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 - $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
- 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
** 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.
Numbers & Facts
| Location | Carlsbad, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $195,000–$205,000 Per Year |
| Company Size | 1,000 to 1,499 employees |
| Year Founded | 1984 |
| Website | https://www.jsginc.com/ |
About Company
At JSG, We Understand People
It is our mission to empower people, help our clients reach their goals, and hire motivated individuals.
Since our start in 1984, we’ve worked hard to establish our present position as the most effective cross-industry staffing and consulting solution available.
Headquartered in Chicago, IL with local offices throughout the United States and Canada, JSG proudly serves a diverse range of industries with the right solutions to help clients reach their company goals. Our client-centric approach enables us to create personalized solutions for businesses in need of top-tier talent. Our dedication doesn’t stop at our clients. We strive to connect candidates with opportunities that match their skills and goals. More than just a go-between, we are a dependable bridge, uniting top talent with suitable opportunities, facilitating shared opportunities and growth.
Skills
- Analysis Skillsunmatched
- Analytical Method Validationunmatched
- Auditingunmatched
- Biochemistryunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Business Strategyunmatched
- Change Controlunmatched
- Chemistryunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Customer Relationsunmatched
- Data Qualityunmatched
- FDA (Food and Drug Administration)unmatched
- GLP (Good Laboratory Practices)unmatched
- GMP (Good Manufacturing Practices)unmatched
- ICH Regulationsunmatched
- ISO (International Organization for Standardization)unmatched
- Instrumentationunmatched
- Interpersonal Skillsunmatched
- Laboratoryunmatched
- Laboratory Managementunmatched
- Laboratory Operationsunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Medical Diagnosisunmatched
- Medical Equipmentunmatched
- Mentoringunmatched
- Microbiologyunmatched
- Molecular Biologyunmatched
- Organizational Skillsunmatched
- Problem Solving Skillsunmatched
- Process Improvementunmatched
- Process Validationunmatched
- Quality Controlunmatched
- Quality Managementunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Sales Managementunmatched
- Standard Operating Procedures (SOP)unmatched
- Strategic Planningunmatched
- Team Buildingunmatched
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