Senior Manager, Quality Compliance

Key Responsibilities

• Serve as a key contributor on the QA Compliance team, leading and supporting the delivery of essential compliance programs and activities
• Own the end-to-end product complaints program, overseeing intake, assessment, investigation, and resolution of both clinical and commercial products
• Collaborate with cross-functional teams to Ensure proper assessment of complaint events against MIA license, MAH, and country/territory-specific requirements, as applicable, including regulatory compliance for reporting, as well as resolve manufacturing or distribution issues
• Drive thorough investigation and analysis to determine if a product is defective
• Monitor complaint events for trends and prepare the necessary information for reporting to senior management and improvement of the QMS
• Act as a point of contact with contract service providers in the complaint handling process
• Support the monitoring of regulations and industry standards for new requirements and emerging trends and support cross-functional assessments to identify recommendations to meet such requirements or address such trends
• Support preparation of anticipated regulatory inspections (PAI, routine inspections, including those at contracted organizations), and partner audits with cross-functional teams
• Support cross-functional teams and training of team members in preparation of partner audits and inspections
• Establish and improve policies, procedures and systems that enable clear oversight of internal and external GMP activities
• Develop meaningful metrics and interpret results to understand the health programs/systems in relation to other quality programs/systems
• Participate in cross-functional teams representing Quality as appropriate
• Stay current with GxP regulations, guidelines and industry practices and pro vide timely updates to cross-functional teams, as necessary
• Support internal/external audits, as needed

Qualifications & Experience

• Bachelor’s degree (BSc) or higher in a relevant scientific discipline
• Minimum of 8+ years’ experience in pharmaceutical or biopharmaceutical manufacturing and quality
• Direct experience with Product Quality Complaint handling within the US and EU is required. Experience in other territories is preferred.
• Strong working knowledge/interpretation of global GMP/GDP regulations and emerging regulatory trends
• Experience working with external partners or contract organizations, including Quality oversight
• Experience dealing with regulatory authority inspections is preferred
• Strong investigation handling, communication (written/verbal), problem-solving skills
• Able to influence and collaborate effectively across all organizational levels
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Able to navigate through ambiguity and identify appropriate solutions in order to progress activities
• Excellent organizational skills with the ability to manage multiple priorities effectively
• Proficiency in Microsoft Office applications
• Able to travel up to 10% annually