Senior QA Qualification Specialist Manager

Compile, review and release Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports, etc.) Perform assessments and approvals of technical change requests and their relevance to the qualified state of equipment, utilities and systems Support and approve quality risk analysis (e.g. FMEA) Ensure relevant deviations are appropriately investigated and recorded in Deviation Reports Responsible to drive CAPA and Effectiveness Checks items to completion and timely closing Confirm the qualified state of facilities, equipment and systems during their life cycles by ensuring periodic reviews or periodic re-qualifications Ensure that documents are correct and adhere to SOPs and customer’s requirement Represent specific areas as Subject Matter Expert (SME) and provide guidance’s and recommendations in these areas to internal customers Lead or support specific projects in his area of SME to develop further the quality standards Write or revise SOPs in his area of SME and acts as Owner of such documents Enhance the quality knowledge by following the quality standards and by visiting specific training courses/congresses Identify areas of non-compliance through internal audits or other observations Represent qualification topics during customer audits and regulatory inspections Support cGMP training programs to ensure staff is being trained Train and mentor junior employees to better accomplish and perform in their duties as quality professionals

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Academic degree in Engineering/ Chemistry/ Biotechnology or related field

• Significant experience in the pharmaceutical Drug Product industry, ideally in a QA role

• Good understanding of the applicable cGMP regulations

• General knowledge of engineering and manufacturing processes

• Subject matter expertise in cGMP compliant qualification

• Able to work autonomously with established procedures

• Excellent verbal, written and interpersonal communications skills in German AND English required

• Ability to pay attention to accuracy and detail

• Ability to work in partnership as an active member of a team and/or cross functional working groups

• Strong individual contributor and decision maker