Technical QA Manager (m/f/d)

We are looking for a motivated and committed Technical QA Manager for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with the option to extend.

The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.

The candidate supports the end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products.

• Support of end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products
• QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and Biotech production
• Responsible to ensure QA oversight and setting guardrails for the operation facilities regarding GMP and Quality standards
• Support of implementation of DI requirements
• Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. Deviation records, CAPAs, SOPs, Risk Analysis etc.)
• Performing deep root cause analyses as a facilitator or expert to address and investigate complex problems independently
• Responsible for driving and optimization activities and improvements within IMP Quality Operations Switzerland
• Partner with stakeholders and provide guidance to ensure successful delivery of the IMP goals
• Represent and support your area of responsibility at HA inspections and internal audits

• Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
• Min. 5 years of Quality Management related experience in the Pharmaceutical industry
• Experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics
• Sound understanding on current DI (Data Integrity) requirements
• Experience with MES (Manufacturing Execution System)
• Profound knowledge of global quality and GMP requirements and a detailed understanding of current industrial trends in IMP
• Proven ability to work towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
• High expertise and experience in building and maintaining constructive and effective relationships with internal and external partners and stakeholders
• Strong team-player with a high level of self-motivation and being able to inspire others
• Ability to effectively influence others across all levels of the organization
• Strong collaboration across cultures, countries, technical competencies, and organizational levels
• Successful performance in health authority inspections and internal GMP audits
• Fluent German and English (spoken/written) is a must for this position
• Great communicator to stakeholders and in the team
• "Can-Do" attitude and self-confident to take over new responsibilities and tasks
• Ability to speak up, listening to other opinions and able to rethink the own way to ensure a highest level of success
• Knowledge of Pharmaceutical Development and about the special needs and road blocks regarding GMP-compliant production

Are you interested? Don't hesitate and send us your complete application documents online today.

We will also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!

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