Are you ready to shape quality strategy across global clinical development programmes and ensure excellence in GCP compliance from study start to inspection readiness?
Proclinical is seeking a Senior Manager, GCP QA Operations to join a dynamic team in London. You will serve as a key quality representative, collaborating with a broad range of stakeholders to promote compliant clinical operations and drive quality-focused decision making across development programmes. The successful candidate will provide expert quality guidance to stakeholders involved in clinical research activities, supporting regulatory compliance and adherence to established industry standards. This role is well suited to a proactive professional who enjoys working across multiple functions and contributing to high-quality research outcomes.
Responsibilities
- Ensure compliance with GCP and relevant regulatory requirements for assigned clinical studies and programs.
- Provide quality oversight and ensure consistency in operational methodologies and processes.
- Act as a key partner to cross-functional study teams, offering quality assurance expertise and guidance.
- Monitor quality performance, identify areas for improvement, and promote best practices.
- Review quality agreements and contracts with clinical vendors and partners to ensure compliance.
- Support the preparation and execution of clinical quality plans and risk-based approaches. Contribute to inspection readiness activities and provide support during GCP inspections.
- Collaborate with internal and external stakeholders to address compliance issues and implement corrective actions.
- Facilitate the implementation and continuous improvement of clinical and medical quality systems.
- Conduct risk assessments and manage quality events, investigations, and CAPA (Corrective and Preventive Actions).
- Develop and communicate corporate quality objectives related to clinical research.
- Promote a culture of continuous process improvement and quality risk management.
Key Skills and Requirements
- Strong knowledge of GCP, Good Pharmacovigilance Practices (GVP), and Good Pharmacoepidemiology Practices (GPP).
- Experience in managing interventional and non-interventional clinical studies.
- Proven ability to analyze complex problems and develop effective solutions.
- Excellent interpersonal, leadership, and collaboration skills, with the ability to work in a matrix organization.
- Strong customer focus and ability to influence cross-functional teams.
- Proficiency in English (written and spoken).
- A Master's degree or higher in a relevant scientific field is essential; a degree in Quality or a PhD is preferred.
- Willingness to travel up to 20% of the time.
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Senior Manager, GCP QA Operations employer: Proclinical Staffing
Join a dynamic and innovative team as a Downstream Scientist, where you'll have the opportunity to contribute to cutting-edge biopharmaceutical and vaccine development in a collaborative environment. Our company fosters a culture of continuous learning and professional growth, providing early-career scientists with hands-on experience and mentorship from seasoned professionals. Located in a state-of-the-art facility, we prioritise employee well-being and offer a supportive atmosphere that encourages creativity and excellence in scientific research.
