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    (Senior) Quality Assurance Manager (M/F/D) And Deputy Rp 80%

    Teva Pharmaceuticals
    7+ years
    Not Disclosed
    Basel
    10 Nov. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: (Senior) Quality Assurance Manager (m/f/d) and Deputy RP 80%

    Location: Basel, Switzerland, 4010
    Company: Teva Pharmaceuticals
    Job ID: 58305
    Date: Nov 9, 2024

    About Mepha and Teva in Switzerland

    Mepha Pharma AG and Teva Pharma AG are leaders in the Swiss pharmaceutical market. Since 2011, Mepha has been part of the Teva Group, one of the world’s largest generic medicine suppliers. Together, they employ 174 people and offer a broad portfolio of over 320 products, including generics, biosimilars, medical products, and original medicines. In 2023, Mepha and Teva were the top-selling pharmaceutical companies in Switzerland, with 23 million packs sold.

    The Opportunity

    Teva Switzerland is seeking a Senior Quality Assurance Manager to join the Commercial Quality Team. This role will be responsible for ensuring compliance with GMP and GDP regulations, managing product releases, overseeing quality incidents, and supporting product launches. The individual will also act as the Deputy Responsible Person (RP), handling quality assurance duties and representing the Quality Unit Team in cross-functional projects.

    Main Responsibilities

    • Market Release & Quality Control:

      • Oversee Swiss market product releases in the absence of the RP, managing deviations and change control processes.
      • Act as Deputy RP (Stv. FvP), ensuring compliance with regulatory standards.

    • Quality Incident Management:

      • Lead the management of quality incidents, including complaints, recalls, and product-related issues.

    • New Product Launches:

      • Manage major product launches to ensure adherence to quality standards.

    • Document & Process Management:

      • Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions.
      • Contribute to continuous improvement initiatives and staff training.

    • Inspection & Audits:

      • Support inspection readiness, assisting with local authority inspections and conducting internal audits.

    • Cross-Functional Collaboration:

      • Represent Swiss Quality Assurance within Teva’s European Commercial Quality organization.
      • Collaborate with departments like Regulatory Affairs, Pharmacovigilance, Supply Chain, and Customer Services.

    Experience & Qualifications

    • Educational Background:

      • Master’s degree in Pharmacy, Medicines, Biology, or an equivalent field.

    • Work Experience:

      • Minimum 7 years of experience in the pharmaceutical industry, with at least 5 years in a QA/QC role, preferably including Swiss market release.

    • Skills & Knowledge:

      • In-depth knowledge of GMP/GDP guidelines and Swiss and European pharmaceutical regulations.
      • Matrix leadership experience and proficiency with MS Office software.
      • Strong communication and interpersonal skills, with fluent German and English.

    • Personal Attributes:

      • A detail-oriented, proactive, and quality-conscious individual with the ability to work systematically.
      • Team-oriented with a willingness to embrace change.

    What We Offer

    • Dynamic and Varied Role: Opportunity to engage in a diverse and exciting position within a growing organization.
    • Professional Development: Gain valuable insights into various business processes within the pharmaceutical industry.
    • Progressive Benefits: Enjoy perks such as a lunch card, public transport allowance, and work at Teva’s central office, just minutes from Basel SBB train station.

    Teva’s Equal Employment Opportunity Commitment

    Teva is committed to creating a diverse and inclusive workplace. We provide equal employment opportunities regardless of age, race, gender, disability, and other legally protected statuses. If you need accommodations during the recruitment process, please inform us, and we will ensure a supportive, accessible candidate experience.

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