Location: Hybrid in Slough with 3 days in the office
Company: A global Pharmaceutical Company
Senior Quality Specialist
The Senior Process Quality Excellence Specialist will assist the Head of Process Quality Excellence in developing and sustaining clinical quality systems and procedures, while ensuring that quality and compliance risks are effectively identified and addressed. This role encompasses all aspects of clinical studies managed by Global Clinical Sciences and Operations (GCSO), with a strong emphasis on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Pharmacovigilance (PV) regulations and guidelines.
Key Responsibilities:
* Contribute to the development of quality and compliance infrastructure within GCSO, including drafting and revising policies, Standard Operating Procedures (SOPs), processes, and best practices.
* Collaborate with teams across Global Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure alignment with ICH GCP, GLP, PV standards and applicable local and international regulations, maintaining inspection readiness.
* Lead inspection readiness initiatives across GCSO functions, working closely with designated inspection teams.
* Participate in audit and inspection planning in coordination with Global Quality.
* Ensure GCSO representation and preparedness during internal and external audits and inspections.
* Provide support to GCSO personnel in developing responses to audit and inspection findings.
Qualifications:
* Minimum of 8 years’ experience in the pharmaceutical industry within global Quality Assurance.
* Extensive knowledge of GCP and GVP, with practical experience in conducting global audits and inspections.
* At least 2 years of experience in SOP development and writing.