Senior Quality Program Specialist

Lonza is a leading global company with more than 30 sites across five continents, dedicated to manufacturing the medicines of tomorrow. The company embodies core values such as Collaboration, Accountability, Excellence, Passion, and Integrity, reflecting its culture and approach to teamwork and innovation. Lonza fosters an inclusive environment where diverse perspectives are valued, believing that everyone’s ideas, whether big or small, can impact millions of lives. As a globally connected team, Lonza continuously pushes the boundaries of science and technology to develop breakthrough therapies and support the evolving needs of the biopharmaceutical industry. Lonza also commits to equal employment opportunities, ensuring a workplace free from discrimination based on race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other protected characteristic. This dedication to diversity enhances the company’s ability to innovate and deliver exceptional products and services worldwide.

The Senior Quality Program Specialist position at Lonza is based in their Walkersville, MD office, offering a standard Monday through Friday, 8:00 AM–5:00 PM EST work schedule. This is a full-time role with an annual salary expected to range between $95,000 to $153,000, complemented by an extensive benefits package including medical, dental and vision insurance, 401(k) matching, life insurance, short-term and long-term disability coverage, paid time off, employee assistance programs, and performance-related bonuses.

In this critical role, the Senior Quality Program Specialist ensures that Lonza’s operations comply with ISO and cGMP quality system requirements as well as applicable regulatory standards. Acting as a Quality Assurance Subject Matter Expert (SME) for equipment qualification, cleaning validation, computer system validation, and facilities-related quality systems, the specialist provides independent quality oversight and supports both operations and quality control teams. The role is pivotal in audits, inspections, continuous improvement initiatives, and overall quality system governance, demonstrating leadership qualities by potentially directing and mentoring other team members.

Key responsibilities include verifying compliance with quality system requirements, reviewing and approving qualification and validation protocols and reports, providing quality oversight for cleaning validation and equipment maintenance, and responding in real-time to compliance issues. The specialist also oversees and approves corrective and preventive actions (CAPAs), deviations, investigations, out-of-specification reports (OOTs), and change control documentation. Using systems such as Document Management Systems (DMS), Laboratory Information Management Systems (LIMS), and TrackWise, the specialist performs critical quality system activities. They also serve as the interface during audits and regulatory inspections, representing the Quality Assurance department both internally and externally.

Lonza seeks a candidate with a minimum of seven years of relevant experience in quality assurance, validation, quality systems, or regulated biopharmaceutical manufacturing environments, supported by a bachelor’s degree in a scientific, engineering, or related technical discipline. The ideal applicant will have strong technical writing skills, extensive knowledge of cGMPs, ISO standards, FDA regulations, and quality unit requirements, and demonstrated expertise in computer system validation and equipment qualification. Proficiency in MS Office tools and quality systems such as TrackWise is essential, alongside the ability to manage multiple priorities, lead quality improvement projects, and foster a strong quality culture through coaching and mentoring. Experience interacting with FDA or other regulatory agencies is highly preferred.

This role offers a unique opportunity to be part of a global leader in life sciences, contributing directly to the quality and compliance of products that make a difference in healthcare. Lonza prides itself on innovation driven by diverse talent, and joining the team means actively shaping the future of life sciences while advancing your professional career in an environment that values continuous growth and development.