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# Site Quality Head – San Diego-Orange County, CA


JRG Partners, a premier executive search firm, is thrilled to partner with a leading innovator in the manufacturing sector to find an exceptional Site Quality Head. This critical leadership role will oversee all quality operations across our client’s dynamic sites within the vibrant San Diego and Orange County, CA regions. If you are a visionary quality leader with a proven track record in establishing and maintaining world-class quality management systems, driving continuous improvement, and ensuring stringent regulatory compliance, we invite you to explore this unparalleled opportunity.
Our client is renowned for its commitment to excellence, groundbreaking products, and a culture that fosters innovation and professional growth. As the Site Quality Head, you will be instrumental in upholding this reputation, ensuring that all products meet the highest standards of quality, safety, and reliability. This role offers the chance to make a significant impact, shaping the future of quality for a company that truly values its people and its products.
Role Overview for Site Quality Head – San Diego – Orange County, CA
The Site Quality Head will be a pivotal member of the senior leadership team, directly responsible for the strategic direction, implementation, and oversight of all quality assurance and quality control activities across designated operational sites in San Diego and Orange County, California. This role requires a seasoned professional who can champion a culture of quality, drive operational excellence, and ensure robust compliance with national and international regulatory standards.
Reporting directly to a senior executive, the Site Quality Head will lead a diverse team of quality professionals, fostering their development and empowering them to achieve peak performance. You will be the ultimate authority on quality matters for your sites, influencing cross-functional teams, from R&D and engineering to manufacturing and supply chain, to embed quality at every stage of the product lifecycle. This position demands a strategic thinker capable of translating complex regulatory requirements into actionable quality processes and continuously seeking opportunities for improvement.
The successful candidate will be a proactive problem-solver, adept at risk management, and possess an unwavering commitment to product integrity and customer satisfaction. You will be instrumental in preparing for and successfully navigating internal and external audits, ensuring the sites are always inspection-ready. This is more than a managerial role; it’s a leadership position that will define and elevate the standard of quality for a forward-thinking organization at the forefront of its industry.
Key Responsibilities of Site Quality Head – San Diego – Orange County, CA
Strategic Quality Leadership
Develop, implement, and maintain a comprehensive site-specific Quality Management System (QMS) that aligns with corporate objectives and global regulatory requirements (e.g., ISO 9001, FDA regulations, cGMP). Continuously assess and enhance the QMS for effectiveness and efficiency.
Regulatory Compliance & Audits
Ensure all site operations comply with relevant national and international regulations, standards, and guidelines (e.g., FDA 21 CFR Parts 210, 211, 820; ISO 13485). Lead and manage all internal and external audits (FDA, Notified Bodies, customer audits), ensuring successful outcomes and timely remediation of any findings.
Team Leadership & Development
Recruit, mentor, and develop a high-performing quality assurance and quality control team. Foster a culture of accountability, continuous learning, and professional growth within the quality department. Provide clear direction, support, and performance feedback.
Process Improvement & CAPA
Drive continuous improvement initiatives across all manufacturing and support processes. Oversee the CAPA (Corrective and Preventive Action) system, ensuring thorough investigations, effective root cause analysis, and timely implementation and verification of corrective actions.
Risk Management
Implement robust risk assessment and management strategies to identify, evaluate, and mitigate quality risks throughout the product lifecycle, from design to post-market surveillance.
Supplier Quality Management
Establish and maintain effective supplier quality programs, including supplier qualification, performance monitoring, and audits, to ensure the quality of incoming materials and components.
Documentation & Data Integrity
Ensure all quality documentation is accurate, complete, and maintained in accordance with regulatory requirements and internal procedures. Oversee data integrity practices for all quality-related data.
Product Release & Disposition
Oversee the final review and release of products, ensuring all quality checks and specifications are met before distribution. Manage non-conforming materials and product disposition processes.
Cross-Functional Collaboration
Collaborate effectively with R&D, Engineering, Manufacturing, Supply Chain, and other departments to integrate quality principles into all operational aspects and support new product introductions.
Budget Management
Manage the quality department budget, ensuring resources are allocated effectively to achieve quality objectives.
Training & Awareness
Develop and deliver comprehensive quality training programs for all site personnel to enhance quality awareness and ensure adherence to QMS procedures.
Requirements for the Site Quality Head – San Diego – Orange County, CA
Education
Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related technical field is required. A Master’s degree or MBA is highly preferred.
Experience
Minimum of 12-15 years of progressive experience in Quality Assurance/Quality Control roles within a highly regulated manufacturing environment (e.g., medical device, pharmaceutical, biotechnology, aerospace). At least 7-10 years must be in a senior leadership or management capacity, overseeing a significant quality function.
Regulatory Expertise
In-depth knowledge and hands-on experience with FDA regulations (e.g., 21 CFR Part 820 QSR, 21 CFR Part 210/211 cGMP), ISO standards (e.g., ISO 9001, ISO 13485), and other relevant international quality standards. Proven track record of successfully managing FDA inspections and Notified Body audits.
QMS Implementation
Extensive experience in designing, implementing, maintaining, and improving robust Quality Management Systems.
Leadership Skills
Demonstrated ability to lead, motivate, and develop large teams of quality professionals. Exceptional interpersonal, communication, and presentation skills.
Technical Acumen
Strong understanding of manufacturing processes, statistical process control (SPC), risk management tools (FMEA), and problem-solving methodologies (8D, A3).
Certifications
ASQ certifications (e.g., Certified Quality Manager, Certified Quality Engineer, Certified Quality Auditor) are highly desirable. Lean Six Sigma Green or Black Belt certification is a significant advantage.
Problem-Solving
Proven ability to analyze complex issues, identify root causes, and implement effective corrective and preventive actions.
Communication
Excellent written and verbal communication skills, with the ability to articulate complex quality concepts to diverse audiences, including senior leadership, regulatory bodies, and shop floor personnel.
Location
Ability to work on-site across facilities within the San Diego and Orange County, CA regions.
Benefits & Perks Offered
Our client offers a comprehensive and competitive benefits package designed to attract and retain top talent. This includes:
Competitive Compensation
A highly attractive base salary commensurate with experience and a performance-based bonus structure.
Health & Wellness
Robust medical, dental, and vision insurance plans for employees and their families, often with low deductibles and comprehensive coverage.
Retirement Planning
A generous 401(k) retirement plan with company matching contributions, helping you secure your financial future.
Paid Time Off
Ample vacation, sick leave, and paid holidays to support work-life balance and personal well-being.
Professional Development
Opportunities for continuous learning, training, and career advancement, including tuition reimbursement and access to industry conferences.
Life & Disability Insurance
Company-paid life insurance and short-term/long-term disability coverage.
Employee Assistance Programs
Resources to support mental health, financial planning, and personal challenges.
Relocation Assistance
For qualified candidates, relocation support may be provided.
Dynamic Work Environment
A collaborative, innovative, and inclusive culture where your contributions are valued and recognized.
How to Apply
If you are a driven and experienced Quality leader ready to take on a challenging and rewarding role with a leading organization, we encourage you to apply.
Please submit your resume and a cover letter detailing your qualifications and experience relevant to this position through the JRG Partners career portal. For more information on how JRG Partners excels in executive placements, visit our Manufacturing & Operations Recruitment page.
JRG Partners is committed to connecting top talent with exceptional opportunities. We look forward to reviewing your application and discussing how your expertise can contribute to our client’s continued success.