Lead Principal Specialist, QA Batch Review
$78,000–$92,000 year
On-site · Costa Mesa, California, United States
Job Summary
Lead Principal Specialist overseeing the end-to-end batch record review function in a CDMO setting, acting as the primary SME for batch record review practices. Drive quality improvements, lead regulatory inspection readiness, and provide technical leadership to the specialist team. Responsibilities include overseeing daily workflow, final review of complex batch records, developing standardized tools, establishing KPIs, risk management, CAPA and deviation handling, change control, and cross-functional collaboration for regulatory readiness and client support. Requires expert knowledge of cGMP, FDA/EMA inspections, and eQMS systems; strong leadership without formal supervisory authority; and ability to mentor junior staff and drive process optimization across manufacturing, QC, regulatory, and supply chain domains.
Required Qualifications
- Bachelor’s degree in biology, chemistry, pharmaceutical sciences, engineering, or related field
- 8–12 years of progressive QA batch-Record review or product release experience in GMP-regulated environment
- Minimum 3 years of technical leadership in QA operations or batch record review
- Extensive experience supporting FDA/EMA/client regulatory inspections
- Experience with electronic systems and eQMS platforms (MasterControl preferred)
- Mastery of cGMP regulations (US 21 CFR Parts 210/211, EU GMP Annex 1/15, ICH Q7/Q10) and manufacturing processes
- Proven track record of leading CAPA, investigations, and regulatory inspection responses
- Strong communication skills and ability to present to senior management and clients
- Strong project management skills and ability to manage multiple priorities
- Proficiency in continuous improvement tools (Six Sigma, Lean, PDCA, FMEA)
- Ability to translate regulatory requirements into practical procedures
- Integrity and sound judgment in quality leadership
- Proficiency in eQMS platforms and Microsoft Office suite
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