NCC Talent Solutions, LLC · 1 week ago
Head of Quality Assurance
San Diego, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$130K/yr - $150K/yr
5+ years expNCC Talent Solutions is partnering with a growing CDMO biotech startup in San Diego to identify a Head of Quality who will play a critical leadership role in building and scaling the company’s Quality function. This role involves leading the Quality Assurance organization, ensuring compliance with global regulatory expectations, and driving operational excellence as the organization grows.
Management Consulting
Hiring Manager
Nicole Contreras, SPHR
Responsibilities
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, 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
Qualification
Required
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
Company
NCC Talent Solutions, LLC
At Nicole Contreras Consulting, we partner with organizations to transform their Talent Acquisition function into a true strategic advantage.
0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase