The Sr. Specialist or Principal, Quality Assurance is responsible for providing Quality oversight and leadership across product lifecycle activities in a cell therapy environment. This role partners closely with Manufacturing, MSAT, Process Development, and Regulatory to support process implementation, technology transfer, process improvements, process validation, and commercialization efforts including regulatory submission support for submission(s).

The incumbent will serve as a Quality representative on cross-functional project teams, ensuring that product-related activities are executed in compliance with GMP requirements while supporting timelines for clinical and commercial milestones.

KEY ROLES AND RESPONSIBILITIES:

• Process Validation & Product Lifecycle Support (PPQ) for Lenti Viral Vector (LVV), Plasmids and Drug Product(s):
• Provide CDMO Quality oversight for process validation (PPQ) activities, ensuring execution aligns with approved protocols, GMP requirements, and regulatory expectations.
• Review and approve validation protocols, reports, and supporting documentation (e.g., risk assessments, sampling plans, acceptance criteria, specifications).
• Partner with CDMO, MSAT, and Process Development to define PPQ and validation strategies, ensuring they are robust and include evaluation of critical process parameters (CPPs), critical quality attributes (CQAs), and in-process controls.
• Provide Quality oversight during PPQ execution on the manufacturing floor, ensuring adherence to protocols and real-time issue escalation.
• Assess PPQ data for completeness, accuracy; ensure conclusions are justified and support process validation.
• Ensure deviations occurring during PPQ and validation are appropriately investigated, documented, and resolved with minimal impact to timelines.
• Ensure alignment between validation activities and regulatory filings (IND/BLA), including traceability between executed studies and submitted data.

Regulatory Strategy, BLA Support & Inspection Readiness:

• Act as the Quality representative on cross-functional project teams supporting product development, tech transfer, process validation, IND support, and commercialization activities.
• Serve as Quality Subject Matter Expert (SME) for IND and BLA coordination activities, ensuring consistency between Quality documentation and regulatory submissions.
• Author and review CMC sections of regulatory submissions to ensure accuracy, completeness, and compliance with GMP requirements.
• Ensure all validation, manufacturing, and quality documentation is inspection-ready and supports regulatory filings and commitments.
• Drive continuous improvement initiatives to enhance process robustness, validation effectiveness, and inspection readiness.
• Lead cross-functional readiness activities to ensure the manufacturing site is prepared for regulatory inspections as applicable.
• Provide Quality oversight for deviations, CAPAs, and change controls, as applicable.

KNOWLEDGE SKILLS AND ABILITIES:

• Experience in cGMP clinical manufacturing required.
• Experience with Plasmid and LVV manufacturing strongly preferred.
• Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
• Proven capability to oversee QA operations and workflows, ensuring timely execution, compliance, and alignment with organizational priorities.
• Ability to work effectively both independently and cross-functionally with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results.
• Excellent communication, emotional intelligence and interpersonal skills.
• Curious and proactive mindset with a continuous improvement orientation; actively seeks to understand processes, identify risks, and implement sustainable quality solutions.
• Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
• Excellent analytical skills and scientific/technical expertise.

PREFERRED EDUCATION:

• Principal - BS with a minimum of 15 years experience in biochemistry, chemical engineering, bioengineering, or related scientific field; or
• Sr. Specialist - BS with a minimum of 10 years experience in biochemistry, chemical engineering, bioengineering, or related scientific field; or

PREFERRED EXPERIENCE:

• 10-15 years of experience in GMP biopharmaceutical operations including 4 years in cell therapy and/or lentiviral manufacturing operations.
• Minimum of 5+ years in Quality Assurance.
• Direct experience supporting BLA submissions, regulatory filings, and/or health authority inspections.
• Experience in commercial manufacturing and post-approval lifecycle management.

PHYSICAL REQUIREMENTS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.

SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:

Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will occasionally be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients