Sr. Manager, Quality
$165,000–$185,000 year
On-site · Harmans, Maryland, United States
Job Summary
Lead GMP readiness and quality oversight for a plasmid DNA manufacturing facility, driving QA/QC systems, deviations, CAPA, change control, batch release, document management, and training. Serve as QA lead for plasmid manufacturing operations with on-the-floor support during critical manufacturing steps, oversee QC methods and testing programs, and lead inspection readiness and regulatory interactions. Build and develop a high-performing QA/QC team, partner with Manufacturing, MS&T, Facilities/Engineering, Regulatory, and Supply Chain to resolve quality issues, and drive continuous improvement using quality metrics and risk management. Requires Master’s degree (or BA with extended QA/QC experience) and 6+ years (or 8+ years with BA) of relevant experience, plus 5+ years of leadership. On-site role in Harmans, MD with 8–5 schedule; salary range $165,000–$185,000 plus bonus.
Required Qualifications
- Master’s degree in Scientific, Engineering, or Biotech discipline with minimum 6 years QA/QC experience in biologics/regulated industry OR Bachelor's degree with 8+ years QA/QC experience in biologics/regulated industry
- 5+ years progressive leadership and direct management experience
- proficiency with electronic quality systems (LIMS, MasterControl, TrackWise) preferred
- solid understanding of biologics manufacturing processes (fermentation, purification, contamination control, and segregation); plasmid DNA manufacturing experience preferred
- ability to work independently and in a team-based environment under tight timelines
- excellent communication and people leadership skills for cross-functional collaboration and regulatory interactions
Desired Qualifications
- Master’s degree in Scientific, Engineering, or Biotech discipline (preferred) with 6+ years QA/QC in biologics/regulated industry; or Bachelor's in Scientific/Engineering/Biotech with 8+ years QA/QC in biologics/regulated industry
- 5+ years progressive leadership and direct management experience
- experience with electronic quality systems (LIMS, MasterControl, TrackWise preferred)
- strong analytical, troubleshooting, and decision-making skills in GMP environment
- ability to lead inspections and regulatory interactions
- excellent communication and people leadership skills
- facility/portfolio experience in plasmid DNA or gene therapy manufacturing is a plus
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