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Senior QA IT Audit Project Manager
vor 3 Monaten
People. Passion. Possibilities. Three words that make a world of difference.
More than a job. It's a chance to make a real difference.
Welcome to AbbVie As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place
Together, we break through – as Senior QA IT Audit Project Manager (all genders) permanent / full-time - in Ludwigshafen
Make your mark:
- Manage GxP IT inspection activities to assure that AbbVie's quality system, and its GxP IT Systems that support manufacturing facilities, testing programs, clinical/pre-clinical study conduct, personnel, and records in support of worldwide regulatory filings are able to demonstrate compliance to policies, procedures and applicable government regulations.
- Influence and train inspection preparation teams comprised of a variety of technical experts.
- Coordinate GxP pre-approval inspection preparation activities for contract facilities utilized in support of regulatory filings.
- Strategize corrective action plans and provide compliance support during implementation to ensure successful inspections.
- Effectively communicate risks to management, both orally and in writing.
- Quality Systems: Provide guidance and interpretation of Affiliate QA Policies and Procedures based on applicable requirements/regulations.
- Management of the global AbbVie's GxP IT System self-inspection program including organization of the global, internal audit schedule In some U.S. manufacturing sites
- Lead GxP IT Supplier Audits to ensure AbbVie's suppliers providing GxP IT products and/or supporting services have management systems in place to ensure compliant/repeatable product/service(s).
Qualifikationen
This is how you can make a difference:
- Bachelor’s degree, preferably in physical science (e.g. Chemistry) life science (e.g. microbiology or biology) or pharmacy. Strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized technical fields.
- Accreditation by a professional body desirable. Examples include American Society for Quality
- (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 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, documented understanding/knowledge of international GXP regulations.
- Knowledge of pharmaceutical drug development and clinical research processes.
- Regulatory inspection experience preferably with direct agency inspector interaction.
- Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
- Strong project management skills are essential.
- Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
- 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, often at short notice.
What we offer you:
- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network
Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are 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.
Zusätzliche Informationen
Nur gemeinsam können wir das Beste für Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion. Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten können – unabhängig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen. Doch für uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu berücksichtigen: Sie bezieht sich auch auf unterschiedliche Ausbildungshintergründe, Fachkenntnisse, Persönlichkeitstypen, Denkweisen und Lebenserfahrungen.
