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Regeneron

Quality Assurance Manager

Reposted 11 Days Ago
Be an Early Applicant
In-Office
Uxbridge, ON
Mid level
In-Office
Uxbridge, ON
Mid level
The QA Manager oversees quality operations, ensures compliance with regulations, manages distribution activities, and leads quality assurance initiatives in pharmaceutical distribution.
The summary above was generated by AI

At Regeneron, we are dedicated to transforming lives through science and innovation. We believe in fostering a culture of collaboration, excellence, and continuous development. We are looking for a dedicated Manager QA to join our team in Uxbridge, UK. As a key member of the Quality Assurance Distribution (QAD) team, you will play a vital role in overseeing quality operations, managing storage and distribution activities, and ensuring compliance with regulatory requirements across the UK and European markets. This is your chance to create a meaningful impact on the quality and supply of life-saving products.

A Typical Day:

As the Manager QA, you will:

  • Fulfill Responsible Person (RP) duties to ensure compliance with the Wholesale Dealers Authorisation (WDA) licence requirements.

  • Oversee quality operations for distributor markets and marketing authorisation holder (MAH) activities.

  • Manage storage and distribution activities in the UK and European markets to ensure smooth product supply.

  • Support inspection readiness programs for Regeneron UK and affiliates.

  • Author and approve quality-owned Standard Operating Procedures (SOPs) for the QAD team.

  • Investigate and resolve temperature excursions in the UK and global markets, implementing corrective and preventive actions (CAPAs).

  • Collaborate with distributor market partners to ensure effective due diligence, qualification, and relationship maintenance throughout the product life cycle.

  • Provide subject matter expertise and lead quality assurance initiatives for product launches into new markets.

This Role May Be For You If:
  • You thrive in dynamic environments and enjoy managing quality operations for complex supply chains.

  • You have a keen eye for detail, ensuring compliance with European Good Distribution Practice (GDP) and The Human Medicines Regulations 2012.

  • You excel at building and maintaining effective partnerships with vendors and distributors.

  • You are passionate about ensuring quality and regulatory compliance in pharmaceutical distribution.

  • You are skilled at conducting audits, managing deviations, and implementing CAPAs.

  • You are motivated by opportunities to contribute to product launches and supply chain projects.

To Be Considered:

You must have a Life Science degree, ideally in Chemistry or Pharmaceutical Science. Experience as a named Responsible Person (RP) on a licence (preferred). You have a strong knowledge of Quality Management Systems and their application in pharmaceutical or similar industries. You are familiar with the virtual supply chain environment and management of commercial products through the supply chain. Preferred qualifications include experience in audit management, vendor/customer management programs, document control, and pharmacovigilance systems.

At Regeneron, we are committed to encouraging a diverse and inclusive work environment. If you are ready to take on an impactful role in quality assurance, we encourage you to apply today!

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Top Skills

Capas
Good Distribution Practice
Pharmacovigilance Systems
Quality Management Systems

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