QA Manager, Clinical Development

Chemidex Pharma Limited; Egham; Hybrid; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Clinical Development QA Manager to ensure compliance with GxP standards across clinical studies. This pivotal role involves maintaining quality strategies, coordinating audits, and driving CAPA activities to support clinical development. As part of a dynamic team, you will contribute to the oversight of quality systems and regulatory inspections, ensuring that the organization adheres to the highest standards of quality and compliance. If you have a passion for quality assurance and a commitment to excellence, this opportunity offers a chance to make a significant impact in a growing pharmaceutical company.

Benefits

Hybrid Working

£150 towards home office

5% Pension contribution

Life Insurance

Enhanced Family Leave

Enhanced Sick Pay

26 days Annual Leave

Discretionary Annual Performance Bonus

Qualifications

• 5+ years of GCP QA experience with knowledge of GMP.
• Experience in building and maintaining a Quality Management System.

Responsibilities

• Maintain quality strategy for Clinical Development activities.
• Coordinate audits of clinical sites and manufacturers.
• Drive Corrective and Preventive Action (CAPA) activities.

Skills

GCP

GMP

GLP

Quality Management System

Pharmacovigilance

Education

Life science degree (Biotechnology, Pharmacy, Chemistry)

Job description

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Clinical Development QA Manager

Essential Pharma are looking for a Clinical Development QA Manager who will be focusing on identifying and mitigating quality and compliance risks related to all aspects of clinical studies, adhering to Good Clinical Practice (GCP), Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), Good Manufacturing Practice (GMP), Good Distribution Practices (GDP) for clinical trial supplies and Good Pharmacovigilance Practices (GPvP) regulations and guidance, as well as leading internal site audits and external regulatory inspections. Apply today!

What You Will Do

• Maintain quality strategy, which is in line and suitable for the business needs relating to Clinical Development activities.
• Maintain a quality system in line with business needs. This will include, but is not limited to:
• Develop and maintain a quality management System to support the clinical development activities within the pre-commercial business unit.
• Drive the development and issuance of the necessary SOPs to cover best practices that supports clinical trial activities and processes in a timely manner.
• Provide support for GCP, which will include co-ordination of audits of clinical sites, CROs and internal processes and relevant clinical documentation as required.
• Provide support for GMP, which will include co-ordination of audits of manufacturers and suppliers as required.
• Provide support for GLP, which will include co-ordination of audits of laboratories as required.
• Drive and maintain the annual audit schedule for internal and external audits and support with a CAPA system to track and close out any audit findings
• Preparation and review of documentation required for regulatory submissions.
• Development, tracking and maintenance of general quality procedures for staff and consultant training (training matrix) and outsourced resource.
• Documentation release and control oversight and management.
• Pharmacovigilance Quality Assurance
• Provide appropriate training as required across all clinical drug development phases
• Drive and maintain a state of regulatory inspection readiness.
• Collaborate with Clinical Development Project team, and other stakeholders to ensure continued compliance with ICH guidance including but not limited to GCP, PV, and relevant local and international regulations.
• Provide regular reports to Senior Management on Quality updates.
• Stay updated on regulatory trends and share key insights within the organization.
• Drive and maintain Corrective and Preventive Action (CAPA) activities, including tracking and monitoring for timely closure.
• Maintain an up-to-date overall awareness of relevant regulatory guidelines and current trends in GCP/GLP/ GCLP/ GMP/ for territories in where clinical trial activities will be performed to support clinical studies/ clinical manufacture.

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 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.

In December 2024, Essential Pharma announced a €900 million recapitalisation with partners Gyrus Capital, welcoming AlpInvest and new strategic financing from Sixth Street.

Our business is comprised of around 70 people based out of our offices in Surrey UK, Malta, France, Spain and Switzerland.

What You Will Bring

• Life science degree, such as biotechnology, life sciences, pharmacy, chemistry or other equivalent relevant qualification required.
• Minimum 5 years GcP QA experience together with a thorough knowledge of GmP and the interaction between the two.
• Have managed or been involved in the building and maintenance of a Quality Management System to support clinical trials within a small to mid-size Biotech company.
• Previous significant experience in equivalent roles, such as a pharmaceutical quality assurance role within a clinical development setting such as a CRO or a sponsor of clinical trials
• In depth knowledge and understanding of GxP where GCP, is key with other GXPs are also ideal GMP, GP

What We Offer

• Hybrid Working: We offer flexibility and trust from day one, with a balance of remote and office-based work. We understand that different roles have different requirements and are committed to providing additional flexibility as needed. This will be discussed during the initial interview process.
• £150 towards your home office – claim purchases back on expenses.
• Pension – you contribute 5% and we offer 5%.
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
• Enhanced Family Leave
• Enhanced Sick Pay
• Annual Leave – 26 days
• Discretionary Annual Performance Bonus

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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