Associate Director, CQ Regional Lead

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 dedicated 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!

The Regional CQV Delivery Lead supports CQV activities and CQV teams across the network in the US to ensure that project teams apply world class standards and practices in the area of commissioning, qualification and validation (CQV).

Key responsibilities:

• Coordinate the implementation of Global CQV strategies for projects within the assigned portfolio.

• As part of project initiation, collaborate with Global Engineering and Sites to develop C&Q Plan in alignment with Global and site standards.

• Act as a signatory and provide oversight to CQV signatory delegates to ensure documentation is complete and accurate in compliance with regulatory requirements. This includes compliance of templates developed within Kneat.

• Manage staffing for projects, identify and lead internal or external resources for appropriate project execution.

• Manage and report on CQ progress based on Global performance goals. Report on metrics, including any potential delays and risk mitigations to project leadership as a member of the project Core Team.

• Collaborate with Site Operations/site Validation teams for successful handover of systems for PQ activities.

• Responsible for successful delivery of CQ in support of system acceptance and area release of projects within the assigned portfolio

• For projects involving Kneat, serve as an SME to ensure templates and validation protocols are accurate and in alignment with Global procedures

Key requirements:

• BS degree or higher (preferably in Engineering) with 10+ years of relevant experience.

• Deep understanding of Pharmaceutical/Bio Science Contract Manufacturing and cGMP standards.

• Strong leadership skills with the ability to work across global teams and contexts, up to 20% travel is expected.

• Skilled in linking financial/commercial insights to project goals, costs, schedules, and risk.

• Experienced in resource/time/cost estimation and has served as CQV Lead and/or Project Manager.

• Able to manage ambiguity, adapt to fast-paced environments, and implement global processes/tools while training/supporting others.

• Proven experience with customer and regulatory audits, ensuring CQV documentation is audit-ready at system handover.

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 $158,000-$268,000.  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.