Auditor (Regulatory) - Compliance Specialist

2 months ago

Metropolitan Borough of Solihull, United Kingdom Regeneron Pharmaceuticals, Inc Full time

Job Summary:

We are seeking a highly skilled Regulatory Auditor to join our team at Regeneron Pharmaceuticals, Inc. As a key member of our Quality Assurance department, you will be responsible for ensuring that our auditors have the necessary education, experience, and training to perform audits effectively.

Key Responsibilities:

  • Compliance and Regulatory Expertise: Maintain professional expertise and knowledge of audit criteria, including internal company policies and procedures, and applicable local and international regulations, standards, and guidelines.
  • Industry Trend Monitoring: Monitor industry trends with respect to regulatory agency findings, expectations, and warning letters.
  • Process Development and Maintenance: Lead and/or participate in the development and maintenance of department processes and procedures to ensure compliance with current regulatory requirements.
  • Auditor Training and Qualification: Assist management with the maintenance and continuous improvement of the auditor training program, oversight of the training and qualification of auditors, and the development and maintenance of continuing auditor education.
  • Audit Scheduling and Assignments: Assist with audit scheduling and audit assignments as needed.
  • Proxy Auditor Oversight: Assist with the oversight, selection, training, onboarding, and assessment of proxy auditors.
  • Audit Documentation Review: Perform review of audit documentation (audit reports, audit responses, extensions, etc.) for purposes of training, peer review, approval, and/or audit closure.
  • Supplier/External Audits: Perform supplier/external audits and evaluate systems, processes, procedures, and records against applicable GxPs and audit criteria.
  • Collaboration and Communication: Collaborate with Procurement, External Manufacturing, Quality, audit clients, and other stakeholders with respect to supplier/external audits.
  • Training and Development: Perform and maintain all required training and annual GMP training within required timelines.
  • Lead Auditor and Support Auditor Activities: Perform required lead auditor or support auditor activities as applicable for assigned audits.
  • Audit Reporting and Documentation: Prepare written audit reports and documents in accordance with company and department procedures and requirements; ensure the quality and accuracy of all audit documentation; ensure timelines for assigned audits are met.
  • Inspection Readiness and Internal Audits: Participate in IOPS inspection readiness, inspections/partner audits, and internal audits as needed.

Requirements:

  • Education and Experience: BS/BA with 8+ years of related experience in Biotech/Pharmaceutical industry; minimum of 8+ years of Quality Management experience in a GMP environment with prior supplier auditing experience.

Regeneron Pharmaceuticals, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

  • Auditor Regulatory Specialist

    1 month ago

    Metropolitan Borough of Solihull, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Job SummaryRegeneron Pharmaceuticals, Inc is seeking a highly skilled Auditor Regulatory to join our team. As an Auditor Regulatory, you will be responsible for ensuring auditors have the necessary education, experience, and training to perform audits. You will also assist with the maintenance and continuous improvement of the auditor training program.Key...

  • Auditor Regulatory Specialist

    1 month ago

    Metropolitan Borough of Solihull, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Job SummaryRegeneron Pharmaceuticals, Inc is seeking a highly skilled Auditor Regulatory to join our team. As an Auditor Regulatory, you will be responsible for ensuring that our auditors have the necessary education, experience, and training to perform audits effectively. You will also be responsible for planning, coordinating, and performing pre-, during,...

  • Auditor Regulatory Specialist

    1 month ago

    Metropolitan Borough of Solihull, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Job SummaryRegeneron Pharmaceuticals, Inc is seeking a highly skilled Auditor Regulatory to join our team. The successful candidate will be responsible for ensuring auditors have the necessary education, experience, and training to perform audits, and assisting with the maintenance and continuous improvement of the auditor training program.Key...

  • Auditor Regulatory Specialist

    4 weeks ago

    Metropolitan Borough of Solihull, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Job SummaryRegeneron Pharmaceuticals, Inc is seeking a highly skilled Auditor Regulatory to join our team. The successful candidate will be responsible for ensuring auditors have the necessary education, experience, and training to perform audits, and assisting with the maintenance and continuous improvement of the auditor training program.Key...

  • Auditor Regulatory Specialist

    4 weeks ago

    Metropolitan Borough of Solihull, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Job SummaryRegeneron Pharmaceuticals, Inc is seeking a highly skilled Auditor Regulatory to join our team. The successful candidate will be responsible for ensuring auditors have the necessary education, experience, and training to perform audits, and assisting with the maintenance and continuous improvement of the auditor training program.Key...

  • Regulatory Auditor

    2 months ago

    Metropolitan Borough of Solihull, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    Regeneron Pharmaceuticals, Inc is seeking a highly skilled Regulatory Auditor to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring that our auditors have the necessary education, experience, and training to perform audits effectively. Your expertise will be crucial in maintaining and continuously...

  • Regulatory Reporting Specialist

    2 weeks ago

    Metropolitan Borough of Solihull, United Kingdom Paragon Bank Full time

    Regulatory Reporting SpecialistWe are seeking an experienced Regulatory Reporting Specialist to join our team at Paragon Bank. As a key member of our regulatory reporting team, you will be responsible for delivering high-quality regulatory reports and ensuring compliance with emerging good practice and regulatory expectations.Key Responsibilities:Develop and...

