Basel Metropolitan Area
I am Stefan Bachmann, an accomplished Associate Director with a proven track record in External API QA Operations, specializing in global Contract Manufacturing Organizations (CMOs). Throughout my career, I have excelled in ensuring stringent regulatory compliance, driving quality assurance initiatives, and supporting groundbreaking product launches. My expertise spans quality agreement negotiations, regulatory inspections, and successful project validations under challenging timelines, reflecting robust problem-solving abilities and strategic leadership. I have a strong commitment to talent development, fostering team growth and enabling individuals to advance into leadership roles within QA. My background includes optimizing processes post-merger to enhance operational efficiencies and integrate diverse teams seamlessly. I thrive in dynamic environments where I can apply my deep understanding of GMP and GDP guidelines to drive continuous improvement and uphold quality management systems. Fluent in English and German, I bring a blend of technical expertise and strategic vision to drive quality excellence and operational success in pharmaceutical manufacturing.
Lead cross-functional team management and oversee quality assurance for multiple Contract Manufacturing Organizations (CMOs) globally. Ensure compliance with company standards and regulatory requirements, spearheading quality oversight for new product initiatives and technology transfers among CMOs. Drive quality agreement negotiations and reviews, approve critical regulatory submission sections, and offer QA support for product launches in new markets. Play a pivotal role in health authority inspections and conduct audits at vendor and supplier locations to uphold quality standards. ● Successfully validated and launched a new product, overcoming previous failures and meeting stringent timelines. ● Fostered professional growth within the team, enabling direct reports to advance into QA lead roles. ● Streamlined operations by integrating processes and procedures post-merger, resulting in more efficient workflows.
Managed a team responsible for quality assurance of internally manufactured Active Pharmaceutical Ingredients (APIs), ensuring adherence to stringent local and international quality policies and systems. Served as deputy FvP/Swiss QP, overseeing the release of APIs and intermediates from both internal manufacturing and Contract Manufacturing Organizations (CMOs). Fostered collaborative relationships with European Qualified Persons and acted as a singular point of contact for multiple CMOs on Quality and Compliance issues. Directed vendor quality management for commercial APIs and led quality assurance efforts for new projects and products at CMOs. Negotiated and reviewed Quality Agreements, contributed to the quality sections in regulatory submissions, and supported the launch of products in new markets. Participated in Health Authority Inspections and executed or supported audits at vendor and supplier locations. ● Streamlined communication with CMOs, enhancing efficiency in turnaround times for requests and deviations. ● Successfully validated and launched new products within challenging timelines, demonstrating strong project management and problem-solving skills. ● Developed direct reports, enabling them to assume QA lead roles, reflecting effective leadership and team development capabilities. ● Participated in Health Authority Inspections, showcasing a thorough understanding of regulatory requirements and compliance. ● Contributed to the quality sections in regulatory submissions, ensuring accuracy and compliance with GMP guidelines.
Oversight of several highly potent APIs from a QA perspective negotiation of Q-Agreements, participation in audits/inspections, dealing with CMOs, SMF-generation, participation in crossfunctional project teams, approving of QRA/CPP and Development report, executing SOP-Trainings, Process Validation, Handling of deviations, customer complaints, change requests and qualification of equipment. Defined and upheld local quality policies and systems, ensuring compliance with industry standards for API manufacturing. Acted as deputy FvP/Swiss QP, overseeing the release of APIs and intermediates produced both internally and by external vendors. Managed quality-related site activities, leading QA for new vendor projects and products. Negotiated and reviewed Quality Agreements, contributing to regulatory submission approvals. Provided QA support for product launches in new markets, participated in Health Authority Inspections, and conducted audits at vendor and supplier facilities. ● Improved the Quality Management System and SOP landscape, resulting in heightened compliance and fewer deviations or issues. ● Streamlined production processes by eliminating unnecessary equipment and piping, followed by successful requalification of new setups. ● Enhanced maintenance activities through efficient reorganization of production floor space, leading to more streamlined operations.
Oversaw the release of APIs and their intermediates, ensuring compliance with stringent regulatory standards. Acted as deputy FvP/Swiss QP for the API manufacturing site, managing all quality-related topics and providing essential QA support for product launches in new markets. Compiled and reviewed Quality Agreements, approved API sections in regulatory submissions, and participated actively in Health Authority Inspections. Supported audits at vendors and suppliers, reinforcing the supply chain's integrity and adherence to quality benchmarks. ● Successfully reduced lead time for the release of APIs, thereby maintaining continuous market supply and mitigating potential market shortages. ● Implemented an EHS emergency plan, enhancing preparedness for product spills and ensuring safety and environmental compliance.
Managed release processes for Active Pharmaceutical Ingredients (APIs) and intermediates, ensuring compliance with regulatory standards. Oversaw all quality-related issues, serving as the primary quality contact for multiple APIs. Directed change control, deviation management, and Corrective and Preventive Actions (CAPAs) to maintain product integrity and adherence to quality agreements. Reviewed and approved API sections for regulatory submissions, contributing to successful market launches. Actively participated in customer audits and Health Authority Inspections, demonstrating a strong command of Good Manufacturing Practices (GMP) and problem-solving abilities.
Managed cross-functional communication with international authorities, study centers, and subsidiaries to ensure seamless execution of clinical studies across all phases. Orchestrated supply chain operations for clinical trials, including the development of study-specific packaging designs and management of country-specific labeling requirements. Oversaw clinical study preparations with contracted service providers, ensuring adherence to protocols and regulatory compliance. Reviewed and verified study protocols and diagrams, enhancing accuracy and clarity for trial execution. • Successfully coordinated supply chain management for Phase I-IV clinical studies, optimizing resource allocation and timelines. • Developed and managed study-specific packaging designs, ensuring compliance with regulatory standards and study protocols. • Enhanced communication channels with international authorities and subsidiaries, fostering strong relationships and compliance with global regulations.