Johnson Service Group (JSG) is seeking a Quality Control Director for our CMO life sciences, molecular diagnostics, and medical device manufacturing client in Carlsbad, CA. This is an exciting opportunity to join a growing manufacturing organization supporting innovative diagnostic and life sciences products.
Direct Hire | Onsite | $195 - $205K
Summary
Reporting to executive leadership, the Director of Quality Control is responsible for overseeing all Quality Control laboratory operations, including Chemistry and Microbiology programs. This role provides strategic and hands-on leadership for laboratory operations, regulatory compliance, analytical method transfers, investigations, and team development. The Director will partner cross-functionally to ensure product quality, operational excellence, and compliance with FDA, GMP, ISO, and customer requirements.
Direct Hire | Onsite | $195 - $205K
Responsibilities
Lead daily QC Chemistry and Microbiology laboratory operations
Ensure compliance with GMP, SOPs, and regulatory requirements
Oversee staffing, scheduling, training, and team development
Write and review protocols, reports, deviations, CAPAs, OOS investigations, and change controls
Manage analytical method transfers, validation, and qualification
Direct analytical instrument qualification (IQ/OQ) and maintenance
Drive continuous improvement initiatives to enhance efficiency and compliance
Support strategic planning and organizational growth
Lead quality investigations and ensure data integrity
Manage client audits, regulatory inspections, and customer interactions
Recruit, mentor, and develop high-performing Quality Control teams
Collaborate with cross-functional teams to support manufacturing and quality objectives
Qualifications
Bachelor's, Master's, or Ph.D. in Chemistry, Microbiology, Molecular Biology, Biochemistry, or related Life Science field
10+ years of progressive Quality Control leadership experience within medical device, diagnostics, pharmaceutical, or life sciences manufacturing
Experience in FDA-regulated manufacturing environments
Strong background leading Chemistry and Microbiology laboratories
Extensive knowledge of ISO 13485, ISO 14971, GMP, GLP, QSR, ICH guidelines, and 21 CFR Part 820
Experience with analytical method validation, stability programs, CAPA, deviations, and OOS investigations
Experience qualifying analytical instrumentation (IQ/OQ)
Proven experience leading FDA, customer, and regulatory audits
Strong leadership, communication, and team development skills
Ability to drive strategic initiatives while maintaining a hands-on leadership approach
Excellent problem-solving, organizational, and interpersonal skills
*D800
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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