About the Role
Our Fairfield, NJ facility is expanding, and we are seeking a hands on Senior Quality Manager to elevate our Quality Management System (QMS) and lead the site through an upcoming FDA Pre Approval Inspection (PAI). You will be a site's quality authority-owning cGMP compliance, driving continuous improvement, and mentoring a growing QA/QC team within a nimble, fast paced API environment.
Key Responsibilities
Compliance & Audits
• Serve as site owner for all regulatory, third party, and customer audits (FDA, EMA, ISO, DEA).
• Lead PAI readiness: gap assessments, CAPA execution, mock inspections, and front room/back room strategy.
Quality Systems
• Maintain and enhance the QMS: change control, deviations, investigations, CAPA, document control, supplier qualification, and training.
• Generate and track quality KPIs; present monthly to executive leadership.
Leadership & Development
• Direct and mentor a team of QA Specialists, QC Analysts, and external consultants ( 2.5 FTEs).
• Foster a proactive, right first time culture; coach cross functional teams on GMP best practices.
Batch Release & Validation
• Approve master batch records, specifications, analytical methods, and validation protocols (process, cleaning, equipment, computer systems).
Continuous Improvement
• Drive Lean Six Sigma projects to reduce deviations, improve yield, and shorten release cycles.
• Champion data integrity (ALCOA+) across manufacturing and laboratory systems.
Risk Management
• Perform and oversee quality risk assessments (ICH Q9) and supplier audits.
Qualifications
- Education: BS/BA in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field (MS preferred).
- 5 + years' progressive QA/QC leadership in cGMP pharmaceutical or chemical API manufacturing.
- Demonstrated success preparing for and hosting FDA/EMA PAIs and routine GMP audits.
- Hands on expertise with ICH Q7, Q9, Q10, 21 CFR Parts 210/211/11, and data integrity guidelines.
- Strong track record implementing or upgrading electronic QMS/LIMS platforms.
- Technical Skills: Validation, analytical methods, deviation/CAPA management, root cause analysis
- Certifications: ASQ CQA, CPGP, or Six Sigma a plus
- Soft Skills: Influential communicator, decisive problem solver, and collaborative coach able to thrive in a high mix, small team setting.