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Austin Fraser
,
London, Greater London
Associate Director, Global GMP Compliance
Overview
Job Description
In this role you will plan and execute a program of corporate GMP compliance audits/assessments for GMP sites and operations with a focus on sterile and non-sterile drug products (including cell and gene therapy, biologics, oral dosage forms), biological and chemical APIs, medical devices and excipients but also covering food, feed and dietary supplements. Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and company expectations and requirements. You will advise, guide and support sites in the overall regulatory inspection management. Provide expertise to sites and the global organization on GMP compliance and best practices as well as new and developing GMP regulatory requirements and trends - The role will involve a large amount of international travel (up to 50%). Key responsibilities: Global GMP Compliance Audit/Assessment Management * Develop audit plans/agendas for corporate GMP compliance assessments/audits based on risk * Execute corporate GMP compliance audits/assessments (as lead or co-assessor/auditor) * Communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads Regulatory Inspection Management * Conduct pre-approval/pre-submission project reviews (e.g. products, facilities), "mock" inspections as part of the Global GMP Compliance Assessment program. * Provide guidance for timely remediation, advise, guide and support sites in the overall regulatory inspection management * In cooperation with other Global Quality functions, review and provide input to responses following regulatory inspections GMP Compliance Risk Management * Perform regular analysis of regulatory observations made at company sites, prepare and coordinate the global follow-up/gap analysis to prevent re-occurrence and provide advice to the sites * Provide expertise to sites and the organization on new and developing GMP regulatory requirements and trends, to help ensure the company remains up-to-date with current GMP * Lead or participate in the continuous improvement and maintenance of a global platform for reporting, reviewing and trending GMP Compliance risks on a global basis Quality/Compliance projects and standards * Participate in or lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives * Fulfil role as a compliance reviewer and approver of CORP and GROUP GMP procedures and policies * Develop and maintain CORP and GROUP Quality standards and processes based on expertise and assigned areas and ensure expertise in GMP is kept current through involvement in Industry forums and conferences You will be rewarded with a fantastic salary and benefits including bonus, pension, and healthcare. Austin Fraser is acting as an Employment Agency in relation to this vacancy. Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status. Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.