Director (English/German Speaking)

vor 4 Wochen

Ludwigshafen am Rhein Ludwigshafen am Rhein, Deutschland AbbVie Deutschland GmbH & Co. KG Vollzeit

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. Global impact. At AbbVie 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 the tomorrow's unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? In a challenging work environment that offers opportunities of developing and increasing your own skills? Moving mountains together – as Director – Product Development Quality Assurance (all genders) (permanent / full-time) REF: R00106564 Make your mark: In our Product Development QA 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. Directly responsible for the effective organization, administration, training, and supervision of the Product Development Quality Organization Drive drug development project implementation via roles on the CMC Team or other cross-functional product subteams as needed to proactively avoid, manage, or address quality-related issues Collaborate cross-functionally (e.g., with Dev Sci, DevOps, Regulatory Affairs, Medical Safety, and Operations) to ensure early involvement of global key decision makers and prepare for aligned decision-making Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required Ensure quality and safety of IMP. Ensure compliance of IMP: pharmaceutical drug and drug/device combination products with worldwide quality and regulatory requirements and IMPD / CTA applications Establish and regularly evaluate quality and key performance indicators, forwarding data for management reviews and communication to business partners Provide management oversight of review and approval of manufacturing and analytical batch records, exception reports, OOS reports, and changes in the quality system, Responsible for Quality Management in pilot plants and labs Ensure that EU GMP requirements are appropriately addressed in collaboration processes (e.g. global product supply chain, QP role, execution of the Quality System) and in the respective Technical Quality Agreements (TQAs) Ensure suitable quality agreements or quality aspects of contracts for GMP-controlled activities are in place between R&D and third-party manufacturers, third-party labs, other service providers, customers, and other sites Support integration of acquisitions and perform GMP assessment of due diligences or in-licensing activities Develop a risk-based approach for decision-making and support continuous improvement via development of cost-efficient processes at sites, and collaboration between sites to optimize global processes and share best practices Advance local and global initiatives on continuous improvement and strategic initiatives in areas of responsibility Qualifications: Bachelor’s Degree, or equivalent work experience, required in Pharmacy, Chemistry, Biology, or Microbiology. Master’s Degree or PhD preferable Expertise as a Qualified Person (QP) pursuant to Article 15(1) of the German Drug Law (Arzneimittelgesetz, AMG) and multi-year practical experience as QP preferable At least 10 years of experience in the pharmaceutical industry, should include roles in Quality Assurance and experience in manufacturing, finishing, or testing of medicinal products. 5+ years of management experience, preferably direct management Thorough understanding of the pharmaceutical product development cycle and expert knowledge of worldwide regulatory requirements and GMPs. This must include thorough risk-assessment for the patient and for the business Skilled in the initiation, selection, coordination, and management of projects and have ability to resolve complex technical problems by providing innovative solutions. Must be able to formulate decisions and approaches in the complex environment of global investigational material supply chains with all the business partners and interested parties involved (R&D, Operations, TPMs and TPLs, affiliates, service providers, etc.) Must have strong leadership skills, take positions on Quality issues and standards, and be capable of clearly and logically justifying such positions, both internally and externally Conflict resolution skills including persuasive management techniques required. Excellent interpersonal skills required to interact with and have ability to influence decisions of senior management in all areas Excellent knowledge of both written and spoken English 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 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. Sounds like the perfect career opportunity for you? 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. For more information about AbbVie, please visit us at (Inhalt entfernt).

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