Senior Quality Program Specialist

Sr. Quality Program Specialist

Location: This position is based in our Walkersville, MD office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

What you will get:

The full-time base annual salary for this position is expected to range between $95,000 to $153,000. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.

• Medical, dental and vision insurance.

• 401(k) matching plan.

• Life insurance, as well as short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

The Senior Quality Program Specialist is responsible for ensuring company compliance with ISO and cGMP quality system requirements and applicable regulatory guidance. This role serves as a Quality Assurance Subject Matter Expert (SME) for equipment qualification, cleaning validation, computer system validation, and facilities-related quality systems.

The ideal candidate provides independent quality oversight, supports operations and quality control teams, and plays a key role in audits, inspections, continuous improvement initiatives, and quality system governance. This position may lead and direct the work of others.

• Verify and maintain compliance with ISO and cGMP quality system requirements.

• Serve as QA Subject Matter Expert (SME) for validation, equipment qualification, facilities, and associated quality systems.

• Review and approve qualification and validation protocols and reports.

• Provide QA oversight for cleaning validation, equipment calibration and maintenance, OOTs, periodic reviews, and related documentation.

• Provide real-time quality support to Operations and Quality Control teams to address compliance-related issues.

• Make independent quality decisions based on regulatory and compliance expertise.

• Provide oversight and approval of CAPAs, deviations, investigations, OOTs, and change control records.

• Perform quality system activities within DMS, LIMS, and TrackWise (Change Control, CAPA, Deviations, Investigations).

• Act as a customer and regulatory interface during audits, inspections, and meetings.

• Represent the QA department in internal and external audits and regulatory inspections.

• Support documentation updates, quality projects, and continuous improvement initiatives.

• Lead or support gap analyses, mitigation plans, and ad hoc quality improvement projects.

• Maintain site compliance with approved quality systems, regulatory requirements, industry standards, and customer expectations.

• Perform other duties as assigned.

What we are looking for:

• Minimum of 7 years of relevant work experience in Quality Assurance, validation, quality systems, or regulated biopharmaceutical/manufacturing environments.

• Bachelor’s degree (BS) in a scientific, engineering, or related technical discipline is required.

• Strong technical writing, review, and documentation skills.

• Extensive knowledge of cGMPs, ISO standards, FDA regulations, and Quality Unit requirements.

• Demonstrated expertise in Computer system validation & Equipment qualification

• Ability to independently review and approve validation protocols and reports.

• Strong working knowledge of manufacturing quality systems (manufacturing, packaging, facilities, critical systems, validation).

• Proficiency with MS Office tools (Word, Excel, Adobe, Visio).

• Experience with Quality Systems such as Document Management Systems and TrackWise QMS.

• Proven ability to manage multiple priorities in a fast-paced environment.

• Strong project planning, execution, and collaboration skills.

• Proactive, innovative, and resourceful mindset with a focus on continuous improvement.

• Ability to guide, coach, and mentor others while fostering a strong Quality Culture.

• Highly self-accountable with the ability to meet deadlines or proactively communicate and resolve obstacles.

• Experience interacting with FDA or other regulatory agencies is strongly preferred.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, ou