QA Manager

Nature and Scope

The Quality Assurance Manager, External Manufacturing will be primarily responsible for supporting GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. This position will act as the lead Quality point of contact for assigned projects. Primary responsibilities include support for all aspects of pharmaceutical lifecycle management including process development, commercial manufacturing and testing/release of drug product.

Essential Duties and Responsibilities

• Provide day to day quality input and oversight for successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners globally, ensuring compliance with cGMP, Quality Agreements, regulatory standards and the American Regent Quality Management System.
• Ensure high performance of third-party finished product contract manufacturers by establishing Quality KPI scorecard for compliance and performance metrics.
• Drive timely decisions and facilitate active communication and information flow between contract manufacturer and American Regent functional teams.
• Ensure Quality and Compliance related matters meet appropriate GMP and regulatory requirements to ensure product is safe, pure, and effective.
• Support Supply Chain Operations related to commercial product distribution and timely launch of new products, including serving as Quality lead for technical transfer activities, supporting regulatory filings, and facilitating approval or release of commercial product.
• Verify corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action.
• Investigate and determine the need for and manage any field alerts or recalls/withdrawals of company products manufactured by third party contract manufacturers.
• Review and approve quality records/documentation from third parties, including product and process change controls, stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation.
• Perform on-site visits during manufacturing/packaging of American Regent products and create quality business review process.
• Initiate and attend periodic meetings with CMO as ARI QA representative.
• Make quality decisions on CMO/Suppliers related tasks and events.
• Provide status updates on CMP related tasks and action items to multiple internal departments.
• Monitor/track the relationship between ARI batches to CMO batches.
• Provide information and documentation needed for shipping products between ARI and CMOs.
• Monitor/track/trend batch disposition from CMOs and create CMO related tasks tracking documents.
• Review and approve CMO/Suppliers executed batch records and batch disposition documents.
• Create and provide various CMO requested documents.
• Notify CMOs for any internal events requiring 3rd party notifications and follow up on 3rd party review status.
• Review and approve ARI batch disposition documents and create CoC.
• Support regulatory agency inspections.
• Routinely interact and establish solid working relationships with all functional areas at American Regent.
• Participate in Regulatory and American Regent inspections of external manufacturing partners to ensure successful inspection outcomes and maintain inspection readiness.
• Perform quality risk assessments and drive risk reduction improvement plans and remediation where necessary.
• Develop and revise necessary company policies and procedures to support management of third-party contract manufacturers and external service providers.
• Develop and foster positive relationships with CMO while holding CMOs accountable.
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.

Education Requirements and Qualifications

• Bachelor’s Degree in Engineering or science discipline or related field required.
• Minimum 8 years’ experience in Pharmaceutical QA preferred, with preferences of External Quality Management and sterile injectables.
• Strong working knowledge of current Good Manufacturing Practices, FDA and ICH Q8/9/10/12 guidelines.
• Direct experience participating and supporting regulatory inspections and submissions preferred.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented while managing multiple projects simultaneously.
• Ability to travel domestically or internationally 5-10% preferred.
• Experience with Microsoft Office.
• Excellent organizational, interpersonal, and communication skills (oral and written).
• Demonstrated experience with use/governance of electronic Quality Systems preferred.