Sr. Quality Assurance Specialist (CSV)

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.

Job Description:

This position performs Quality oversight of Facilities and Engineering, Process Engineering, Process Automation, Validation and Quality Control.  The quality oversight responsibilities include the system qualification lifecycle, and product and process lifecycle activities, such as equipment, facilities, and utilities qualification, process automation qualification, process validation, cleaning validation, sterilization validation, computerized system validation, and shipping qualification. 

Key Responsibilities:

• Senior Quality Specialist will be tasked with the overall high vision and implementation of the QEV organization

• Will work with and establish relationship with Lonza Global partners to improve quality within the Vacaville site and within the Lonza network

• Collaborate with cross-functional teams, including validation, engineering, and manufacturing, to ensure quality throughout the product lifecycle

• Establish and implement Quality systems/programs and continuous improvement initiatives to improve product quality at the site 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.

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

• Initiate, own and drive the completion of CAPAs

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

• Apply advanced theory, technical principles, and expert judgement to address a broad range of difficult problems 

• Maintain a state of inspection readiness 

• Assess impact to the qualified state of equipment related to discrepancies for qualification relevant topics 

• Provide input to revised and new policies and procedures to effectively guide validation/qualification efforts 

• Solve a wide range of difficult validation/qualification, calibration and maintenance issues that impact multiple functions in alignment with cGMP regulations and Lonza standards 

• Assess the impact of changes to the qualified state of equipment during the operate and maintain phase.   

Key Requirements:

• Bachelor’s degree in life sciences, engineering, or relevant field.

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

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

• Experience in managing complex business setups and projects.

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

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.

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 and $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.

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