Job Description

About the job

Location: San Diego, CA (Onsite)

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.

About the Role

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.

Key Responsibilities:

Leadership & Strategy

• 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.

Quality Systems & Compliance

• 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.

Operational Quality Oversight

• 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.

Process Ownership & Continuous Improvement

• Act as process owner for assigned quality processes, including:
• Regular review and optimization of processes
• Ensuring appropriate training and readiness of impacted employees
• Staying current on regulatory trends, guidance, and industry best practices
• Serving as the primary point of contact during audits and inspections

Desired Qualifications

Education

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

Experience & Expertise

• 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.

Skills

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

Why This Role

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.

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