Director of Total Quality Deployment jobs in Santa Cruz, CA

Our client in California has an opening for a Director of Quality.

This is a hybrid position with occasional travel required
Salary based on experience: $170K - $190K

Job Summary:

The Director of Quality is responsible for overseeing operations to ensure compliance with applicable regulations while increasing the quality of our client's products. Duties and responsibilities include managing quality leadership, formulating and driving execution of high-level quality strategies, overseeing operations in the quality department across multiple sites, leading quality process development, managing the quality of our internal suppliers and external vendors, closely collaborating with cross-functional partners, and design and integration of the quality organization across sites to build synergies and efficiency throughout the business.

To support a collaborative working environment and strengthen our company's culture, there is a need for this role to have regular in-office presence either at our Watsonville, CA, or Vista, CA location for 2-3 days per week. Additionally, the role involves occasional travel, approximately 15-30% of the time, to various company sites to facilitate seamless communication and project coordination.

Key Responsibilities:

• Manages QA leadership across all facilities spanning 3 physical locations.

• Guide the development, interpretation, and enforcement of quality systems, programs, and processes as per corporate policy and GMP regulations under 21 CFR Part 111 and 21 CFR Part 101.

• Report on performance at manufacturing sites for overall site metrics, and key issues to be presented to management.

• Oversee activities directly related to product quality and provide direction to the team for complex product dispositions and decisions as necessary.

• Ensure audits of the existing company Quality Systems and procedures are executed and ensure all findings are addressed appropriately per cGMP regulations and for continued improvement to the company Quality System.

• Ensure QA personnel are adequately trained to fulfill quality systems duties as per 21 CFR Part 111 GMP requirements.

• Work proactively to ensure our product's quality and performance are best in class.

• Review and make necessary continuous improvements to the current non-conformance, CAPA, and deviation processes.

• Oversee management of Customer Quality Complaints and adverse events. Escalate and report high incidents to the Operations Manager to determine if further actions are required to ensure products that do not meet quality standards are either prevented from distribution or recalled.

• Determine staffing requirements, and interview, hire, and train new employees, or oversee those personnel processes.

• Coach and mentor quality leadership, creating opportunities for growth and development.

• Interfaces with manufacturing partners to address and resolve more complex product/process/system performance issues.

• Works closely with R&D leadership to ensure new product development processes are conducive to high-quality product post-launch.

• Partners with Regulatory leadership to ensure regulatory requirements are met.

• May interface with regulatory agencies as required.

• Collaborates with marketing to establish processes that ensure the voice of the customer is considered when establishing non-regulatory mandated specifications.

• Establish and implement departmental policies, goals, objectives, and procedures, conferring with managers and staff members as necessary.

• Align manufacturing sites with continuous improvement programs.

• Other duties as assigned.

Key Contributions in the First Year:

• Re-design and integrate of the quality organization across sites to build synergies and efficiency.

• Review existing quality infrastructure, software, and processes to identify and close current gaps.

• Establishment of a stability team and robust process to monitor and improve product stability on an ongoing basis.

Position Qualifications:

Experience & Education Requirements:

• BA/BS in the life sciences (biology, biochemistry, etc), engineering, or related fields of education. An advanced degree is a plus.

• 9 years of experience in a related field within the food or dietary supplement industry. Dietary supplement experience preferred.

• 4 years of managerial experience. Strong management capabilities are a must.

Specific Required Skills:

• Strong experience in leading and managing personnel.

• Strong experience in leading and managing regulatory inspections.

• Strong experience with leading and managing quality investigations.

• Strong working knowledge of cGMPs (US, Canada, and International)

• Experience in writing and reviewing Quality Agreements.

• Strong internal and external auditing experience. Certified Quality Auditor would be a plus.

• Strong leadership and negotiation skills.

• Must have excellent verbal, written, and interpersonal communication skills.

• Dietary Supplement Experience is a must

Knowledge, Experience & Preferred Skills:

• Demonstrates in-depth knowledge of GMPs.

• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.

• Demonstrates excellent verbal, written, and interpersonal communication skills.

• Demonstrates knowledge of Information Systems Technology, and understanding of Computer System Validation (CSV) including current electronic records and signature requirements.

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures, and quality improvement statistics is a plus.

• Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA)) is a plus.

• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is a plus.

Computer Skills:

• Must be proficient with MS Office and have advanced Excel skills.

• Proficiency with SAP HANA is preferred.

Applicants must be authorized to work in the U.S.

We are an equal-opportunity employer. We do not discriminate in hiring or employment against any individual on the basis of race, color, gender, national origin, ancestry, religion, physical or mental disability, age, veteran status, sexual orientation, gender identity or expression, marital status, pregnancy, citizenship, or any other factor protected by anti-discrimination laws.