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Director - Product Development Quality Assurance (all genders) (permanent / full-time)
Ludwigshafen am Rhein
Aktualität: 05.06.2024


05.06.2024, AbbVie Deutschland GmbH & Co. KG
Ludwigshafen am Rhein
Director - Product Development Quality Assurance (all genders) (permanent / full-time)
Make your mark: Establish, maintain, and execute quality systems to ensure disposition of clinical trial supplies, including API / drug substance, ingredients, bulk drug product and finished investigational products (pharmaceutical drug products as well as drug / device combination products), testing, and related documents Manages a quality organization of up to 5 direct reports and up to 50 total QA department members. 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
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. Experience in an R&D environment and with Investigational Medicinal Product preferred. 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. Considered a Subject-Matter Expert and key contributor to initiatives and advancement of the Quality organization Must be able to make critical, creative, and strategic decisions as a result of rapid analysis of available information. 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. Strong oral and written communication skills needed. 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