Senior QA Specialist (Change Controller/CAPA Manager)

Today, Lonza is a global leader in life sciences operating across five 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.

Lonza is at the forefront of life sciences, and we are excited to announce an outstanding opportunity for a Senior QA Specialist (Change Controller/CAPA Manager) in Vacaville, CA, this role is integral to our mission to deliver world-class quality solutions. As part of our Proactive Quality Systems team, you will collaborate with various departments, including Manufacturing, Quality Control (QC), Regulatory Affairs, and Engineering. This position has been built to support our ongoing growth and dedication to outstanding customer service.

Key responsibilities: 

• Highly self-motivated, well organized and able to develop alternative solutions to issues. 

• Ability to communicate clearly and professionally both in writing and verbally 

• Proven track record for being reliable and taking ownership and solving problems 

• Sound decision making skills 

• Ability to interpret Quality standards for implementation 

• Lead and facilitate the end-to-end change control/CAPA process, from initiation and impact assessment to implementation and closure. 

• Coordinate Change Control Board (CCB/TCCRB) meetings, ensuring all proposed changes are thoroughly reviewed for potential impact and risk. 

• A proactive, can-do attitude with a strong sense of accountability and attention to detail.   

• Proven track record of demonstrating strong teamwork and collaboration.  

• Demonstrated ability to manage multiple projects simultaneously and work effectively in cross-functional teams.  

• Maintain an up-to-date understanding of cGMP regulations (e.g., 21 CFR Parts 210/211), FDA regulations, and ICH guidelines pertaining to Quality Systems 

Key requirements:

• B.S. degree in Life Sciences or relevant field.

• A minimum of 5+ years of experience in a quality role within the pharmaceutical, biopharmaceutical, or a similar regulated industry.

• Excellent communication skills; strong organizational and problem-solving skills, with the ability to work independently, manage multiple projects simultaneously, and take ownership of tasks.

• Proficiency in Microsoft Office Suite (Word, Excel), Adobe Acrobat, electronic Quality Management Systems (eQMS) such as Veeva.

• Ability to interpret and apply Quality standards for implementation.

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 $105,000 - $167,000.  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.

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.