Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Further develop your expertise and join our team as Associate Director (all genders), GLP and Early Development Quality Assurance (permanent / fulltime).
Primarily responsible for ensuring adherence to GLP as well as GCP laboratories regulations and to assist in developing an organizational model for the Preclinical Quality Assurance Unit. Manage a team of audit professionals with principal responsibility for quality oversight of GLP and GCP regulated study activities.
This means:
- Management of the GLP Quality Assurance Team including the GLP Audit Program at the Ludwigshafen Site. Ensure adherence to GLP and GCP laboratory regulations. Develop an organizational model for internal GLP and GCP audit coverage and ensure appropriate capabilities and resources exists.
- Approval of Audit Reports, Action Plans and GLP QA statements
- Consultation of Test Facility Management, Study Directors and Principal Investigators regarding GLP and laboratory GCP requirements. Advocate for Quality Standards and clearly and logically justify such positions to be seen as a Subject Matter Expert and Advisor.
- Coordination and conduct of GLP trainings, functional area management review; prepare appropriate metrics and present significant events to senior management.
- Contribution to Quality System Documents (Policies, Processes, Procedures) in R&D as well as implementation in GLP QA
- Participation in the development of an organizational model for internal GSP assessments and ensure appropriate capabilities and resources exist.
- Primary contact for GLP regulatory bodies and GCP regulatory bodies for bioanalytical activities at the Ludwigshafen Site
- Coordination and monitoring of all regulatory actions in collaboration with Inspection Management
- Evaluation of new respectively revised regulatory or legal requirements and if applicable initiation of implementation in the R&D Quality System; and conduct of industry benchmarking.
- Attending Peer Industry working groups on relevant topics in GLP, GCP and Good Scientific Practices and other laboratory relevant regulatory guidance.
Qualifications
This is how you can make a difference:
- Master Degree in life sciences or engineering or other technical/scientific area
- Fluent in German and English
- Expert knowledge of national and global GLP Principles as well as basic knowledge of GCP and other relevant regulations and guidance
- 5+ years of experience in conduct of study and facility-based audits
- 2+ years’ experience in the conduct of audits at CROs and suppliers
- 2+ years’ experience on planning and conducting trainings and other relevant presentations
- 2+ years of people manager experience
- 2+ years of experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, quality assurance and/or regulatory affairs
- Relevant education in GLP and Audit techniques of quality assurance
- Fundamental understanding of toxicological and bioanalytical studies
- Key leadership competencies are relationship building, ability to influence at all levels, fostering teamwork, knowledge of the business, sound judgement, the ability to make difficult decisions, conflict resolution, strong oral and written communication skills and excellent interpersonal skills (English/German).
What we offer you:
- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible work models for a healthy work-life balance
- corporate health management with comprehensive health and exercise programs
- corporate social benefits
- diverse career options in an international organization
- high-level, attractive career development opportunities
- a strong international network
At AbbVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond! Sounds like the perfect career opportunity for you? We look forward to receiving your applicatio