Lead Principal Specialist, QA Batch Review

Lead Principal Specialist, QA Batch Review Full Time Costa Mesa, CA, US Salary Range: $68,000.00 To $85,000.00 Annually

POSITION SUMMARY:

Expert‑level individual contributor and technical team lead responsible for overseeing the end‑to‑end batch record review function, ensuring timely, consistent, and compliant review and release of batch production records across all product campaigns in a CDMO environment. Serves as the primary SME and internal authority for batch record review practices, drives strategic quality improvements, leads regulatory inspection readiness, and provides technical leadership and day‑to‑day guidance to the specialist team without formal supervisory authority.

PRINCIPAL DUTIES:

Technical Leadership & Batch Record Oversight Serve as the primary technical authority for batch record review, providing expert‑level guidance on complex, novel, or high‑risk review scenarios. Oversee and coordinate the daily workflow of the batch record review team to ensure review timelines align with manufacturing, supply chain, and client release schedules. Conduct and approve final review of the most complex or critical batch records, providing second‑level quality check for high‑risk campaigns. Develop and maintain standardized review tools, checklists, and reference aids to ensure consistency across all specialists. Establish and drive quality metrics (KPIs) for batch record review performance, lead root cause analysis for review cycle time deviations or quality escapes. Ensure batch record review practices remain aligned with current regulatory expectations and industry best practices. Quality Systems & Risk Management Lead the identification, investigation, and disposition of complex deviations, OOS/OOT events, and CAPA actions related to batch record review. Approve CAPA closure and verify effectiveness checks for systemic batch record issues. Lead risk assessments related to batch record review processes and implement risk‑mitigation strategies. Oversee change control evaluation and approval for processes impacting batch record review. Proactively identify cross‑functional quality risks and lead mitigation across manufacturing, QC, regulatory, and supply chain teams. Regulatory Inspection Readiness & Client Support Serve as primary SME and lead spokesperson for batch record review during FDA, EMA, and client audits and inspections. Prepare and present inspection‑readiness summaries and technical briefings to QA management and site leadership. Lead preparation of inspection responses (483s, Warning Letter responses) related to batch record review findings. Serve as QA point of contact for client‑specific batch record review requirements and queries. Represent QA Batch Review in cross‑functional project teams, product launches, and regulatory submissions. SOP Development & Training Program Ownership Author, revise, and approve SOPs, work instructions, and training materials related to batch record review and product release. Design and deliver structured training and competency programs for all levels of specialists. Mentor Senior Specialists in leadership skills and technical depth; coach junior specialists on core competencies. Identify training gaps and implement corrective training plans in response to review trends or audit findings. Process Optimization & Strategic Initiatives Lead cross‑functional initiatives to streamline batch record review processes, reduce cycle times, and improve first‑pass quality. Champion the adoption of digital tools, electronic batch records (eBR), and eQMS enhancements to improve review efficiency. Contribute to departmental strategy for scaling batch record review capabilities to support business growth and new product campaigns. Collaborate with manufacturing, R&D, regulatory affairs, and supply chain to ensure quality is embedded throughout the product lifecycle. May perform other duties as assigned.

QUALIFICATIONS AND EXPERIENCE:

Bachelor’s degree in biology, chemistry, pharmaceutical sciences, engineering, or related field required; advanced degree (MS, PharmD) preferred. 8–12 years of progressive experience in QA batch record review and/or product release in a GMP‑regulated pharmaceutical, biotech, or CDMO environment. Minimum 3 years of demonstrated technical leadership experience within a batch record review or QA operations function. Extensive experience supporting FDA, EMA, and/or client regulatory inspections as a subject matter expert. Experience with electronic systems and eQMS platforms strongly preferred. Recognized expert in cGMP regulations (US 21 CFR Parts 210/211, EU GMP Annex 1/15, ICH Q7/Q10) and pharmaceutical/biopharmaceutical manufacturing processes. Mastery of quality systems: Deviation, CAPA, Change Control, OOS/OOT, Document Control, Risk Management, and Product Release. Proven track record of leading complex quality investigations, CAPA programs, and regulatory inspection responses. Demonstrated ability to provide technical leadership and influence without formal authority. Exceptional communication skills; ability to present to senior management, clients, and regulatory agencies with confidence. Strong project management skills; able to manage multiple priorities and deadlines in a fast‑paced CDMO environment. Advanced proficiency in continuous improvement tools (Six Sigma, Lean, PDCA, FMEA). Ability to translate regulatory requirements and industry guidance into practical, compliant operational procedures. Must demonstrate unwavering integrity, sound judgment, intellectual honesty, and an uncompromising dedication to quality. Proficient in eQMS platforms (e.g., MasterControl), electronic systems, and Microsoft Office Suite. #J-18808-Ljbffr Pyramid Laboratories