Quality Assurance Director for Pharmaceutical Organisation

1 week ago


London, Greater London, United Kingdom Clinical Professionals Limited Full time

Clinical Professionals Limited is seeking an experienced Associate Director to lead the Clinical Quality Assurance (CQA) team in EMEA.

Job Summary:

The ideal candidate will have a strong background in GCP compliance and regulatory inspections, with experience in managing quality documentation and collaborating with cross-functional teams. As the GCP Subject Matter Expert (SME), you will ensure adherence to ICH E6 guidelines and mentor staff to enhance quality and auditing skills.

About the Role:

  • Act as GCP and EMEA regulation SME, contributing to a risk-based, scientifically-driven quality system.
  • Lead the assessment and approval of vendors for potential use, offering guidance and oversight to ensure alignment with company quality and compliance standards.
  • Collaborate cross-functionally to address and mitigate GCP quality and compliance issues.
  • Ensure adherence to the ICH E6 Guideline for Good Clinical Practice and mentor staff to enhance quality and auditing skills.
  • Manage quality documentation in Veeva QMS and Vault.
  • Represent the company in regulatory inspections.

Requirements:

We are looking for a highly skilled professional with:

A Bachelor's degree in Biology, Chemistry, or related life sciences with at least 7-10 years of experience, or an advanced degree (MS, PhD, MBA) preferred with additional equivalent experience.Experience with managing regulatory inspections, collaborating with regulators and internal staff for inspection preparation.Experience with SOP development relevant to clinical, regulatory and medical processes.Proficient in GCP and EU clinical regulations, and risk-based quality systems aligned with ICH E6.Extensive knowledge of Phases I-IV (especially Phase III), with preference for regulatory approval, NDAs, and MAAs experience.Able to travel domestically and internationally (25-30%).

Salary: €90,000 - €110,000 per annum, depending on experience, plus benefits.

Location: Central London / West End



  • London, Greater London, United Kingdom CatSci Ltd. Full time

    Job SummaryThe Pharmaceutical Quality Assurance Specialist will be responsible for ensuring the effective administration, monitoring, and completion of the Pharmaceutical Quality System. This includes reviewing and approving Site Policies, SOPs, Work Instructions, logs, and forms, as well as ensuring compliance to those procedures.Key ResponsibilitiesProvide...


  • London, Greater London, United Kingdom Cypartners Full time

    Quality Assurance Officer - Entry Level in North London. Salary: Up to £27,000 + shift allowance + bonus. CY Partners is seeking a detail-oriented and personable Quality Assurance Officer to join their team in London. Key responsibilities include reviewing pharmaceutical batch manufacturing records for compliance with Good Manufacturing Practice (GMP) / GxP...


  • London, Greater London, United Kingdom Cypartners Full time

    Quality Assurance Role - PharmaceuticalsLocation: North LondonContract: PermanentSalary: up to £28,000 + shift allowance + bonusShift Based (Mon-Fri)Do you have experience reviewing documentation compliant with Good Manufacturing Practice (GMP) / GxP?Would you like to work for a reputable scientific organisation, making a direct difference to patients'...


  • London, Greater London, United Kingdom CatSci Ltd. Full time

    The CatSci Ltd. team is seeking a skilled Pharmaceutical Quality Assurance Specialist to ensure the effective administration, monitoring, and completion of the Pharmaceutical Quality System.This role will involve reviewing and approving Site Policies, SOPs, Work Instructions, logs, and forms to ensure compliance with procedures.Key Responsibilities:Provide...


  • London, Greater London, United Kingdom Hyper Recruitment Solutions Ltd Full time

    We're seeking a Quality Assurance Manager to join our team at Hyper Recruitment Solutions Ltd. Based in the Surrey region, this leading Specialist Pharmaceutical business is looking for an experienced QA professional.**Key Responsibilities:**To lead the Site Management Team, representing the interests of the QA department.**Requirements:A strong background...


  • London, Greater London, United Kingdom Hyper Recruitment Solutions Ltd Full time

    We are seeking a highly experienced Director of Pharmaceutical Operations to lead our quality assurance and compliance efforts.As the Director of Pharmaceutical Operations, you will be responsible for providing strategic direction and oversight for the formulation and process development activities of our products.You will work closely with cross-functional...


