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Quality System Manager
2 months ago
Essential Pharma are looking for a Quality Systems Manager to deliver the globalisation of QA processes, implement and embed a new quality system and ensure deep collaboration across all teams in the UK, Switzerland and Malta to ensure we can progress with a “one team” mindset. Apply Today
What You Will Do
- Lead a small team, reporting into the Head of QA, ensuring a collaborative approach to new ways of working and engagement of all teams to ensure a “one team” mindset.
- Deliver the new QMS for Essential, retaining oversight of quality systems processes, maintenance and ensuring that we are audit ready.
- Collaborate with the QA team to manage processes related to QA documentation (GMP, GDP, GCP/GVP), deviations, complaints, CAPAs and change controls.
- Own reporting against KPIs and once live, lead on the administration of the EDMS database (including user training, configuration and withdrawal).
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
- QMS knowledge (Veeva or similar) gained in a project based or management roles where you have implemented or acted as a key contributor to the implementation of new systems and led change management in relation to quality processes.
- GxP knowledge gained working in a pharmaceutical setting, with exposure to US and EEA regulations.
- Eligibility to live and work in the UK.
What We Offer
- Salary – from £65,000.
- 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 two days a week from our Egham, Surrey office with flexibility on start/ends times.
- £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.
