Sr. Manager, Quality Assurance

Position Summary:

The Senior Manager, Quality Assurance, plays a key role in supporting the release and distribution of commercial medicinal products across the EU/EEA. This position is responsible for overseeing critical Quality Management System (QMS) activities and ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and applicable EU regulatory requirements. The role partners closely with internal and external stakeholders to maintain product quality, patient safety, and regulatory compliance throughout the product lifecycle.

Primary Responsibilities:

• Lead and support core QMS processes, including Management Review and Annual Product Quality Reviews (APQRs).
• Review batch documentation and support commercial product release activities, including deviation management, CAPA implementation, and change control.
• Plan, conduct, and follow up on internal audits, supplier audits, and regulatory inspections.
  • Drive continuous improvement initiatives and support quality risk management.
  • Manage supplier oversight activities, including qualification, performance monitoring, and revisions of quality agreements.
  • Support GDP compliance programs, including transportation and distribution oversight, warehousing activities, temperature excursion management, customer qualification, and recall readiness.
  • Ensure compliance with data integrity requirements and governance of computerized systems, electronic records, and electronic signatures.
  • Collaborate with Regulatory Affairs, Manufacturing, Supply Chain, Distribution, and other cross-functional teams to support compliant product release and distribution activities.
  • Identify, assess, and escalate quality and compliance risks as appropriate.

Education/Experience/Skills

• Bachelor’s degree in a Health Science discipline required; Master’s degree preferred. Equivalent combinations of education and relevant experience will be considered.
• Minimum 5 years of experience within the pharmaceutical manufacturing industry with focus on quality assurance.
• Strong knowledge of EU GMP (EudraLex Volume 4), EU GDP Guidelines (2013/C 343/01), Directive 2001/83/EC, ICH Q7, Q9, and Q10, and other relevant regulatory requirements.
• Proven experience managing outsourced GMDP activities.
• Hands-on experience with electronic quality management systems such as Veeva Vault, TrackWise, or equivalent platforms.
• Strong organizational and project management skills with the ability to manage multiple priorities simultaneously.
• Excellent attention to detail and commitment to quality.
• Effective negotiation and stakeholder management skills.
• Ability to independently assess complex situations, resolve issues, and recommend practical solutions.
• Strong risk-based decision-making and problem-solving capabilities.
• Excellent written and verbal communication skills with the ability to convey complex information to diverse audiences.
• Demonstrated ability to build collaborative relationships and work effectively across functions and external partners.

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 9 kilograms. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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