Overview
Join to apply for the Head QA, manufacturing equipment qualification CQV 80-100% role at Lonza.
Location: Stein, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
Lonza is a global leader in life sciences. As Head QA, manufacturing equipment qualification CQV, you will be part of the Site Quality Leadership team, shaping the quality landscape at Lonza AG in Stein, and contribute to integrating a Greenfield project (building several new production lines) into the existing manufacturing environment.
What You’ll Get
* An agile career and dynamic working culture
* An inclusive and ethical workplace
* Compensation programs that recognize high performance
* A wide range of lifestyle, family and leisure benefits; full list of local benefits is available
Key responsibilities
* Establish and maintain the Equipment Qualification System at Lonza Drug Product Services (DPS), including commissioning, process and computerized systems validation, and qualification of manufacturing equipment.
* Lead and develop a team of QA Experts, guiding them in line with Lonza’s values and behaviors, including objective setting, performance evaluations, development planning, and participation in recruiting. Promote high performance and trust; identify proficiency gaps.
* Ensure accurate qualification of equipment, infrastructure, and computerized systems by adhering to corresponding VMPs. Support and implement global CQV procedures. Serve as the first contact for documents related to equipment, infrastructure, and computerized systems qualification & maintenance within QA.
* Supervise compliance activities such as GMP status, trend analysis of equipment, qualification/re-qualification related to supplier qualification, changes, nonconformities, CAPAs, audit/inspection observations, and document management.
* Collaborate with other sites and global teams to improve and align CQV processes within Lonza. Ensure decisions are supported by global and local Quality and Regulatory standards.
* Ensure effective use of resources (budget, time, personnel, systems).
* Coordinate qualification of equipment suppliers/services by supervising adherence to quality agreements and audit observations. Track GMP status of service providers, including calibration, maintenance, and consultants.
Key requirements
* Degree or equivalent experience in Life Science, Engineering, or a related field
* Several years of leadership experience
* Work experience in Quality Assurance
* Solid experience in qualification topics within pharmaceutical, GMP-controlled sterile manufacturing, including CQV
* Experience with audits, including front office involvement; experience with Swissmedic is an advantage
* Demonstrated ability to uphold quality standards and make decisive calls in fast-paced environments with competing priorities
* Proficiency in English; German language skills are a plus
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, or any other characteristic protected by law.
Reference: R69390
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