Job Description:
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 - $205KSummaryReporting 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 - $205KResponsibilitiesLead 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 Experience managing third-party contract 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.
