Senior Process Quality Excellence Specialist
Posted 1 week ago by Serocor
Negotiable
Inside
Hybrid
Slough, England, United Kingdom
Summary: The role of Senior Process Quality Excellence Specialist involves supporting the Head of Process Quality Excellence in a leading biopharmaceutical company based in Berkshire. The position requires extensive experience in quality assurance within a pharmaceutical or clinical development context, focusing on GCP, GLP, and PV regulations. This contract role is offered on a hybrid basis and is classified as inside IR35. The successful candidate will play a key role in developing quality systems and ensuring compliance with relevant regulations.
Key Responsibilities:
- Support the Head with quality and compliance infrastructure development.
- Assist with creation/revision of quality and compliance policies, SOPs, processes, and best practices.
- Collaborate with Global Quality, Patient Safety, Regulatory Affairs, and other stakeholders to ensure compliance with ICH, GCP, GLP, PV, and relevant regulations.
- Lead and drive inspection readiness activities across functions.
- Participate in audit and inspection planning with global quality.
- Represent or ensure representation during audits/inspections by internal and external parties.
- Support staff with audit/inspection responses as required.
Key Skills:
- 8+ years of pharmaceutical experience, preferably in global quality assurance or clinical development.
- In-depth experience of GCP and GVP, including hands-on experience in global GCP audits and/or inspections.
- 2+ years of experience in SOP writing.
Salary (Rate): undetermined
City: Slough
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: Senior
Industry: Other
Are you an experienced Quality Assurance professional? Do you have a background in a Pharmaceutical or Clinical Development setting? If so, this could be the perfect opportunity for you! We are recruiting for a Senior Process Quality Excellence Specialist to join a leading multinational biopharmaceutical client based in Berkshire. The successful candidate will support the Head of Process Quality Excellence in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated. Candidates will need experience and focus on GCP, GLP and PV regulations and guidance. This is a contract position, inside IR35, offered initially for 12 months on a hybrid basis.
Responsibilities:
- Support the Head with quality and compliance infrastructure development, assist with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed.
- Work in collaboration with Global Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with International Council for Harmonization of Technical Requirements for ICH, GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.
- Lead and drive inspection readiness activities across functions working closely with the relevant inspection teams.
- Participate in audit and inspection planning with global quality.
- Represent or ensure representation including preparation during audits/inspections / on-site by internal and external parties.
- Support staff with audit/inspection responses, where required.
Requirements:
- 8+ years of pharmaceutical experience, preferably in a global quality assurance or a clinical development setting.
- In depth experience of GCP and GVP, including hands on experience in global GCP audits and/or inspections.
- 2+ years of experience in SOP writing essential.