AX-7108 Senior Manager, GMP Audit
This key position will have responsibility for directing and executing the quality agreement and audit programs for manufacturing plants and affiliates (20+) in the EMEA region for this global pharmaceutical company.
Global organisation – top 20 pharma
Excellent career development opportunities
Fantastic, modern offices
domestic and international travel
Manages internal audit program of company entities within the EMEA region and identifies / evaluates all potential compliance issues. Prepares and distributes formal reports in a timely manner. Updates related databases in a timely manner and generates status reports as required.
Conducts cGMP audits of suppliers in support of the supplier evaluation program, including company manufacturing plants, affiliates, third party manufacturers and LSPs.
Leads the development and distribution of formal reports to Management as required.
Oversees the quality agreement program including inter-company and external quality agreements that define specific parameters for a project and with party is responsible for execution.
Collaborates with Supply Chain, Purchasing, Legal and other members of QA to maintain a list of approved suppliers and quality agreements.
Oversees the development and implementation of the quality agreement program of company entities within the EMEA region. Ensures quality agreements are initiated and maintained in compliance with changing industry regulations.
Engages with stakeholders both internal and external to the company to ensure quality agreements are complaint with industry regulations.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Bachelor’s Degree, typically in a scientific discipline.
In-depth knowledge of cGMP and for EMEA, with a broad knowledge of quality principles and industry trends.
Extensive cGMP auditing experience required
Experience in a electronic quality management system i.e. Trackwise, QPulse
Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.
Experience within Steriles or solid dosage manufacturing, ideally both
Ability to apply industry knowledge and interpretation to anticipate global impact and contribute ideas for strategies and levels of management. Ability to develop and maintain effective relationships with internal and external stakeholders including Global company entities.
Must be a self-starter, proactive and have the ability to manage department resources to achieve desired outputs. Demonstrated experience in developing / executing quality strategies with a pragmatic approach to decision-making.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.
To apply, please click APPLY ONLINE.
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