Senior Quality Program Specialist

Lonza•Walkersville, MD

1d•$95,000 - $153,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.