Director, Quality Control

Responsibilities

• Establishes and maintains effective oversight of external contract testing laboratories, serving as the primary QC subject-matter expert. This includes conducting on-site evaluations to assess technical capability, compliance status, and quality performance, and ensuring alignment with internal standards and regulatory expectations.
• Provides direct leadership for QC contributions to regulatory submissions, including INDs and BLAs. Accountable for authoring and/or reviewing QC-related sections of submissions, with specific ownership of stability strategies, specification strategies, and batch analysis data. This includes performing gap assessments, identifying and communicating risks, and providing clear recommendations to Quality Management to support robust stability and specification programs.
• Manages QC inspection readiness and plays a lead role in regulatory inspections, including developing and maintaining inspection task mapping, preparing teams and partners for inspections, interfacing directly with health authorities as appropriate, and ensuring timely and effective responses to inspection findings.
• Serves as technical SME and provides oversight of all analytical method activities including method transfers, method qualification/validation, and compendial method verification. Reviews and approves qualification/validation protocols, executed data packages, and reports.
• Oversight of day-to-day activities including ensuring completion and maintenance of all required GxP, and company-mandated training; establishing recurring QC governance forums with defined agendas; ensuring accurate documentation of decisions and action items; and driving issues to resolution.
• Leads the development, maintenance, oversight, and continuous improvement of QC policies, procedures, processes, and tools. This includes release testing, stability program management, sample management and traceability, reference/standard program, critical reagents program, sample retains, analytical equipment qualification and maintenance, etc. across programs and lifecycle stages.
• Serves as main point of contact for OOS/OOT lab investigations. Provides guidance and strategy on impact, closure, and prevention.
• Builds, leads, and develops high-performing QC teams including setting clear expectations, mentoring senior staff, supporting succession planning, and fostering a culture of quality, accountability, and continuous improvement across both internal teams and external partners.
• Responsible for strategic planning related to QC staffing, capabilities, and infrastructure. This includes making recommendations on resource allocation, capital expenditures, and inspection capabilities to support current and future program needs.
• Prepares and delivers regular updates to the Technical Operations Leadership Team and other senior stakeholders on QC performance, metrics, trends, and risks. Following leadership alignment, the Director, QC drives execution of agreed-upon actions across Technical Operations and cross-functional teams, with clear timelines and accountability.

Qualifications

• A minimum of 10 years of progressive Quality Control experience in a biotechnology or pharmaceutical environment is required.
• A Bachelor’s degree in a scientific discipline is required; a Master’s degree or advanced scientific degree is preferred.
• Demonstrated experience supporting cellular therapy and or autoimmune disease programs is required.
• Direct, hands-on involvement in IND and BLA submissions, stability program design and execution, and regulatory inspections is required.
• Strong working knowledge of global GMP regulations, outsourced laboratory oversight models, and integrated quality systems is required.
• Proven ability to lead in a matrixed, fast-paced environment, balancing strategic leadership with operational execution.
• Exceptional verbal, written, and interpersonal communication skills, with the ability to clearly convey complex scientific and regulatory information to diverse audiences.
• Demonstrated ability to independently manage multiple priorities with sound judgment, limited oversight, and a high degree of accountability.
• A collaborative leadership style with a strong track record of partnering effectively across Technical Operations, Quality, Regulatory Affairs, and other cross-functional teams.