Teamlead Global Quality

Vor 3 Tagen


Stuttgart, Baden-Württemberg, Deutschland Wörwag Pharma GmbH & Co. KG Vollzeit

Job Description:

  • Full disciplinary and functional Leadership of the Release Compliance Team (with ≈ 9 employees) including Performance Management and Talent Development

  • Execution of batch certifications as Principal Qualified Person on behalf of Wörwag Pharma and AAA Pharma

  • Deputy for the Head of Global Quality Operations/QP and for the Team Lead Product Compliance/QP; supporting them in all strategic and operational activities

  • Ensure the timely and correct execution of the team's core responsibilities, including:

— Batch releases of API, bulk and finished products

— Compilation of periodic product quality reviews (PQRs)

— Management of ongoing stability studies at CMOs and external laboratories

Management and provision of documents e.g. change information, dossier transfers and other data to all CMOs to ensure compliant production

  • Case Management for critical, major or business-impacting events derived from compliance gaps, deviations, OOS/OOE and complaints

  • Overseeing budgeting, ordering and invoicing in area of responsibility

  • Representing Global Quality Operations in selected Projects as well as contributing to or leading Key Activities

  • Development and independent implementation of measures to continuously improve the Group & Headquarter Quality Processes, including the:

— Supervision of Process Owners in the area of responsibility

— Authorship or review of global & local SOPs and working instructions

— Representation of such topics in health authority inspections and internal audits

— Recording, evaluation, reporting, trend analysis and performance improvement of relevant KPIs

*****

Job Requirements:

  • Qualification as EU Qualified Person (Sachkundige Person) according to §15 AMG, e.g.:

— As licensed Pharmacist or equivalently recognized degree

— Or alumnus of a QP Postgraduate training program (e.g. from Academy for the Pharmaceutical & Chemical Industry)

— with appropriate practical experience in Quality Control and/or Analytical Development of Medicinal Products

  • Professional experience of at least 5 years in the pharmaceutical industry, ideally in the areas of quality control/analytics, quality assurance and/or as a QP

  • Sound knowledge of pharmaceutical guidelines and norms (e.g. EU GMP guidelines, ICH guidelines, AMG, AMWHV, Pharm.Eur.) and their respective interpretation and application

  • Experience as line manager and/or coordinating matrix/project teams is of advantage

  • Experience in dealing with outsourcing partners (contract manufacturing organizations and/or contract laboratories) is of advantage

  • Proficient to work in an interdisciplinary and international environment and under pressure to meet the requirements of our customers and partners

  • Proactive and innovative mindset with the capability to find pragmatic solutions and to advocate accordingly

  • Confident communication skills on all hierarchical levels and in global collaboration, fluent in English and preferably also in German

*****

Benefits:

  • Up to 60% Remote Work possible

  • flex working hours

  • Competitive Base Salary

  • Bonus Payment

  • subsidized pension scheme

  • 30 vacation days + 3 additional days or financial equivalent

  • job ticket subsidy

  • subsidized canteen

  • free parking

  • free coffee

  • modern office

  • fun and social company events throughout the year

  • health days with nutritional, physical and mental fitness offers

  • access to Corporate Benefits Portal and Voucher Programs



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