Sr. Manager, Commercial Quality Assurance, US
The salary range for this position is between $150k and $185k.
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience. The company also currently offers a Long-Term Incentive Plan (cash plan) of 20% base salary, annual performance bonus target of 20% base salary (subject to meeting plan requirements) and comprehensive health benefits, unlimited vacation time and 401k plan.
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
A combination of relevant education and applicable job experience will be considered.
- Qualifications
- 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.
- Career Experience
- 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.
- Business Acumen
- 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.
ETHICS AND COMPLIANCE
- Demonstrates the highest level of ethics, integrity, trust while acting with courage and candor.
- High accountability for your actions and results and ability to ensure a high level of commitment to the success of the organization, your peers and customers.
- Operates in compliance with all applicable regulations and professional standards at all times.
TRAVEL
- The ability to travel up to 10%, including overnights as dictated by business need and attend all company sponsored events/meetings/conferences.
VALUES & BEHAVIORS
- Live Entrepreneurship: Plan for long-term growth and build a future business predicated on innovation.
- Patient Centric: Deliver innovation for patients and challenge each other to improve patient outcomes.
- Join Forces: Seek diverse input, collaborate across all functions, and leverage resources from global partners.
- Act with Integrity: Apply ethical standards, encourage transparency, and embrace diversity and inclusivity.
- Drive Performance: Create an atmosphere that nurtures teamwork in order to enable high performance and sustainable growth.
* If you are a California resident applying for the above position, please review our California Applicant Privacy Notice.
Skills Required
- Bachelor's degree in pharmacy, Chemistry, Biology, Engineering, or related discipline; advanced degree preferred.
- Minimum of 5 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Strong understanding of Good Distribution Practices (GDP) and regulatory requirements.
- Demonstrated knowledge of national and international pharmaceutical regulatory requirements.
What We Do
At Averitas Pharma, we strive to enable people with pain to live and feel more like their true selves. With patients at the forefront of every decision we make, we want more than to envision people not limited by their pain; we work every day with passion and determination to make it a reality. We are currently helping patients by offering the only FDA-approved, non-opioid, topical system for the treatment of neuropathic pain associated with postherpetic neuralgia (post-shingles nerve pain) and for neuropathic pain associated with diabetic peripheral neuropathy of the feet (diabetic nerve pain of the feet). We are proudly building on the 75-year legacy of Grünenthal, a global privately held healthcare company that has been working tirelessly toward a world free of pain by approaching pain as a disease in urgent need of a solution, rather than a mere symptom. We do it because we care. Most of us have either dealt with chronic pain or know someone who has, because it is a burden that far too many people around the world must bear. Our empathy for patients, and our shared sense of mission and purpose, are what inspires us to keep going. And our people are the key to our success. For more information, visit www.averitaspharma.com Community Guidelines: 1. We reserve the right to remove profanity, threatening or harassing content, promotional content and any personal information. 2. Due to FDA fair balance rules, we ask that you not mention any medicines or FDA-approved therapies by name or include links to third-party sites. 3. This site is not a forum for reporting side effects experienced while using an Averitas product. Physicians, other healthcare providers, and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can visit www.fda.gov/medwatch or call 1-800-FDA-1088 For questions about our products call 1-877-900-6479. For more information, ask your healthcare provider or pharmacist
