QA Operations Leader – cGMP & FDA Compliance

Smart Media; Manassas (VA); On-site; USD 110,000 - 140,000; Full time

Job summary

Smart Media in Manassas, VA is seeking a QA Manager to ensure cGMP compliance and oversee quality system documentation across the site. This onsite role requires leadership of QA staff, coordination with Regulatory Affairs, and ensuring timely product disposition.

You will lead audits, CAPA development, change control, and training, while maintaining records such as batch records and validation documents. The ideal candidate has 6+ years in QA within pharma, a life sciences degree, and strong

Qualifications

• Expert knowledge of cGMP and FDA guidance applicable to pharmaceutical manufacturing.
• Experience writing and maintaining cGMP documentation and procedures.
• Strong analytical and cross-functional communication skills.

Responsibilities

• Lead QA documentation activities in line with cGMP and SOPs and facilitate regulatory compliance.
• Manage quality operations including inspections, release timelines, and product disposition.
• Coordinate internal/external audits and maintain site audit readiness.
• Develop CAPAs, changes controls, and review validation/documentation work products.
• Provide QA support for batch records, stability reports, and regulatory submissions.

Skills

cGMP knowledge

FDA regulations

Documentation

Leadership

Cross-functional teamwork

MS Office

Education

Bachelor's degree in life sciences

Master's degree (preferred)

Tools

Adobe

Microsoft Office

Job description

Smart Media in Manassas, VA is seeking a QA Manager to ensure cGMP compliance and oversee quality system documentation across the site. This onsite role requires leadership of QA staff, coordination with Regulatory Affairs, and ensuring timely product disposition.

You will lead audits, CAPA development, change control, and training, while maintaining records such as batch records and validation documents. The ideal candidate has 6+ years in QA within pharma, a life sciences degree, and strong