QA Manager GMP

2 weeks ago

Egham UK, Surrey, United Kingdom Essential Pharma Full time

Essential Pharma are seeking a QA Manager with deep GMP knowledge. You will be responsible for the operational management of quality assurance activities related to the subcontracted manufacturing operations of Essential Pharma products, ensuring compliance with regulatory requirements, and maintaining high standards of product quality and safety. As a market authorization holder, you will be ensure our responsibilities are fulfilled and that any product related quality events are under control. Apply Today


What You Will Do


  • Reporting into the Associate Director QA –GMP Operations, you will participate in the maintenance of the Quality Management System (QMS) in compliance with regulatory standards (e.g., FDA, EMA, ICH).
  • Ensure that all QA processes and procedures are documented, followed, and continuously improved.
  • Conduct internal / external audits and participate to regulatory inspections .
  • Ensure that all products comply with relevant regulations and guidelines.
  • Stay updated with changes in regulatory requirements and ensure timely implementation of new regulations.
  • Prepare for and participate in regulatory inspections and audits, including visiting CMO partners.
  • Manage risk, documentation and reporting.
  • Collaborate with cross-functional teams, including manufacturing, supply chain, MSAT, R&D, and regulatory affairs, to ensure product quality throughout the product lifecycle.
  • Drive continuous improvement, train and embed best practice within quality across the company.


What We Do


Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.

We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.

Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office, five minutes’ drive from Egham Train Station situated on the Thorpe Industrial Estate. We also have colleagues based in Malta, France, Spain and Switzerland.


What You Will Bring


  • Bachelor’s degree in Pharmaceutical Science, Biologics, Biotechnology, Biochemistry, or a related field.
  • Proven experience in quality assurance within the pharmaceutical industry. Experience in manufacturing operations of medicines is essential, biological products is a plus.
  • Deep knowledge of Good Manufacturing Practice.
  • Excellent communication and interpersonal skills.
  • Ability to manage multiple projects and priorities in a fast-paced environment.
  • Certification in quality assurance (e.g., ASQ Certified Quality Manager) is a plus.


What We Offer


  • Salary – from £50,000
  • Agile Working – we offer flexibility and trust from day one, when you attend the office will be guided by business needs and role requirements. This role requires you to work a least two day per week from our Egham, Surrey office or if you are situated in France, two days from a Lyon office, with flexibility for business needs and company events. You must be flexible to travel when required to our CMO partners.
  • £150 towards your home office – claim purchases back on expenses.
  • Healthcare Insurance
  • Pension – you contribute 5% and we offer 3%.
  • Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
  • Enhanced Family Leave
  • Enhanced Sick Pay
  • Annual Leave – 26 days plus bank holidays, 3 days shut down between Christmas and NY.
  • Discretionary Annual Performance Bonus
  • Recognition Program – from shout outs, vouchers and up to £2000 for gold awards


What To Expect


  • We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.
  • Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.
  • Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.

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