Head Of Quality Assurance

Nicole Contreras Consulting provided pay range

This range is provided by Nicole Contreras Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Type: Full-Time, Direct Hire

NCC Talent Solutions is proud to partner with a growing CDMO biotech startup in San Diego to identify a Head of Quality who will play a critical leadership role in building, scaling, and safeguarding the company’s Quality function during an exciting phase of growth.

This is a high-impact opportunity for a quality leader who enjoys rolling up their sleeves, setting standards, and serving as a strategic partner to the business while ensuring compliance with global regulatory expectations.

As the Head of Quality
, you will lead the Quality Assurance organization and serve as the primary QA representative across internal teams and external partners. You will be responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) in alignment with FDA, EMA, and ICH GMP regulations
, while supporting regulatory inspections, customer audits, and submissions.

Beyond compliance, this role is instrumental in driving operational excellence—reducing waste, improving efficiency, and embedding quality as a core business enabler as the organization scales.

• Lead, mentor, and develop the Quality Assurance team.
• Serve as the QA representative for assigned programs at the management and external stakeholder level.
• Oversee all QA programs and projects, ensuring cross-functional alignment and on-time execution.
• Provide leadership in the design and continuous improvement of QA processes, systems, tools, and organizational structures.

• Establish, implement, and maintain a robust Quality Assurance System.
• Ensure internal documentation and processes comply with applicable regulatory requirements.
• Translate evolving regulatory expectations into practical internal quality standards.
• Independently monitor and assess the effectiveness of the QMS.

• Partner closely with internal departments and external service providers to uphold quality policy.
• Own and manage the company’s documentation control system, including creation, review, approval, and maintenance of GMP documentation.
• Lead deviation management, CAPAs, and change control processes.
• Support and participate in internal audits, customer audits, regulatory inspections, and contractor audits.
• Review and approve qualification and validation plans and batch releases.

• Act as process owner for assigned quality processes, including regular review and optimization of processes.
• Ensure appropriate training and readiness of impacted employees.
• Stay current on regulatory trends, guidance, and industry best practices.
• Serve as the primary point of contact during audits and inspections.

• Bachelor’s degree (or higher) in Pharmacy, Biotechnology, Natural Sciences, Engineering, or a related field, or equivalent professional experience.

• Minimum of 5 years of experience in Quality Assurance in a GMP-regulated environment, preferably with experience with aseptic processing.
• Strong working knowledge of bioprocessing, manufacturing, and analytical operations
  .
• Demonstrated leadership or people-management experience.
• Experience supporting regulatory inspections and audits.

• Strong written and verbal communication skills in English.
• Ability to balance strategic thinking with hands‑on execution in a fast‑paced, growth‑stage environment.

This is a rare opportunity to shape the Quality function from the ground up within a growing CDMO, with direct influence on compliance, culture, and long‑term success. The Head of Quality will be a trusted leader and partner to the business, with visibility, autonomy, and the ability to make a lasting impact.

NCC Talent Solutions is managing this search on behalf of our client. All inquiries and applications will be handled with discretion.

• Director

• Full‑time

• Quality Assurance

• Business Consulting and Services