Quality Control Director

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Benefits and Pay Range

At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy:

• Medical, Dental, and Vision Insurance
• Company-Paid Life Insurance (1x Annual Salary)
• Voluntary Life Insurance Options
• Short-Term and Long-Term Disability Insurance
• Flexible Spending Account (FSA) & Health Savings Account (HSA)
• 401(k) Retirement Plan with Company Matching
• 10 Days of Paid Time Off (PTO)
• 10 Paid Holidays Annually

The pay range for this position is $195,000 - $205,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

Position Overview

The Director of Quality Control is responsible for leading and managing all aspects of laboratory operations within QC Chemistry and Microbiology programs. This role ensures compliance with Good Manufacturing Practices (GMP) and other regulatory requirements while supporting organizational growth initiatives. The Director will oversee daily operations, including scheduling, staffing, training, troubleshooting, and continuous improvement efforts.

Additionally, this position plays a critical role in managing analytical method transfers, instrument qualification, deviation investigations, and CAPA implementation. The Director will collaborate closely with cross-functional teams, providing strategic leadership in quality control while maintaining high standards of compliance, efficiency, and data integrity.

The ideal candidate will have extensive experience in regulatory compliance (ISO-13485, ISO 14971, GMP/GLP, QSR, ICH guidelines), audit management, and client communications. This individual will bring a hands-on leadership approach, fostering a culture of excellence, accountability, and continuous improvement within the Quality Control team.

This role is 100% on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• Lead and manage daily laboratory operations for QC Chemistry and Microbiology programs, ensuring compliance with SOPs, GMP, and safety regulations.
• Oversee scheduling, staffing, training, and troubleshooting to maintain efficient workflows and high-quality standards.
• Write and review protocols, reports, and investigation documentation, including deviations, OOS, CAPAs, and change controls.
• Manage analytical method transfers, including phase-appropriate qualification and validation of test methods.
• Direct instrument qualification (IOQ) and ensure proper placement and maintenance of analytical equipment.
• Develop and implement process improvements to enhance efficiency, compliance, and data integrity.
• Support strategic planning, team development, and professional growth initiatives.
• Ensure objective product quality assessments through accurate and timely data generation.
• Lead audits, client interactions, and regulatory inspections, providing technical expertise and compliance assurance.
• Recruit, mentor, and develop a high-performing quality control team, fostering a culture of accountability and excellence.

Requirements and Qualifications

• Bachelor's, Master's, or Ph.D. in a Life Science discipline (e.g., Chemistry, Microbiology, Molecular Biology, or Biochemistry).
• 10+ years of progressively increasing leadership experience in the medical device or pharmaceutical industry.
• Proven track record in FDA-regulated environments, including direct involvement with audits from the FDA, regulatory agencies, and clients.
• Experience managing 3rd-party contract laboratories.
• Strong analytical background in Chemistry and Microbiology, with the ability to execute objective and thorough OOS (Out of Specification) and failure investigations.
• Experience in a growth-oriented, contract manufacturing organization with a focus on compliance.
• Demonstrated success in strategic planning, process improvements, and professional development initiatives.
• In-depth knowledge of ISO-13485, ISO 14971, GMP/GLP, QSR, ICH Q1A/Q2, and 21 CFR 820.30.
• Strong understanding of analytical method validation, stability programs, and CAPA implementation.
• Ability to manage IOQ activities related to analytical instrumentation placement and validation.
• Proven credibility as a leader with a "hands-on" management style.
• Strong negotiation skills to maximize value in client and regulatory discussions.
• Excellent oral and written communication skills, including experience engaging with clients during audits, tours, and meetings.
• Ability to recruit, mentor, and develop high-performing teams within budget constraints.
• High level of personal and professional integrity with the ability to work independently and collaboratively.