Director, Quality Control

Job Description

Job Description

Job Title: Director, Quality

Job Description

This role provides Quality leadership during a pivotal period of organizational growth, balancing hands-on GMP execution with strategic Quality oversight. The Director, Quality Control oversees GMP manufacturing quality activities, drives phase-appropriate Quality governance, and ensures robust oversight of batch records, change controls, deviations, and clinical release decisions. This temporary bridge leadership position offers the opportunity to shape future Quality strategy, support progression toward late-stage development and BLA readiness, and potentially transition into a permanent role if mutually desired.

Responsibilities

• Provide executive-level Quality leadership for GMP manufacturing operations, ensuring strong oversight of Quality systems and processes.
• Review and approve batch records to ensure compliance with GMP standards, data integrity expectations, and phase-appropriate requirements.
• Lead and oversee change control review and management, ensuring changes are adequately assessed, justified, documented, and implemented in a controlled manner.
• Direct deviation review and management, including investigation oversight, root cause analysis, corrective and preventive actions, and timely closure.
• Make sound, risk-based Quality decisions that support clinical supply, patient safety, and regulatory expectations while enabling operational efficiency.
• Provide independent Quality oversight of GMP manufacturing activities while partnering closely and constructively with Technical Operations.
• Support GMP Manufacturing Quality activities, including Materials Review Board decisions and clinical release support for investigational products.
• Lead, mentor, and develop a smaller QA team, fostering a culture of accountability, operational ownership, and continuous improvement.
• Assess and manage Quality risk across ongoing manufacturing activities, applying a phase-appropriate Quality mindset aligned with clinical development stage.
• Collaborate cross-functionally with Technical Operations and other functions to ensure alignment between Quality governance and operational execution.
• Support the design, implementation, and oversight of Quality systems and validation activities appropriate for cell therapy, gene therapy, and other biologics modalities.
• Influence and contribute to Quality strategy and readiness for late-stage development and potential BLA submissions.
• Demonstrate hands-on leadership in a lean biotechnology environment, actively engaging in daily operations and decision-making.
• Communicate effectively with technical leaders, including executive stakeholders, to ensure Quality perspectives are integrated into strategic and operational plans.

Essential Skills

• Strong GMP Manufacturing Quality experience with a focus on biologics and complex modalities.
• Demonstrated expertise in batch record review for GMP manufacturing operations.
• Proven experience in change control review and management within a regulated environment.
• Extensive experience in deviation review and management, including investigations and CAPA oversight.
• Strong Quality decision-making skills grounded in risk management and regulatory expectations.
• Experience providing manufacturing quality oversight in clinical and early-stage environments.
• Quality assurance management experience with the ability to lead and mentor smaller QA teams.
• Ability to provide independent Quality oversight while effectively partnering with Technical Operations.
• Phase-appropriate Quality mindset, with clear understanding of how expectations differ between early-stage clinical and commercial organizations.
• Experience with Quality systems and validation activities in GMP settings.
• Experience in biological sciences or related field, with familiarity in cell therapy, gene therapy, and biologics manufacturing.
• Strong communication skills and the ability to influence cross-functional teams and stakeholders.
• Ability to balance operational execution needs with robust Quality governance in a fast-paced environment.
• Capability to transition into permanent employment if mutually agreed.

Additional Skills & Qualifications

• Preference for experience in cell therapy manufacturing environments.
• Preference for experience in vector production and gene therapy operations.
• Preference for experience with monoclonal antibodies and other bioprocessing environments.
• Understanding of clinical development pathways and the transition toward late-stage development and BLA readiness.
• Experience working with Quality systems in lean biotechnology organizations.
• Demonstrated ability to operate effectively in paper-based Quality process environments.
• Strong cross-functional collaboration skills, particularly with Technical Operations and manufacturing teams.
• Comfort working in highly visible roles that require direct interaction with technical and executive leadership.

This is a Contract position based out of Redwood City, CA.

The pay range for this position is $90.00 - $110.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Redwood City,CA.

This position is anticipated to close on Oct 3, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.