Lead Principal Specialist, QA Batch Review

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 (e ), 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, Pharm
  
  D) 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…