Senior Process Quality Excellence Specialist

Advanced Resource Managers Ltd; Slough; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Process Quality Excellence Specialist to enhance its clinical quality systems. Ideal candidates will have over 8 years in pharmaceutical quality assurance, strong knowledge of GCP and GLP, and expertise in SOP writing. This contract position offers a hybrid work model and is located in Slough, England.

Qualifications

• 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.

Responsibilities

• Support the Head with quality and compliance infrastructure development.
• Work in collaboration with Global Quality and other stakeholders to ensure compliance.
• Lead and drive inspection readiness activities across functions.
• Participate in audit and inspection planning with global quality.
• Ensure representation during audits/inspections.

Skills

GCP

GLP

PV regulations

SOP writing

Audit experience

Job description

About the role

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.