QA Team Lead / Senior Quality Assurance Specialist

About the role

The QA Team Lead / Senior Quality Assurance Specialist will support Quality Assurance Operations activities within a GMP cell and gene therapy manufacturing environment. This position will provide on-the-floor and operational QA support, with primary responsibilities including batch record review, deviation and investigation support, documentation review, manufacturing support, quality oversight, and ensuring compliance with company procedures, cGMP requirements, and applicable regulatory expectations.

The Senior QA Specialist / QA Lead will serve as a key Quality representative during assigned shifts and will provide day-to-day QA leadership and oversight of manufacturing and QC activities, particularly during weekend operations. The role will provide real-time quality guidance, assess and escalate compliance risks, support quality decision-making, and ensure issues are appropriately documented, investigated, and resolved.

The QA Team Lead / Senior Quality Assurance Specialist will work closely with Manufacturing, Quality Control, Engineering, Facilities, Supply Chain, and other cross-functional teams to ensure activities are performed in accordance with approved procedures and GMP requirements. The position will play an important role in supporting timely batch disposition, maintaining GMP compliance, identifying and mitigating quality risks, and ensuring effective communication and escalation of quality issues.

This role will primarily support weekend manufacturing and QC operations and requires a strong understanding of GMP principles, excellent attention to detail, sound judgment, leadership capabilities, and the ability to make appropriate quality decisions in a fast-paced CDMO environment.

What you'll do

• Provide QA support to GMP manufacturing operations during the assigned weekend shift.
• Serve as a Quality presence on the manufacturing floor and provide real-time guidance on GMP and procedural requirements.
• Serve as the primary QA point of contact for manufacturing and QC activities during the assigned shift.
• Perform detailed batch record review for accuracy, completeness, and compliance with GMP standards.
• Support the QA team in managing and executing deviation investigations, including root cause analysis and CAPA development.
• Ensure timely review and approval of executed manufacturing documents.
• Collaborate with Manufacturing, QC, and other cross-functional teams to resolve documentation discrepancies.
• Support QA review of logbooks, controlled forms, and other GMP documentation.
• Ensure documentation complies with Good Documentation Practices (GDP), ALCOA+ principles, and data integrity expectations.
• Ensure appropriate QA coverage, communication, and handoff between weekend and weekday operations.
• Assist in preparing QA documentation for audits, inspections, and regulatory submissions.
• Maintain accurate QA records and documentation in compliance with internal procedures and regulatory requirements.
• Participate in continuous improvement initiatives for documentation and review processes.
• Support QA on the floor activities, as needed, including line clearance and room release.

Qualifications

• Bachelor's degree in business, life sciences, Pharmaceutical Sciences, or a related field.
• 7 + years of experience working in a GMP-regulated environment, preferably within cell and gene therapy, biologics, pharmaceutical manufacturing, or a CDMO.

• Hands-on experience with batch record review, QA Operations, deviation management, or investigations.

• Strong understanding of FDA, EMA, and ICH GMP requirements applicable to pharmaceutical and biologics manufacturing.

• Strong knowledge of Good Documentation Practices (GDP), ALCOA+ principles, and data integrity expectations.

• Experience working in a CDMO environment with multiple client programs and rapidly changing priorities.

• Familiarity with risk management tools such as FMEA and Quality Risk Management (QRM).

• Ability to identify potential quality risks and exercise sound judgment when making or escalating quality decisions.
• Ability to act as a QA Lead and decision-maker during assigned shifts.

• Ability to prioritize multiple quality and operational activities in a fast-paced environment.

• Ability to provide coaching and GMP guidance to junior QA personnel and cross-functional teams.

• Ability to effectively manage competing priorities while maintaining Quality independence and compliance.

• Demonstrated ability to recognize emerging compliance risks and proactively engage in appropriate QA leadership.

• Strong ownership, accountability, and commitment to maintaining a robust GMP quality culture.

• Strong written and verbal communication skills.

• Prior experience with batch record review, QA operatins, or deviation investigations.

• Experience working with electronic quality management systems such as Veeva, MasterControl, TrackWise, or similar platforms.

• Experience in a cell therapy, gene therapy, or aseptic manufacturing environment is a plus.