Senior Quality Assurance IT Audit Project Manager
vor 4 Wochen
At AbbVie, we're committed to making a difference in the lives of patients worldwide. As a Senior QA IT Audit Project Manager, you'll play a critical role in ensuring the quality and integrity of our IT systems, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Manage GxP IT inspection activities to ensure compliance with policies, procedures, and applicable government regulations.
- Influence and train inspection preparation teams comprised of technical experts.
- Coordinate GxP pre-approval inspection preparation activities for contract facilities.
- Strategize corrective action plans and provide compliance support during implementation.
- Effectively communicate risks to management, both orally and in writing.
- Provide guidance and interpretation of Affiliate QA Policies and Procedures based on applicable requirements/regulations.
- Manage the global AbbVie's GxP IT System self-inspection program, including organization of the global, internal audit schedule.
- Lead GxP IT Supplier Audits to ensure AbbVie's suppliers have management systems in place to ensure compliant/repeatable product/service(s).
Requirements:
- Bachelor's degree in a relevant field, such as physical science, life science, or pharmacy.
- Accreditation by a professional body, such as ASQ Certified Quality Manager (CQM) or Project Management Professional (PMP) Certification.
- Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory, or Validation background in a regulated industry.
- Experience in two or more of the following areas: Clinical Operations, Pharmacovigilance, manufacturing/testing of sterile dosage forms, biologics, liquids, solid dosages, active pharmaceutical ingredients, or medical devices.
- Thorough understanding/knowledge of international GXP regulations.
- Knowledge of pharmaceutical drug development and clinical research processes.
- Regulatory inspection experience, preferably with direct agency inspector interaction.
- Ability to anticipate and manage the sensitive nature of proprietary information.
- Strong project management skills and excellent oral and written communication skills in German and English.
What We Offer:
- A diverse work environment where you can have a real impact.
- An open corporate culture.
- An attractive salary.
- An intensive onboarding process with a mentor at your side.
- Flexible work models for a healthy work-life balance.
- Corporate health management with comprehensive health and exercise programs.
- Company social benefits.
- A wide range of career opportunities in an international organization.
- Top-tier, attractive development opportunities.
- A strong international network.
At AbbVie, we're committed to equality, equity, diversity, and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture, and treating all employees with dignity and respect.
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