Associate Director, Global GMP Compliance

Associate Director, Global GMP Compliance

Lonza

Basel, Bornem or Slough

In this role you will plan and execute a program of corporate GMP (Good Manufacturing Practice) compliance audits/assessments for Lonza’s 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 Lonza 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 Lonza’s 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.

Key requirements:

  • MSc in biochemistry/biologics, chemistry, pharmacy or equivalent;
  • Excellent knowledge of and working experience with international GMP regulations and guidelines especially US/EU for Drug Products including aseptic manufacturing, APIs (biotechnology derived: cell culture/fermentation and chemical) medical devices, and excipients. Experience in Cell and Gene Therapy is beneficial;
  • Extensive experience as a GMP auditor and in regulatory inspection management incl. USFDA;
  • Thorough operational experience in Quality Assurance/Quality Management for Drug Products and biological, chemical APIs;
  • Proven experience in compliance related remediation, working knowledge of the GMP quality management concepts, risk management techniques;
  • Excellent oral and written English communication skills plus preferably other languages;
  • Experience in Data Integrity and CSV (advantageous);
  • Experience in pharma/biotech operations (advantageous);
  • Prior experience as a regulator is beneficial.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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