Quality Control Director

Argonaut Manufacturing Services•Carlsbad, CA

13d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.