The External Quality Manager is responsible for managing all quality related activities and requirements between Company and Contract organizations that manufacture, package, test, store and distribute drug products for our Company.
The responsibilities of this position include assuring that products are manufactured, packaged and tested from approved processes and methods in conformance with all applicable regulatory requirements and Company policies. The External Quality Manager will actively monitor and maintain Contract organization compliance and will ensure quality performance through direct oversight, technical advice, and counseling.
The External Quality Manager will drive collaboration within internal and external cross-functional groups to achieve project objectives, and will communicate company expectations as necessary to improve relationship performance against agreed metrics and business goals.
Essential Responsibilities: - Perform due diligence and routine audits of Contract organizations - Assure that all Contract organizations are selected and managed to ensure reliability of supply, quality of products and compliance with GMPs and applicable regulations - Provide oversight and support for the implementation of product launch plans to ensure product is available within project timelines - Develop and maintain Quality Agreements - Conduct batch disposition and release activities - Support product lifecycle management through review and approval of change controls, validation documents, investigations, CAPAs, etc - Maintain Quality KPIs, scorecards, and risk remediation plans of Contract organizations - Assist with regulatory inspections and support regulatory commitment development - Provide support regarding technical, inspectional and compliance issues as needed - Partner with Operations, Supply Chain, Compliance and Regulatory Affairs on supplier quality related matters - Perform Annual Product Reviews and Continuous Process Verification (where applicable)
Preferred Skills and Qualifications: - Thorough understanding of current Good Manufacturing Practices and applicable regulatory requirements, including, but not limited to 21CFR 210 and 211 - Ability to independently manage multiple priorities, projects and systems in a fast paced environment - Ability to lead and support cross functional teams across multiple levels, including Site Management - Excellent interpersonal skills. - Must work well in a team environment and must be able to build and maintain effective working relationships across multiple levels - Strong communication (oral / written) and presentation skills - Detail oriented with strong technical writing background - Demonstrated critical thinking and problem solving skills, including Lean Sigma - Previous 3rd Party experience preferred
Education and Experience: - BS degree required, preferably in Biology, Chemistry, Engineering (or equivalent) - A minimum of seven (7) years’ experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control - CQA, CQE, or SQM qualifications a plus