We are seeking an experienced Senior Process Quality Excellence Specialist to support the development, implementation, and maintenance of clinical quality systems within Global Clinical Sciences & Operations. This role ensures that quality and compliance risks are proactively identified and mitigated across clinical study activities, with a strong focus on GCP, GLP, and Pharmacovigilance regulations.
Key Responsibilities:
* Support the development and maintenance of quality and compliance infrastructure, including drafting, revising, and implementing policies, SOPs, processes, and best practices.
* Collaborate with cross-functional teams, including Global Quality, Patient Safety, Regulatory Affairs, and strategic partners, to ensure adherence to GCP, GLP, PV, and applicable regulations.
* Lead inspection readiness activities across all functions, working closely with inspection teams.
* Participate in audit and inspection planning and provide support during preparation and on-site inspections.
* Assist staff with audit and inspection responses as needed.
Qualifications & Requirements:
* 8+ years of pharmaceutical experience, ideally in global Quality Assurance or Clinical Development.
* Extensive knowledge of GCP and GVP, with hands-on experience in global audits and/or inspections.
* Minimum 2 years of experience in SOP creation and management.
* Strong communication, collaboration, and organizational skills, with the ability to manage multiple priorities across functions.
This is a fantastic opportunity to join a world-leading pharmaceutical organisation, shape global clinical quality systems, and drive excellence and compliance across multiple functions
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com