Global Quality Manager (m/f/d)

As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Basel and Kaiseraugst, we are currently looking for a motivated and dedicated Global Quality Manager for a temporary assignment of 6 month.

Tasks & Responsibilities

• Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making
• Global Oversight: Maintain Global QA oversight for the entire Roche IMP Distribution Network and its business counterparter PTDS-L.
• Lead the Deviation Management process by performing product quality impact assessments. Provide crucial Quality oversight by reviewing and assessing final evaluations and statements from third parties, ensuring consistency with regulatory standards, and checking if proposed Corrective and Preventive Actions (CAPA) are appropriate.
• System Owner: Manage the full lifecycle of quality documentation and Change Records, including establishing, reviewing, and approving critical documents and changes for both internal procedures and external business documents (PTDS-L).
• Inspection Management: Actively drive and support all GxP inspections and audits.
• Quality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and managing Expert Statements/Opinions.
• Support clinical studies by reviewing and approving IMP Supply & Release Flowcharts, Transfer requests, and Expert Opinions.
• Establish and approve Master Quality Agreements and Quality Agreements.
• Manage Complaint Management for clinical trials within the Roche network.
• Support quality-related and business-driven projects within the IMP Distribution network.
• Drive continuous improvement activities
• Professional Discipline: Assure GMP/GDP compliance, adhere to Good Documentation Practices (GDP), and ensure training
  compliance with PQS documents 

Must Haves

• A Bachelor's degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering)
• Proven and comprehensive experience (min. 3 years) in Quality Assurance with a strong focus on compliance
• Deep knowledge of a regulated GxP environment (GMP/GDP)
• Fluent speaker and writer in English (German is a plus). Fluency is essential for managing critical regulatory documentation, providing authoritative guidance to European sites, and ensuring successful support during Health Authority Inspections

Nice to haves

• Familiarity with Veeva vault QMS
• Roche experience
• PTQ experience
• Experience in supplier management especially depots

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card

Are you interested? Do not hesitate and submit your complete application documents online today. We look forward to hearing from you!
 

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Kontakt
Adnan Ferizi

Arbeitsort
Basel

Pensum
100%

Position
Mitarbeiter

Branche
Elektro + Mechanik