Group Quality API Manager (m/f/d)

Group Quality API Manager (m/f/d)

• Location: Basel
• Start Date: as soon as possible

Responsibilities

• Collaborate with local quality departments to ensure GMP readiness of new and legacy API facilities, including pre-licensing preparation, efficient startup, and product lifecycle management.
• Collaborate with cross-functional teams to ensure quality operations compliance with local and global quality regulations during the development, manufacturing, and release of APIs.
• Conduct KPI surveillance and internal audits to elevate particular areas of risk or concern for API production and enforce remediation actions to support inspection readiness and increase API process robustness.
• Act as a Subject Matter Expert for GxP compliance of API quality operations & analysis and drive for further digitalization.
• Support the local quality organization in executing the Quality Culture Program and adopting Quality behaviors.
• Master the complexity of the API manufacturing processes within the group and understand the potential sources of variability using digital GxP systems.
• Collaborate in Quality ad-hoc boards in case of API related escalations to management, immediately after being notified by a site, to ensure and support timely actions, effective communication, thorough investigation, and effective CAPAs.
• Provide expertise in the implementation and optimization of global quality systems across API manufacturing sites.
• Provide training and expertise to global teams on quality requirements, GMP practices, and industry regulations.
• Lead and support the global harmonization of local quality management systems, ensuring they meet regulatory and internal requirements for API manufacturing.
• Promote the principles of process design and the development of a comprehensive control strategy for manufacturing APIs of consistent quality by ensuring a practical application of quality-by-design (QbD), identification and mitigation of risks, and process characterization.
• In collaboration with the Operational Excellence department, foster a culture of quality excellence by driving continuous improvement initiatives and best practice sharing across the global network.

Your Profile

• University degree in Chemistry, Pharmacy, Biology, Engineering or other technical/natural scientific area.
• Minimum of 5-8 years of work experience in manufacturing, quality control, quality assurance or other relevant area, in an API producing pharmaceutical/CDMO company.
• Profound knowledge of EU GMP and FDA regulations.
• Experience with electronic Lab, Quality, and Documentation Management Systems.
• Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment.
• High carefulness and accuracy in the way of working, conscientiousness and detail-orientation, strong ability to systematically gather and analyze data.
• Strong interpersonal and communication skills, capable of influencing and collaborating with cross-functional teams globally.
• Fluent in English; French, Italian, or German are an asset.
• Available for international travel up to 20%.

Working Environment

Positive working atmosphere and open management culture with a focus on continuous improvement of processes to stay innovative.