.
- Ability to conduct GXP audits and manage the outcomes.
- Ability to manage direct reports.
- Strong knowledge of US and EU GXPs and their application.
- Ability to work proactively and cooperatively with managers and operation staff to solve quality problems.
- Ability to manage multiple responsibilities with a high degree of self-motivation.
- Good written, oral and interpersonal communication skills.
- Understand purpose and application of Quality Agreements.
- 50% domestic/international travel required.