  • Auditor Compliance Specialist

    1 week ago

    City Of London, United Kingdom Michael Page (UK) Full time

    About Our ClientMichael Page (UK) is proud to partner with a leading Business Services company in London.Job DescriptionWe are seeking a highly skilled Auditor Compliance Specialist to join our client's Life Sciences team.Key Responsibilities:Conduct regular audits in alignment with GCP standards.Identify areas of non-compliance and suggest improvements.Work...

  • Auditor Compliance Specialist

    3 weeks ago

    City Of London, United Kingdom Michael Page (UK) Full time

    About Our Client Michael Page (UK) is proud to partner with a renowned leader in the Business Services industry, operating from their base in the bustling city of London. This esteemed organization boasts a large team of highly skilled professionals, working tirelessly to provide top-notch Life Sciences services to an array of clients. Job Summary We are...

  • Auditor Compliance Specialist

    3 weeks ago

    City Of London, United Kingdom Michael Page (UK) Full time

    About Our Client Michael Page (UK) is proud to partner with a renowned leader in the Business Services industry, operating from their base in the bustling city of London. This esteemed organization boasts a large team of highly skilled professionals, working tirelessly to provide top-notch Life Sciences services to an array of clients. Job Summary We are...

  • Auditor Compliance Specialist

    2 weeks ago

    City Of London, United Kingdom Michael Page Full time

    p>Are you a detail-oriented and diligent GCP Auditor looking for a new challenge? p>Michael Page is working with a renowned leader in the Business Services industry to find a talented individual to join their Life Sciences team in London. p>As a GCP Auditor, you will be responsible for conducting regular audits in alignment with GCP standards, identifying...

  • Financial Auditor

    4 weeks ago

    City Of London, United Kingdom Laraveldaily Full time

    Job Title: Financial Auditor & Compliance SpecialistLaraveldaily is seeking a highly skilled Financial Auditor & Compliance Specialist to join our team in London. As a key member of our internal audit team, you will be responsible for ensuring the effective implementation of our internal audit program and providing assurance that our financial systems and...

  • Financial Auditor

    4 weeks ago

    City Of London, United Kingdom Laraveldaily Full time

    Job Title: Financial Auditor & Compliance SpecialistLaraveldaily is seeking a highly skilled Financial Auditor & Compliance Specialist to join our team in London. As a key member of our internal audit team, you will be responsible for ensuring the effective implementation of our internal audit program and providing assurance that our financial systems and...

  • Financial Auditor

    1 month ago

    City Of London, United Kingdom Laraveldaily Full time

    Job Title: Financial Auditor & Compliance SpecialistLaraveldaily is seeking a highly skilled Financial Auditor & Compliance Specialist to join our team in London. As a key member of our internal audit team, you will be responsible for ensuring the effective implementation of our internal audit program and providing assurance that our financial systems and...

  • Financial Auditor

    1 month ago

    City Of London, United Kingdom Laraveldaily Full time

    Job Title: Financial Auditor & Compliance SpecialistLaraveldaily is seeking a highly skilled Financial Auditor & Compliance Specialist to join our team in London. As a key member of our internal audit team, you will be responsible for ensuring the effective implementation of our internal audit program and providing assurance that our financial systems and...

  • Auditor Compliance Specialist

    2 weeks ago

    City Of London, United Kingdom Michael Page Full time

    An exciting opportunity has arisen for a diligent and detail-oriented GCP Auditor to join a forward-thinking team in the Life Sciences department in London.About the RoleOur client, a renowned leader in the Business Services industry, is seeking a skilled Auditor to conduct regular audits in alignment with GCP standards.Key ResponsibilitiesConducting regular...

  • Auditor Compliance Specialist

    1 month ago

    City Of London, United Kingdom Michael Page (UK) Full time

    About Our ClientOur client is a leading provider of Business Services, with a strong presence in the Life Sciences sector. Based in London, they offer a range of services to clients across the globe.Job DescriptionWe are seeking a highly skilled Auditor to join our team. As a Compliance Audit Professional, you will be responsible for conducting regular...

  • Auditor Compliance Specialist

    1 month ago

    City Of London, United Kingdom Michael Page (UK) Full time

    About Our ClientOur client is a leading provider of Business Services, with a strong presence in the Life Sciences sector. Based in London, they offer a range of services to clients across the globe.Job DescriptionWe are seeking a highly skilled Auditor to join our team. As a Compliance Audit Professional, you will be responsible for conducting regular...

  • Auditor Compliance Specialist

    4 weeks ago

    City Of London, United Kingdom Michael Page (UK) Full time

    About Our ClientMichael Page (UK) is proud to partner with a leading Business Services company in London, offering a unique opportunity for a skilled Auditor Compliance Audit to join their Life Sciences team.Job DescriptionKey ResponsibilitiesConduct Regular Audits: Ensure compliance with GCP standards by conducting thorough audits, identifying areas of...

  • Auditor Compliance Specialist

    4 weeks ago

    City Of London, United Kingdom Michael Page (UK) Full time

    About Our ClientMichael Page (UK) is proud to partner with a leading Business Services company in London, offering a unique opportunity for a skilled Auditor Compliance Audit to join their Life Sciences team.Job DescriptionKey ResponsibilitiesConduct Regular Audits: Ensure compliance with GCP standards by conducting thorough audits, identifying areas of...