We're looking for a QA Manager of Chemistry to serve as the final scientific and compliance authority on batch release for a growing pharmaceutical/compounded products organization. This is a hands-on leadership seat, not a back-office QA function — you're making the release call, defending it in the room, and shaping the team that supports it. If you want ownership over both the science and the people side of quality, this is built for that.
Responsibilities:
- Serve as QA approver for in-process, finished product, and stability batches — no product moves until the data, deviations, and investigations are fully resolved.
- Independently evaluate analytical data (assay, impurities, stability, physical testing), verifying methods, calculations, and analyst conclusions meet validated and regulatory standards.
- Review and approve OOS/OOT results, deviations, and CAPAs — ensuring root cause is real and the fix is defensible.
- Ensure batch release practices meet cGMP, FDA, and USP standards; review SOPs and drive continuous improvement in release workflows.
- Act as subject matter expert during inspections, defending disposition decisions and data review practices to regulators and clients.
- Manage scheduling and workload across the QA batch-release group, coach analysts on technical judgment, and own performance management — including readiness for surge capacity when release timelines demand it.
Qualifications:
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field (advanced degree a plus)
- 7–10 years of QA/QC experience in a regulated pharmaceutical or compounding environment
- Hands-on expertise with HPLC/UPLC, GC, KF, UV-Vis, and FTIR
- Track record of batch release, product disposition, and QA data review decisions
- 3–5+ years directly leading people in a QA or lab setting, including scheduling and workload management
- Experience owning OOS investigations, deviations, CAPA, and data integrity issues end to end
- Comfort representing your work directly to FDA inspectors and client auditors
- Strong technical writing — your documentation needs to survive scrutiny
- Familiarity with electronic QMS and LIMS systems (preferred, not required)
Pay: $95,000.00 - $120,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
