Process Technical Lead - Infrastructure Quality

About the role

This role is based in the Global Quality & Regulatory Network, which together with our partners in R&D, operations and supply chain, ensures that our products are available to healthcare systems in the highest quality and in sufficient quantities. This is our contribution to the prevention and diagnosis of diseases for the benefit of many hundreds of millions of patients worldwide.

Responsibilities

• Standardize and enhance Infrastructure Quality practices across Global Quality and Regulatory teams and DIA Partners.
• Manage equipment & infrastructure Q&V, change control, nonconformance management, quality support for Global Customer Support, audit support, and process monitoring.
• Ensure consistent partnership quality and predictable interactions.
• Align quality practices with business goals by defining enablers, participating in solution definitions, and managing capacity.
• Collaborate strategically with Operation Quality Chapters and Networks to drive capability development, ensure knowledge sharing, and foster sustainable work practices.
• Develop a strategic vision and tactical plan to manage cross-network collaboration efficiently.
• Partnership with Network Leadership and the Quality System Excellence Chapter to improve productivity, reduce costs, and standardize processes.

Qualifications

• Bachelor’s / Master’s degree in Life Science, Pharmacy or related subject.
• Advanced degree is considered an advantage.
• Demonstrated experience and knowledge of Quality Operations and processes.
• At least seven (7) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience.
• Demonstrated experience in European, US, and other relevant Health Authority inspections.
• Excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards.

Skills & Abilities

• Strategic Thinking: Identify improvement opportunities and create actionable plans. Analytical skills help drive continuous improvement.
• Matrix Leadership: Influence, coach, and develop talent in a matrixed organization.
• Process Modelling/Engineering: Define, implement, and improve business processes.

Locations

• Primary role: Onsite in Branchburg, Mannheim, Penzberg, Rotkreuz, Indianapolis or Tucson.

Pay

The expected salary range for this position based on the primary location of Branchburg is $135,500 and $251,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Benefits

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Branchburg. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.