- Management of the GLP Audit Program at the Ludwigshafen, Germany site. Ensure adherence to GLP and GCP laboratory regulations.
- Review and approval of Audit Reports, Action Plans and GLP QA Statements.
- Consult with Test Facility Management, Study Directors and Principal Investigators regarding GLP and laboratory GCP requirements.
- Coordination and/or conduct of GLP trainings, prepare appropriate metrics and present significant events to the senior management staff.
- Contribution to Quality System Documents (Policies, Processes, and Procedures) in R&D.
- Point of Contact for GLP and GCP regulatory bodies regarding bioanalytical activities at the Ludwigshafen Site; Including coordination and monitoring of all regulatory actions in collaboration with Inspection Management.
- Evaluation of new and/or revised regulatory requirements; and if applicable initiation of implementation in the R&D Quality System.
- Master Degree in life sciences or engineering or other technical/scientific area
- Expert knowledge of national and global GLP Principles as well as basic knowledge of GCP and other relevant regulations and guidance.
- 2+ 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
- Fluent in German and English
- 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
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Senior Manager Preclinical QA - Ludwigshafen, Deutschland - AbbVie
Beschreibung
Job DescriptionAs part of our Research and Development team, you will be contributing to finding solutions and helping pave the way for innovative therapies that address complex diseases using innovative research approaches and state-of-the-art technology.
Further develop your expertise and join our team as Senior Manager Preclinical QA (all genders) (permanent / fulltime).
With a lot of experience and even more passion, you will be joining our team in the Research and Development Quality Assurance (RDQA) – Preclinical QA Unit . This role will be principally for ensuring adherence to GLP as well as GCP laboratory regulations and for assisting in developing an organizational model for the Preclinical Quality Assurance Unit. Additionally, this role will manage a team of audit professionals with principal responsibility for quality oversight of GLP and GCP regulated study activities.
This means:
This is how you can make a difference:
What we offer you:
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 application. All you need is a complete CV – anything else will be discussed in person, where possible, if general suitability is determined.
At AbbVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond
Have questions? Email us at – we look forward to hearing from you
Additional InformationAbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
