Sr. Mgr, Commercial Quality Assurance, US

POSITION SUMMARY

The Commercial QA Manager ensures the safe and reliable supply of products to patients by overseeing Quality activities within the commercial distribution network. This role owns the Commercial Quality Management System (QMS), partners with key stakeholders, and ensures all market supply operations meet GDP requirements and internal quality standards. Through proactive quality oversight and cross‑functional collaboration, the manager safeguards product integrity and supports compliant, efficient commercial operations.

KEY RESPONSIBILITIES

• Ensure all distribution, storage, and commercialization activities for pharmaceutical products comply with GRT quality standards and local regulatory requirements.
• Make final decisions on the disposition of products, including release, return, rejection, recall, or management of suspected counterfeit products.
• Implement, maintain, and continuously improve Grünenthal’s Pharmaceutical Quality System within the commercial scope (GDP and GMP), ensuring adherence to current local regulations and global standards (GDP-RP).
• Define, monitor, and analyze Key Quality Indicators (KPIs) to evaluate performance and compliance with established procedures and Good Practices.
• Manage relationships with external partners, including 3PLs, wholesalers, and distributors, ensuring alignment with quality and compliance expectations.
• Serve as the Quality Assurance lead during interactions with Health Authorities for distribution and warehousing matters, ensuring ongoing inspection readiness for both the affiliate and partner sites.
• Develop, deliver, and maintain GDP training programs for affiliate teams, ensuring consistent understanding and application of Good Distribution Practices.
• Plan, control, and monitor the local department’s budget, ensuring efficient allocation of resources and adherence to financial targets.
• Actively contribute to tasks, cross-functional projects, and strategic quality improvement initiatives at both the Country level and within the global organization, providing local expertise and ensuring effective implementation of corporate standards and operational efficiencies.
• Lead periodic Quality Reviews for the commercial area, presenting system performance, identifying gaps, and recommending action plans to drive continuous improvement and inform Management decisions.

QUALIFICATIONS, CAREER EXPERIENCE AND SKILLS

• Bachelor’s degree in pharmacy, Chemistry, Biology, Engineering, or a related scientific discipline; advanced degree (MSc/PharmD) preferred.
• Solid understanding of Good Distribution Practices (GDP) and regulatory requirements within the pharmaceutical sector.
• Strong verbal and written communication skills; able to engage and influence stakeholders at all levels, both internally and externally.
• Minimum of 5 years of progressive experience in Quality Assurance within the pharmaceutical industry with focus on GDP.
• Demonstrated knowledge of national and international pharmaceutical regulatory requirements including FDA, EMA, ICH, and other relevant global health authorities.
• Proven ability to interpret, apply, and ensure compliance across all stages of drug development, manufacturing, and post‑market activities.
• Strong knowledge and understanding of national and international regulatory requirements relevant to pharmaceutical distribution and quality compliance.
• Expertise in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP).
• Ability to implement, maintain, and improve Pharmaceutical Quality Systems within commercial operations.
• Skilled in developing and delivering training programs for cross‑functional teams.
• Proficient in analyzing and monitoring Quality KPIs to drive continuous improvement.
• Experienced in managing relationships with external partners, including 3PLs, wholesalers, and distributors.
• Effective communicator with the ability to interface confidently with Health Authorities and senior management.
• Strong project management skills, with a track record of supporting cluster‑level and global quality initiatives.
• Budget planning and management capabilities within operational quality functions