Senior QA IT Audit Project Manager

Vor 7 Tagen

Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland AbbVie Vollzeit
About the Role

We are seeking a highly skilled Senior QA IT Audit Project Manager to join our team at AbbVie. As a key member of our quality assurance team, you will be responsible for managing GxP IT inspection activities to ensure compliance with policies, procedures, and applicable government regulations.

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.
  • Lead GxP IT Supplier Audits to ensure suppliers have management systems in place to ensure compliant/repeatable products/services.
Requirements
  • Bachelor's degree in physical science, life science, or pharmacy, with a strong technical background.
  • Accreditation by a professional body, such as ASQ, desirable.
  • Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory, or Validation background in a regulated industry required.
  • 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 manage sensitive proprietary information.
  • Strong project management skills and excellent oral and written communication skills.
  • Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment, and the ability to make difficult decisions.
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.
  • A corporate health management that offers 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.
About AbbVie

We are a global biopharmaceutical company with a commitment to equality, equity, diversity, and inclusion. We strive to create an inclusive culture where all employees can thrive and reach their full potential. We believe that diversity and inclusion are essential to our success and are committed to creating a workplace where everyone feels valued, respected, and empowered to contribute their best work.

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