Senior Specialist, QA Program Management
$60,000–$88,000 year
On-siteSyracuse, New York, United States
Job Summary
Execute assigned QA activities for new product introductions, technical transfers, and lifecycle management in accordance with cGMP requirements. Review documentation for alignment with Quality Agreements and site procedures, identifying gaps and recommending actions or client notifications. Draft, review, and maintain Quality Agreements while driving execution of client-specific change control activities including impact assessments and action tracking. Perform QA review of site deviations and CAPAs, supporting investigations and timely closure. Provide manufacturing Quality oversight to ensure adherence to GMP and operational standards. Participate in inspection and audit readiness activities, serving as a QA representative during audits as assigned. Collaborate with cross-functional teams to communicate QA expectations and support timely completion of deliverables.
Required Qualifications
- Bachelor's degree in Biotechnology, Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related discipline
- Minimum of 2-4 years of experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, or CDMO environment
- Experience in Quality Assurance, Quality Systems, Manufacturing Quality, Program Management, or related functions
- Ability to interpret and apply phase-appropriate cGMPs, regulatory requirements, and industry best practices
- Problem-solving skills, attention to detail, and analytical thinking
- Ability to manage multiple assigned tasks and priorities simultaneously
- Ability to collaborate cross-functionally and contribute to team-based decision-making in a matrixed environment
- Ability to analyze and interpret data, apply risk-based quality principles, and support sound, compliant decision-making
- Strong written and verbal communication skills
- Commitment to maintaining and promoting a safe and compliant work environment
- Less than 5% of travel is required for this position
- East Syracuse, NY
Desired Qualifications
- Experience supporting quality systems and compliance activities, which may include: deviations, CAPAs, change controls, investigations, document management, validation, technical transfers, and new product introductions (NPI)
- Hands-on experience with an electronic Quality Management System (eQMS)
- Experience with Veeva Vault Quality/QualityOne
- Experience with equivalent systems such as TrackWise, MasterControl, ETQ, or similar platforms
- Experience interacting with clients, regulatory agencies, and cross-functional stakeholders in a GMP-regulated environment
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