Associate Director, Global Product Quality

Job Description
Associate Director Quality Management Commercial Products develops, implements, and maintains the quality systems and tools required to manage and monitor the quality and compliance aspects of company commercial products.   
He/She will lead the team of staff to provide all Quality support to commercial production and release.
Other responsibilities to include:
- Establishes strategies to meet Quality Management Commercial business goals and partners with department leadership to ensure goals are met
- Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting Commercial Product (API, drug product, and final finished product).
- Oversees Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above.
- Works collaboratively within the Quality Management Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance.
- Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests.
- Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above.
- Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting Commercial Products.
- Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations. OOS incidents, rejects, etc.
- Provides reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests.
- Conducts audits of Contract Manufacturers/Laboratories (as part of an audit team) that support Commercial Products to ensure compliance with OAPI and OPDC requirements as well as applicable regulatory requirements
- Interfaces with project teams supporting Commercial Products to assure that the goals set by the team as they relate to Contract Manufacturing/Laboratory Operations meet the required timelines and are consistent with OAPI quality objectives and relevant governmental requirements.
Required:
- Bachelor’s degree in Chemistry, Biology or other Physical Sciences + 10 years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles supporting commercial product and development project activities.
- 5-10 years of supplier QA experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.
- 2 years in leading …