Technical QA Manager

Technical QA Manager (m/w/d)

• 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

• 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 (*****)

• 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

Application process