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A clinical-stage manufacturing organization is seeking a Site Quality Head to lead all Quality Assurance, Quality Control, Quality Systems, and Compliance activities at its Camarillo, California facility. Reporting to senior quality leadership, this individual will be responsible for establishing and maintaining a site quality system that meets FDA regulations, cGMP requirements, and global quality standards. The Site Quality Head will provide oversight across manufacturing operations from material dispensing through final product release, ensuring quality decisions are made with sound technical judgment while maintaining inspection readiness and regulatory compliance. This role serves as the senior quality leader for the site and works closely with regulatory, operations, corporate leadership, external regulators, and customers. The Camarillo site operates in a dynamic, clinical-stage environment supporting complex sterile drug product programs, offering the Site Quality Head the opportunity to directly influence site strategy, quality culture, and the advancement of client programs.
The successful candidate will direct quality strategy, quality systems implementation, compliance programs, internal audits, regulatory gap assessments, and continuous improvement initiatives. Responsibilities include managing Manufacturing Quality Assurance, Quality Control, and Quality Systems functions; leading quality oversight for new products, process changes, and operational improvements; ensuring compliance with contamination control and sterility assurance requirements; driving accountability for product and process quality decisions; and providing technical guidance for investigations, deviations, and quality-related escalations. The Site Quality Head will also oversee chemistry and microbiology laboratory operations, environmental monitoring programs, stability testing activities, and site quality metrics while ensuring consistency with global quality standards and procedures.
This position requires a visible and highly hands-on leader capable of developing high-performing quality teams, strengthening technical capabilities, driving effective execution across QA and QC functions, and building strong customer relationships through responsive communication, effective deviation management, and consistent quality performance. The individual will serve as the primary quality representative to customers, leading audit responses, technical communications, and sponsor-facing quality activities. Additional responsibilities include hiring, developing, and retaining talent, managing the site quality budget, providing site leadership with data to support regulatory compliance and operational performance, and fostering a culture of accountability, collaboration, and continuous improvement.
Candidates must possess a bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, or another related scientific discipline, and a minimum of 15 years of progressive quality operations experience in a regulated environment, including project, technical, and personnel management responsibilities. At least five years of leadership experience managing cross-functional quality teams is required. The ideal candidate will have demonstrated expertise across Quality Assurance, Quality Compliance, Quality Control, Quality Systems, and Continuous Improvement within a CDMO or similarly fast-paced, client-facing manufacturing environment, including direct responsibility for sponsor-facing quality oversight and client relationship management. Direct experience in aseptic drug product manufacturing, including lyophilized and liquid fill-finish processes, is essential, along with strong GMP laboratory leadership experience supporting analytical and microbiology functions. Candidates should possess excellent communication skills, proven experience leading investigations and technical problem-solving efforts, and the ability to make timely, compliance-focused decisions in a fast-paced clinical manufacturing environment.
The anticipated base salary range for this position is $186,000 - $230,000 annually. Actual compensation will be determined based on several factors, including the candidate's qualifications, relevant experience, technical expertise, leadership background, and demonstrated success in quality operations, GMP compliance, and pharmaceutical manufacturing environments. In addition to base salary, the selected candidate may be eligible for incentive compensation and a comprehensive benefits package. This salary range represents the good faith estimate expected at the time of posting.