Rate:-Open

• The QA Manager will provide leadership and guidance for aproduction Pharma facility. Interpret regulations and implement qualitypolicies, manage quality systems, and assist in facilitating regulatorycompliance inspections. Primary responsibility is leading investigationsrelated to non-conformances.

• Lead investigations for a variety of non-conformances whichmay include deviations, CAPA, OOT, AA, or OOS activities. Identifyappropriate SMEs, gather information/data, prepare investigation reports, andshape corrective/preventive actions to resolve recurring problems withpermanent solutions.

• Under the guidance of the Associate Director of Quality Operations, this individual will review regulatory submissions and source documentation to ensure data integrity.
• This individual will lead and participate in Pre-Approval Inspection (PAI) preparedness activities at internal supply chain operations and at Contract Manufacturing Organizations (CMOs).
• In this role, the individual will manage Contract Manufacturing Organizations (CMOs) involved in production of drugs and medical devices on-behalf of , to supply clinical trials and future commercial products in the United States and Europe.
• Drug production includes drug substance, drug product, labeling, and packaging operations.
• This individual will be responsible for the support of technology transfers, analytical method transfers, and process validations at CMOs.
• The Quality Manager ensures that establishes standards and practices and maintains documented procedures and instructions to satisfy cGMPs and Good Documentation Practices for all clinical and future commercial drug disposition activities.
• This individual will work closely with the CMOs, manufacturing, Quality Control, regulatory, and the clinical and commercial supply chain operations teams to maintain drug product supply as well as ensure readiness for commercial launch.
  

Accountabilities

• Maintaining relationships with partner CMOs, and maintaining quality metrics.
  
• Contribute to and ensure data integrity for regulatory submissions (CTA/NDA).
  
• Lead and participate in activities to prepare for PAI
  
• Support technology transfers, analytical method transfers, and process validation at CMOs in a quality role
  
• Batch record reviews, deviation investigations, Change Control, and on-site coverage of CMO activities as needed
  
• Supporting audits and inspections
  
• Perform functions and makes decision consistent with cGMPs, GDPs and quality governance
  
• Additional duties as assigned.