AddressSummary: Provide oversight of quality operations relating to supply of product within UK and Europe and the wider EMEA (Europe, Middle East, and Africa) region, including Management of quality operations for Distributor Markets within the region. Management of storage and distribution activities in the UK and European market.
Manage and maintain control of key documents, data and processes that support the activities of the Wholesale Dealers Authorisation (WDA) in the UK providing day-to-day operational activity support, contributing where necessary; to vendor / customer audit and evaluation activities (both remotely and on site) and more generally, ongoing vendor / distributor management activities, to deviations, to change controls and to product quality complaints. Provide direct quality operations support to resolve day to day product supply related issues and lead key projects from a Quality Assurance SME perspective, supporting product launches into new markets, including the identification, due diligence, and qualification of new supply partners.
Essential Duties and Responsibilities include, but are not limited to, the following:
Author and where necessary, approver for quality owned SOPs for QAD
Management and resolution of Temperature excursions
Support the maintenance of operational Authorisations in the region, including WDAs and MIAs that facilitate product supply
Support WDA activities to ensure the remit of the licence are met,
Support REGN UK and affiliates as required, with their inspection readiness programs
Ensure relevant Quality Assurance/Technical Agreements are kept up to date with suppliers and are periodically reviewed.
Collaborates across local and global QA teams to help provide support and drive teams to the most compliant, quality outcomes.
Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
Represents the IOPS organization on behalf of QA with external partners and suppliers to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.
Provides QA direction for cross-functional teams. Can serve as an escalation point when additional escalation within Quality and the business is required.
Maintain, where necessary, technical agreements with distributor partners and collaborate with the key stakeholders where the distributor partner also acts as the Marketing Authorisation holder
In conjunction with Logistics, review temperature excursions reports and support investigations, identifying appropriate CAPAs. Evaluate and produce relevant disposition statements for batches /shipments subjected to temperature excursions.
Support Change Owners for changes in the business and act as change owner where necessary for Supply related projects and quality owned changes.
Provide SME input and assessment to supply changes within the region and ensure quality actions associate with supply chains are made in a timely manner.
Education and Experience:
Life Science degree ideally in Chemistry or a Pharmaceutical science.
Good organisation and planning skills
Excellent communication skills, and negotiation skills.
Good knowledge of Quality Management Systems and their application in the Pharmaceutical or similar industries.
Positive, proactive approach to drive assignments/tasks to completion
Ability to handle multiple assignments and changing priorities.
Ability to prioritize, manage multiple tasks, and meet deadlines; courage to change and embrace change.
Ability to resolve conflict with tact and diplomacy.
Knowledge and familiarity with the virtual Supply chain environment and the management of commercial product through the supply chain.
Strong working knowledge of European GDP and The Human Medicine Regulations 2012 (as amended)
Experience of working in a document control department within Healthcare, Pharmaceutical, or Medical Device related industry is an advantage.
Experience in audit management and or vendor / customer management programs is an advantage.
Fully understanding of typical regulatory requirements relevant to a European regulated product e.g., EU GMP &GDP, and basic understanding of US regulations such as CFR 21 Part 210/211/820 and other market regulations.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
