Senior Quality Program Specialist
$95,000–$153,000 year
On-site · Walkersville, Maryland, United States
Job Summary
The Senior Quality Program Specialist is responsible for ensuring compliance with ISO and cGMP quality system requirements as a Quality Assurance Subject Matter Expert (SME). The role includes independent quality oversight, support for operations and quality control teams, and involvement in audits, inspections, and continuous improvement initiatives. Successful candidates will have a minimum of 7 years in Quality Assurance, a Bachelor’s degree in a relevant field, and expertise in cGMP and ISO standards. Skills in technical writing, project planning, and the ability to manage priorities in a fast-paced environment are essential. Candidates should be proactive thinkers with a focus on fostering a quality culture.
Required Qualifications
- 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
- Extensive knowledge of cGMPs, ISO standards, FDA regulations, and Quality Unit requirements
- Ability to independently review and approve validation protocols and reports
- Strong working knowledge of manufacturing quality systems
Desired Qualifications
- Strong technical writing, review, and documentation skills
- Demonstrated expertise in computer system validation and equipment qualification
- Strong project planning, execution, and collaboration skills
- Ability to guide, coach, and mentor others while fostering a strong quality culture
- Experience interacting with FDA or other regulatory agencies
Additional Requirements
- Applicant must meet all qualifications for consideration
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