Technical QA Manager (m/f/d)

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Technical QA Manager (m/f/d)

Background:

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.

Tasks & Responsibilities:

• QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and/ or Quality Control
• 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. Qualification plans and reports, change and deviation management, 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
• 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

Must Haves:

• Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
• Profound experience in the pharmaceutical industry
• Experience in equipment Qualification/Validation of synthetic molecules manufacturing and/or Quality Control
• Sound understanding on current DI (Data Integrity) requirements
• Profound knowledge of global quality and GMP requirements
• Strong team-player with a high level of self-motivation and the ability to effectively influence others across all levels of the organization
• Successful performance in health authority inspections and internal GMP audits
• Fluent German and English (spoken/written) is a must for this position 

Nice to Have:

• 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

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining
• Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Marica Hug.

Basel-Stadt Pharma Chemie Quality Qualitätsmanagement QC Technisch QualitätsprüferIn