Lead QA Specialist, Batch Records (CDMO)

Summary

Senior-level quality professional responsible for providing technical leadership and oversight of batch documentation review activities to ensure accurate, timely, and compliant disposition of manufacturing records. Acts as the primary subject matter expert for batch review processes, drives quality system improvements, supports regulatory readiness activities, and provides guidance and mentorship to quality specialists. This role serves as a key technical resource across multiple product lines and manufacturing operations.

Key Responsibilities

Technical Leadership & Batch Review Oversight

• Serve as the primary technical expert for batch documentation review, providing guidance on complex or high-risk review situations.
• Coordinate and prioritize review activities to support operational and product release timelines.
• Perform final review of complex manufacturing records and provide secondary quality review where appropriate.
• Develop and maintain standardized review procedures, tools, and reference materials to promote consistency and compliance.
• Establish performance metrics and monitor review effectiveness, identifying opportunities for process improvement.
• Investigate review-related issues and implement corrective actions to improve quality and efficiency.
• Ensure review practices remain aligned with current regulatory requirements and industry standards.

Quality Systems & Risk Management

• Lead investigations involving deviations, nonconformances, quality events, and corrective/preventive actions associated with manufacturing documentation.
• Review and approve corrective action plans and verify the effectiveness of implemented solutions.
• Conduct risk assessments and support the development of mitigation strategies for quality-related processes.
• Evaluate and approve changes that may impact documentation review, product quality, or compliance.
• Partner with cross-functional stakeholders to proactively identify and address quality risks.

Regulatory Compliance & Inspection Support

• Serve as a subject matter expert during regulatory inspections, customer audits, and internal assessments.
• Prepare inspection readiness materials and provide technical presentations to quality and site leadership.
• Support responses to inspection observations and audit findings related to documentation review processes.
• Collaborate with internal and external stakeholders to address quality and compliance inquiries.
• Represent the quality organization on cross-functional projects, process improvement initiatives, and product lifecycle activities.

Procedures, Training & Knowledge Development

• Author, revise, and approve procedures, work instructions, and training materials.
• Design and deliver training programs that support technical competency and regulatory compliance.
• Mentor quality professionals and provide coaching on technical and procedural requirements.
• Identify knowledge gaps and implement targeted training initiatives based on performance trends and audit outcomes.

Continuous Improvement & Operational Excellence

• Lead initiatives focused on improving review efficiency, reducing cycle times, and enhancing documentation quality.
• Support implementation and optimization of electronic quality and manufacturing systems.
• Contribute to long-term quality strategy and scalability initiatives.
• Collaborate across operations, quality, technical, and supply functions to promote a culture of quality throughout the product lifecycle.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree in a life sciences, engineering, or related technical discipline required; advanced degree preferred.
• 8+ years of progressive experience in quality assurance, batch documentation review, product release, or related GMP-regulated activities.
• Demonstrated experience providing technical leadership within a quality operations environment.
• Experience supporting regulatory inspections and external audits as a subject matter expert.
• Strong knowledge of electronic quality systems and document management platforms.
• Advanced understanding of global GMP regulations and regulated manufacturing processes.
• Extensive experience with quality systems including deviations, CAPA, change management, investigations, risk management, document control, and product disposition.
• Proven success leading complex investigations, compliance initiatives, and process improvements.
• Strong ability to influence stakeholders and drive outcomes across multiple functional areas.
• Excellent written and verbal communication skills with the ability to engage technical and executive audiences.
• Effective project management and organizational skills in a fast-paced environment.
• Experience applying continuous improvement methodologies such as Lean, Six Sigma, PDCA, or similar approaches.
• Ability to interpret regulatory expectations and translate them into practical operational processes.
• Demonstrated integrity, sound judgment, and commitment to quality and compliance.
• Proficiency with quality management systems and standard business software applications.

...