Associate Director
vor 7 Monaten
**The job that makes possibilities real in patients' lives. And yours.**
**The job that helps you get ahead in life. Moving mountains together.**
Welcome to AbbVie As part of an international company with 48,000 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
In our Pharmaceutical development department within Research and Development at the Ludwigshafen site, you will be working in a team of talented people and experienced experts toward developing tomorrow's products. In cutting-edge laboratories, you will be setting highest standards in the competitive field.
Moving mountains together - as **Associate Director (all genders) - GLP and Early Development Quality Assurance (permanent / fulltime)**
You are responsible for analytical method development and qualification, associated transfer activities into quality control areas, as well as support of QC related activities like clinical trial supply releases or stability programs to successfully drive pipeline and life cycle management of biologics projects including toxins.
**Your responsibilities**:
- 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
- For Good Scientific Practice act as Quality Process owner and consult R&D functional areas on establishing quality standards in these regards. Develop an organizational mode for internal GSP assessments and ensure appropriate capabilities and resources exists
- Main 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; conduct of industrial benchmarking
- Attending Peer Industry working groups on relevant topics in GLP, GCP and Good Scientific Practices and other laboratory relevant regulatory guidances
**Qualifications**:
Minimal educational requirements
- Master Degree in life sciences or engineering or other technical/scientific are
- Good command of English
Minimal requisite qualification
- Expert knowledge of national and global GLP Principles as well as basic knowledge of other relevant regulations and guidances (e.g. GCP, ISO17025, ISO15189, ISO13485)
- 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
- 5+ years of people manager experience
Other skills
- Several 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. Knowledge on test methods, standards and systems of the test facility
- 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
- Membership in professional organizations, e.g. GQMA, DGQ and IQ Consortium, for remaining current with peer organizations and providing opportunity to influence industry positions
**Here's how we can move mountains together**:
- 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
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