Quality Assurance At--Source Specialist, Cell Therapy

Provides independent, visible Quality Assurance leadership at the source of cell therapy manufacturing. This is a shift-based role scheduled for four days per week, Wednesday through Saturday. Partners with Manufacturing and supporting functions to apply risk-based quality judgment, resolve issues within established frameworks, and support reliable, compliant execution. Operates independently across qualified routine and moderately complex situations, influences cross-functional decisions, and strengthens quality culture through practical coaching, clear communication, and disciplined follow-through.

Specific quality-system responsibilities and approval authorities are defined through applicable procedures, qualifications, and delegated authority.

This is a shift-based role scheduled four days per week, Wednesday through Saturday.

• Maintain a consistent Quality presence in manufacturing areas and provide real-time, practical guidance that supports safe, compliant, and reliable execution.
• Support manufacturing unit operations from a Quality Assurance perspective and assist to resolve manufacturing events and/or quality events in real-time.
• Independently assess routine and moderately complex quality situations, integrate available facts and risk considerations, and determine appropriate action or escalation within established standards.
• Partner across functions to clarify requirements, align decisions, remove barriers, and sustain appropriate Quality independence.
• Recognize emerging risks, recurring issues, and performance gaps; communicate implications and recommend proportionate actions.
• Lead defined problem-solving and improvement activities, ensuring decisions are evidence-based, clearly documented, and carried through to effective resolution.
• Coach colleagues on quality thinking, disciplined execution, data integrity, contamination control, and right-first-time behaviors.
• Contribute quality judgment to operational meetings, shift handoffs, readiness discussions, and cross-functional decision forums.
• Manage multiple priorities independently, communicate changes in risk or urgency, and maintain reliable follow-through in a fast-paced patient-focused environment.
• Support inspection readiness and represent Quality confidently within the scope of training, experience, and delegated authority.
• Work a shift-based schedule of four days per week, Wednesday through Saturday, and support occasional off-hours or holidays as needed for manufacturing operations and patient commitments.
• The role may require additional responsibilities as necessary.

• Bachelor's degree in Science, Engineering, Quality, or a related technical field with relevant GMP quality or manufacturing experience; equivalent combinations of education and experience may be considered in accordance with the approved job catalogue.
• Demonstrated ability to work independently in a regulated environment and apply cGMP principles to real-time operational decisions.
• Sound risk-based judgment, including the ability to distinguish routine issues from situations requiring broader escalation.
• Ability to lead defined problem-solving, synthesize facts, recommend actions, and communicate decisions clearly.
• Strong cross-functional collaboration and influencing skills, including respectful challenge and practical coaching.
• Ability to organize competing priorities and deliver high-quality work with limited day-to-day supervision.
• Ability to gown and work in controlled manufacturing environments.
• Ability to work the established four-day Wednesday-through-Saturday shift schedule and meet the additional scheduling requirements of the role.

• Experience in biologics, aseptic…