Associate Director, GMP / GDP Compliance

bioM?rieux BV · WorkFromHome, Emilia-Romagna, Italia · · 70€ - 90€

Descrizione dell'offerta

Associate Director, GMP / GDP Compliance

Purpose of the role

Provide strategic compliance leadership to Organon and to Organon’s contract manufacturing operations (CMOs) involved in the manufacture and distribution of active pharmaceutical ingredients (API), biologics, finished pharmaceutical, and medical device products. Support global audits and health authority inspections, ensuring timely and effective implementation of corrective and preventive actions (CAPA) to maintain regulatory compliance.

The position is located in Europe with remote work available.

Main responsibilities

  • Partner with Organon and CMO management to identify, implement, and monitor CAPAs in response to audit and inspection findings; independently verify CAPA effectiveness and closure.
  • Support inspection readiness across Organon sites and functions; participate in audits and inspections to ensure successful outcomes.
  • Draft and review health authority correspondence, ensuring clarity, accuracy, and alignment with regulatory expectations.
  • Serve as a subject matter expert on current good manufacturing practice (CGMP) and good distribution practice (GDP) requirements for pharmaceutical, biopharmaceutical, and medical device products.
  • Gather and analyze internal audit findings and external regulatory intelligence to identify new and emerging trends; communicate insights to senior leadership.
  • Author and review global standards and procedures to ensure alignment with evolving regulatory requirements.
  • Actively participate in industry organizations (e.g., PDA, ISPE, BioPhorum) to stay current on regulatory trends and to benchmark inspection approaches.

Required qualifications

  • Minimum of 10 years in quality, operations, or technical roles within the pharmaceutical, biopharmaceutical, vaccine, or medical device industries.
  • Demonstrated expert-level knowledge of pharmaceutical GMP / GDP regulations across multiple international regulatory authorities (e.g., FDA, EMA, MHRA).
  • Proven ability to interpret and apply regulatory expectations to build and sustain a robust and compliant quality management system.
  • Demonstrated leadership in navigating complex issues by integrating diverse viewpoints, making independent decisions, and advocating for evidence-based compliance positions with integrity.
  • Experienced in fostering alignment across teams with varied perspectives to drive consensus and achieve common objectives, with a strong sense of accountability and escalation when needed.
  • Willing and able to travel up to 10% of the time.

    • Highly desired qualifications

  • Minimum of 5 years of direct experience of GMP audits or inspections, either from working for a health authority or managing health authority inspections.
  • Strong technical and regulatory knowledge in aseptic manufacturing, preferably with hands-on experience.
  • Familiarity with medical device standards and GMP requirements (e.g., ISO 13485, EU MDR).

    • Secondary Job Description

    Who We Are :

    Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear : A better and healthier every day for every woman.

    As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

    Search Firm Representatives Please Read Carefully

    Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    Annualized Salary Range

    Annualized Salary Range (Global)

    Annualized Salary Range (Canada)

    Please Note : Pay ranges are specific to local market and therefore vary from country to country.

    Employee Status : Regular

    Relocation : No relocation

    VISA Sponsorship :

    Travel Requirements : Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

    Flexible Work Arrangements :

    Shift :

    Valid Driving License :

    Number of Openings :

    Requisition ID : R533177

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