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Lead GxP Specialist
2 months ago
Blackfield Associates are currently supporting a leading clinical-stage biopharmaceutical in their search to find a remote Lead/Principal GxP Specialist.
As the Lead/Principal GxP Specialist, you will be responsible for overseeing the Electronic Quality Management Systems (eQMS) to ensure regulatory compliance and effective system management. You will lead a team, manage the Veeva QualityDocs Vault and QMS Vault, and collaborate with business functions to identify and address process gaps. Other responsibilities include:
- Lead and support the Quality Management Systems team, ensuring eQMS systems are managed within a controlled, traceable, and auditable GxP environment.
- Oversee Veeva platform management, including proactive project planning, system upgrades, and day-to-day support, while ensuring data integrity and compliance.
- Partner with business functions to identify process gaps, recommend solutions and drive continuous improvement of the QMS system.
- Contribute to and execute the eQMS business roadmap, ensuring alignment with organizational goals, and provide metrics and insights at quality review meetings.
The ideal candidate will have at least 5 years of experience in a regulated environment with routine interaction with eQMS or e-documentation management systems, ideally within the Pharmaceutical or biotechnology sectors. Experience with the Veeva platform and MHRA inspections is essential. A strong business acumen, advanced communication skills, and a proven ability to manage external partner relationships and projects in a fast-paced environment are also crucial.
