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Quality Assurance Manager

BioSpace
  • GB
    London, England, United Kingdom
  • GB
    London, England, United Kingdom

À propos

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.
Typical Day
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.
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.
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  • London, England, United Kingdom

Compétences linguistiques

  • English
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