  • London, Greater London, United Kingdom Hobson Prior International Ltd Full time

    Job Description:We are seeking a Pharmaceutical Quality Assurance Manager to join our team at Hobson Prior International Ltd.About the Role:This is an exciting opportunity for a seasoned quality assurance professional to lead and manage internal audits, ensuring compliance with regulatory requirements and improving operational performance.The successful...


  • London, Greater London, United Kingdom Consult Search & Selection Full time

    Job DescriptionWe are seeking a highly experienced Senior Pharmaceutical Quality Director to join our client, a leading global specialist in pharmaceuticals, committed to delivering high-quality products.The ideal candidate will have extensive experience in pharmaceutical quality, including audit, batch record review, change control, complaint handling, and...


  • London, Greater London, United Kingdom Quality Assurance Agency Full time

    Job DescriptionWe are seeking a Customer Engagement Director to join our team at Quality Assurance Agency. In this role, you will be responsible for establishing, maintaining, and measuring the success of commercial partnerships.You will work closely with the Customer Engagement team to identify opportunities and develop proposals that build value and...


  • London, Greater London, United Kingdom CatSci Full time

    About the RoleWe are seeking an experienced Quality Assurance Specialist to join our team at CatSci Ltd. This role offers a unique opportunity to work in a dynamic environment where you will be responsible for ensuring compliance with regulatory guidelines and industry standards.Job Summary:The successful candidate will have a degree in a relevant field (or...


  • London, Greater London, United Kingdom Arthur Edward Full time

    About the RoleWe are seeking a seasoned Senior Quality Assurance Manager to join our team at Arthur Edward. As a key member of our quality assurance function, you will be responsible for ensuring the highest standards of quality in our pharmaceutical manufacturing operations.Key Responsibilities:Develop and implement quality management systems, procedures,...


  • London, Greater London, United Kingdom NOVUMGEN Full time

    At Novumgen, we are committed to delivering life-changing medicines that contribute safety and value to patients, healthcare institutions, and prescribers across the globe.We are currently seeking a Director of Pharmaceutical Quality Management to join our team. This role requires excellent knowledge and communication skills to ensure a smooth operation.The...


  • London, Greater London, United Kingdom Quality Enterprises USA Full time

    At Quality Enterprises USA, we are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong understanding of regulatory requirements and industry standards, as well as excellent problem-solving and analytical skills.Responsibilities:Proficiency in root cause analysis techniques and CAPA managementStrong...


  • London, Greater London, United Kingdom Hyper Recruitment Solutions Full time

    We are seeking a seasoned Quality Director to lead our global quality initiatives and ensure compliance with regulatory requirements in the UK, EU, and international markets.About the Role:The successful candidate will oversee the global Quality, Technical, and Compliance teams, managing Qualified Persons (QPs) and product certification across multiple...


  • London, Greater London, United Kingdom Network Scientific Ltd. Full time

    We are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team at Network Scientific Ltd. The successful candidate will be responsible for ensuring the quality and safety of our sterile products, working closely with our manufacturing team to ensure compliance with regulatory requirements.Key Responsibilities:Ensure that testing...


  • London, Greater London, United Kingdom Barrington James Full time

    Job Title: Director of Quality AssuranceWe are seeking an experienced Director of Quality to lead our team of quality professionals in upholding excellence across all quality operations. Our organisation is committed to maintaining the highest standards in quality management, compliance, and continuous improvement. This role offers the flexibility of remote...


  • London, Greater London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

    Job DescriptionJob Summary:Guy's and St Thomas' NHS Foundation Trust is seeking an experienced Pharmaceutical Quality Assurance Specialist to join our Quality Team. The successful candidate will be responsible for maintaining the integrated Quality Systems across the Pharmacy Manufacturing Service, ensuring compliance with GMP and MA(IMP) licences, and...


  • London, Greater London, United Kingdom Organon Full time

    Organon is a leading pharmaceutical company that prioritizes product quality and patient safety. We are seeking an experienced Director of Product Quality Assurance for Women's Health to join our team.


  • London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Job Title: Senior Director, Quality AssuranceJob Summary:We are seeking an experienced Senior Director, Quality Assurance to lead our GCP inspection readiness efforts. The successful candidate will be responsible for managing inspection logistics, process improvements, and ensuring compliance with regulatory requirements.Key Responsibilities:Supervising and...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Senior Director, Quality Assurance and ComplianceCpl Healthcare is seeking an experienced Senior Director, Quality Assurance and Compliance to lead our global quality and compliance initiatives. The successful candidate will be responsible for ensuring that our company's quality management systems are in place and functioning effectively.Key...