Senior Specialist, Quality Systems

Senior Specialist, Quality Systems

About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq.

ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

We have an opportunity for a Senior Specialist, Quality Systems to join our team. In this role, you will support Quality Systems, including investigation and deviation management, CAPA tracking, and change control. You will compile, trend, and report key quality metrics for management and other quality system functions as needed. This position ensures compliance with regulatory standards and drives quality improvements for GMP manufacturing of biological products.

Shift: Monday - Friday, 8am-430pm

Location:

Harmans, MD - BWI 100% Onsite

• Administer and support CAPA, deviation, investigation, and change control processes, ensuring timely completion, effectiveness verification, and regulatory compliance.
• Author, review, and maintain quality records including deviations, investigations, CAPAs, change controls, and GMP documentation such as SOPs.
• Track, trend, and analyze Quality System metrics, providing routine reports to management on risks, performance, and improvement opportunities.
• Conduct CAPA and change effectiveness evaluations using quantitative and qualitative data to verify sustainable outcomes.
• Maintain Quality System tracking tools and reporting mechanisms to ensure organizational visibility and accountability.
• Monitor quality systems, procedures, and compliance activities, identifying opportunities to improve regulatory adherence, efficiency, and overall quality performance.
• Support compliance remediation efforts, quality improvement initiatives, and cross-functional projects as a Quality Assurance representative.
• Develop and deliver Quality Systems training, manage user access, and promote workforce compliance with quality requirements.
• Coordinate and support internal and external audits, including audit preparation, client interactions, observation responses, and follow-up activities.
• Partner with cross-functional teams to enhance quality processes, improve system performance, and maintain ongoing professional training and operational readiness.
• Other duties as assigned.

• Master’s degree in Scientific, Engineering, Biotech, or related field with 2-4 years of experience in the biologic, pharmaceutical, or medical device industry performing hands-on work in Quality Assurance.
• OR Bachelor’s degree in Scientific, Engineering, Biotech, or related field with 4-6 years of experience in the biologic, pharmaceutical, or medical device industry performing hands-on work in Quality Assurance.

• Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 or Quality System Regulations (QSR) per 21 CFR Part 820.
• Proficiency in Microsoft applications including Excel, PowerPoint, Access, Teams, and SharePoint.
• Knowledge of biological regulations (21 CFR Part 600s) or EU GPs is a plus.
• Experience with electronic systems, including developing and producing reports.
• Experience with data analytics and related concepts.
• Ability to quickly learn and navigate new electronic systems.
• Capable of working in a team setting and independently with minimal supervision.
• Ability to work in a fast-paced environment supporting QA/QC departments of a CMO for Phase I/II/III GMP manufacturing of biologic…