Europe Investigational Medicinal Products Qualified Person Principal Manager (w/m/d) Vienna, Vienna Category: Quality

Job description

Europe Investigational Medicinal Products Qualified Person Principal Manager (w/m/d) Vienna, Vienna Apply Now Job ID R0193952 Category Quality Subcategory Quality Business Unit Global Quality Job Type Full time By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role Join Takeda as Europe IMP Qualified Person Principal Manager. In this role, you will help ensure the quality and compliance of Takeda’s investigational medicinal products throughout clinical development and through commercialization. As part of Research and Development Quality, you will provide quality oversight across a complex portfolio that may include biologics, synthetic molecules, plasma-derived therapies, cross-modality conjugates, combination products and other emerging modalities. You will work with internal teams, contract manufacturing organizations and partner companies to support high-quality pharmaceutical development and operations. Your work will contribute to compliant products, effective collaboration and sound quality decisions across global programs. You will independently manage projects and programs, using your expertise to support business priorities and provide guidance except in the most business-critical situations. How You Will Contribute Reporting to the Head of R&D GMP Pharmaceutical Sciences Quality EU&US, you will : • Perform QP certification activities as set out in Article 51 of directive 2001/83 and Article 61 and 62 of CTR 536/2014 for Takeda IMPs in accordance with their Clinical Trial Authorization (CTA), their IMP Dossier and their Manufacturing Authorizations, the Product Specification File and the principles and guidelines of cGMP as laid down in Directive 2017/1572 and Delegated Regulation 2017/1569 and in accordance with principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products. • Oversee and conduct final release and disposition of Clinical Trial Material (CTM) including different modalities and more complex internal and partnership programs. • Depending on complexity of programs, different modalities out of Biologics, Synthetic Molecules, Plasma Derived Therapies, Cross Modality Conjugates and other new Modalities including Combination Products, requiring the interaction with several Contract Manufacturing Organisations (CMOs) or partnership companies • Batch documentation review and release activities per Takeda quality systems • Review and approve Master and Executed Batch Records and Packaging Labels. • Review and approve analytical test methods protocols, reports, specification documents, method qualifications/validations, and stability studies plan/reports as they pertain to Clinical Trial Materials. • Accountable that quality issues (deviations/events, OOX (OOT, OOL, ..), and complaints are adequately investigated and documented and provides support for the development of an appropriate corrective/preventive action plan and execution to prevent recurrence of quality issues. Collaborates with stakeholders (Pharm Science, Global Clinical Supply Chain, etc.) to execute the investigation of quality event by providing proactive support. May lead more complex regional QA investigations. • Engage cross-functionally on behalf of R&D GMP Pharmaceutical Sciences Quality to serve key business partners. Builds a good relationship with Pharm Science Team members to enhance agility for pharmaceutical development and to achieve high-quality products. • Responsible to identify applicable regulations and standards to ensures compliance with applicable regulations, cGMP and Takeda Quality standards for GMP pharmaceutical operations related to manufacturing, testing, packaging, and distribution of investigational drug product and investigational active pharmaceutical ingredients (API). Identifies compliance gaps and proposes solutions. • Provide strategic GMP quality/compliance guidance to internal stakeholders by serving as GMP QA authority on Pharm Science Team. • Provide strategic GMP guidance to third-party vendors to ensure product meets Takeda's quality expectations and compliance of Takeda products with cGMP • Supports and/or leads continual improvement initiatives in order to enhance R&D GMP Pharmaceutical Sciences Quality operating efficiencies and innovation in support of all processes involving R&D GMP Pharmaceutical Sciences Quality as responsible function. Engage cross-functionally on behalf of R&D GMP Pharmaceutical Sciences Quality to serve as key business partners. • Partner with CMC (chemistry, manufacturing and controls) submission teams to provide technical quality support for chapters of regulatory filings of assigned programs that are in responsibility of R&D GMP Pharmaceutical Sciences Quality. • Supports external auditing program. Involvment in external audits as QP to assure compliance with GMPs, regulatory filings, FDA, EU and other applicable regulatory guidelines. Leads Preapproval inspection preparation for programs/products that are assigned and supports as SME others in their activities. • Supports GMP Supplier Quality Management activities, including qualification and Quality technical Agreements including and beyond programs/products that are assigned. Qualifications • Eligibility to act as a Qualified Person under applicable local and European Union requirements. • A bachelor’s degree in pharmacy, chemistry, biology, engineering or a related field. An advanced degree is preferred. • At least five years of progressively responsible experience in pharmaceutical manufacturing, packaging, laboratory operations, quality assurance, quality control or compliance. • At least three years of experience working as a Qualified Person. Experience as an investigational medicinal product Qualified Person is preferred. • Quality auditor certification is preferred. • Comprehensive knowledge of current international regulatory requirements and guidance for the pharmaceutical industry and their application to pharmaceutical development. • Proven ability to critically review completed manufacturing documentation and assess compliance with regulations, procedures, regulatory filings and clinical trial authorizations. • Demonstrated teamwork, initiative, problem-solving and decision-making skills. • Ability to anticipate issues and proactively implement solutions. • Strong organizational, communication and relationship-building skills, including the ability to work effectively with internal and external stakeholders and senior management. • Experience working in complex, global and matrixed environments. • Ability to influence stakeholders and negotiate practical, mutually beneficial solutions. • Strong interpersonal and professional skills, with the ability to represent Takeda when working with external contract manufacturers, suppliers and testing laboratories. • Ability to work in or visit pharmaceutical production and processing facilities, including active pharmaceutical ingredient manufacturing, pharmaceutical product manufacturing, packaging, component printing and analytical laboratories. • Fluency in English and willingness to travel approximately 10%, including domestic and international travel with overnight stays.Haut du formulaire What we offer you: A competitive remuneration package with total Base Pay Range between 83’800.00 - 125’800.00 EUR Annual. Locations AUT - Wien - Industriestrasse 67 Worker Type Employee Worker Sub-Type Regular Time Type Full time Apply Now Share this job • Facebook • Xing • LinkedIn • Email • Related content • Learn more • Frequently Asked Questions Learn more • Healthcare for all Learn more