Senior QA Specialist (Process Validation)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

This position performs Quality oversight of the Manufacturing Sciences (MSAT) Facilities and Engineering, Process Automation, Validation and Quality Control. This role primarily focuses on process validation. In addition, the quality oversight responsibilities include the system qualification lifecycle, and product and process lifecycle activities, such as process validation/verification, equipment, facilities, and utilities qualification, process automation qualification, cleaning validation, sterilization validation, computerized system validation, and shipping qualification.

The Senior QEV will be responsible for the overall strategic vision and implementation of the QEV organization. They will work with and establish relationships with global Lonza partners to enhance quality across the Vacaville site and the broader network. The role requires collaboration with cross-functional teams, including MSAT, engineering, and manufacturing, to ensure quality throughout the product lifecycle.

Key responsibilities:

• Implement quality systems and continuous improvement efforts to elevate product quality both onsite and at the global level.

• Ensure GMP requirements are met for qualification and validation of manufacturing equipment/systems, quality control equipment/systems, buildings, utilities, computerized systems and manufacturing processes, including the verification and alignment to license of each product.

• Actively participate, when required, in leadership roles such as QLT, VLT and Quality Council Meetings.

• Initiate, own and drive the completion of CAPAs.

• Review and approve all system lifecycle documents.

• Participate in local change management process as change assessor and/or change owner.

• Facilitate RCA to identify cause of deviations.

• Work with system owners, engineers, and Validation team to design, build, and test new systems to ensure the systems reliably meet their intended use.

• Partner with the MSAT, Validation and Qualification departments to ensure testing is performed effectively and efficiently.

• Ensure the execution of validation/qualification testing meets cGMP regulations and Lonza standards.

• Bachelor's in Life Science, Engineering or relevant field.

• 10+ years of quality oversight experience in the biopharmaceutical manufacturing industry is required.

• Experience with regulations (US, EU and other).

• Experience in leading complex business setups and projects.

• Experience working in multiple quality teams within the pharmaceutical industry.

• Tech Transfer experience desired.

We recognize that attracting, developing and retaining the best talent is key to our strategy and success as a company.  As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates.  As required by law in this state, the quoted salary range for this position is $115,000 - $195,000.  We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate’s experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza’s total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.