Quality Director

Quality Director/Head of Quality

As the site's Leadership Team member, the QA Director will lead and direct the daily activities of Quality Assurance supporting the Company's analytical operations. Develop, implement, maintain and improve upon the cGMP compliant systems in alignment with the company and corporate quality strategies and objectives.

Contract:

• Start Date: ASAP
• Location: Irvine, CA
• Hours: 40 hours a week
• Length: up to 12 months

Responsibilities:

This list of responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.

1. Leadership & Quality Systems

• Direct staff to ensure timely and right-first-time execution of Quality Assurance activities supporting analytical operations.
• Provide cGMP compliance expertise and leadership.
• Lead site Quality Management Review activities and escalate quality and compliance risks as appropriate.
• Ensure quality decisions are based on scientifically sound and risk-based principles consistent with ICH Q9.

1. Quality System Oversight

• Provide oversight of Data Integrity, computerized systems, and electronic records compliance.
• Provide oversight of change controls, investigations/CAPA of OOS/OOT/deviations, ensuring compliance and risk-based decision making consistent with ICH Q9.
• Conduct customer complaint investigations as needed.

1. Technical & Operational Oversight

• Provide quality oversight for analytical method qualification, validation, verification and transfer activities.
• Coordinate GMP and quality training programs.
• Monitor quality metrics and drive continuous improvement.

1. External Interface

• Lead regulatory inspection readiness and serve as primary quality representative during inspections.
• Serve as primary quality representative for clients.
• Provide quality oversight of suppliers, contractors and service providers.

1. People & Culture

• Lead, develop and manage Quality Assurance personnel through effective hiring, coaching, performance management, succession planning and employee development.
• Promote a culture of safety and ensure compliance with site safety, environmental, and 5S workplace organization requirements.

Core Competencies:

• Accountability - Making a commitment to the organization and meeting obligations, adhering to policy, and accepting responsibility.

• Ethics & Integrity - Exhibiting personal integrity and professionalism, aligning with organizational values, and modeling ethical behavior.
• Interpersonal Competencies - Contributing to the team, communicating effectively, working cooperatively, resolving conflict, building team capability, and celebrating success.
• Strategic Competencies - Identifying what needs to be done, taking action, adding value and participating in positive change.

Qualifications - Experience and Education:

• Minimum 15 years of pharmaceutical, biotechnology, CDMO, or contract testing laboratory experience, including at least 5 years in quality leadership roles with direct management responsibility.
• Bachelor's degree or equivalent in scientific discipline required. Advanced degree preferred. ASQ certification preferred.
• Demonstrated experience hosting and leading successful regulatory inspections and client audits.
• Demonstrated experience implementing and maintaining Data Integrity programs within GMP regulated laboratories.

Knowledge, Skills, and Abilities:

• Advanced knowledge of cGMP, FDA regulations, and ICH guidelines as they pertain to contract laboratory operations.
• Advanced knowledge of USP, Pharm. Eur. and other compendial methods and procedures.
• Advanced knowledge of wet chemistry, chromatography, spectrometry, calorimetry and microbiology testing equipment and methodology.
• Advanced knowledge of root cause investigation and problem solving; experience in the use of 5 Whys and/or other appropriate root cause investigation tools.
• Advanced knowledge of laboratory computerized systems including LIMS, CDS, electronic document management systems, and related regulatory requirements for electronic records and signatures.
• Strong interpersonal skills. Must be able to express oral and written communication in a clear and concise manner and effectively present information and respond to questions from managers, customers and employees.
• Strong project management skills with demonstrated ability to take programs from concept to execution and manage all stages.
• Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed.
• Demonstrated problem-solving /decision-making skills with the ability to prepare contingency plans and future strategies proactively.
• Ability to work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors, exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to manage effectively, setting clear expectations, establishing accountability, monitoring progress and outcomes.
• Ability to work effectively and diplomatically in resolving conflicts.