Senior Director, Quality

Position Summary

The Senior Director, Quality (SD) is responsible for all aspects of the quality organization including support and oversight for all internal and external GxP operations inclusive of clinical quality assurance (CQA). As the leader of the quality function, the SD establishes and maintains a culture of quality across the organization and is responsible for overseeing development, implementation, and continuous improvement of all quality systems to ensure that all products, processes, and operations comply with applicable regulatory requirements. The SD is ultimately responsible and accountable for critical decisions that directly impact product integrity, patient safety, regulatory compliance, and business continuing. The SD works with both internal and external stakeholders to manage timelines, meet internal deliverables and develop a best-in-class quality organization. This position develops, leads, and coaches the teams responsible for quality systems, quality control, document control, quality assurance, clinical quality, and compliance.

The SD responsibilities include implementation and continuous improvement of policies, procedures and standards necessary to ensure compliance with applicable GxPs. Additional responsibilities include team building, career development, assisting with financial reviews, establishment of annual budgets and identification and rollout of yearly goals and objectives and longer-term strategic plans for the department.

Key Responsibilities

• Provide oversight of quality risks and report risks to senior stakeholders.
• Manage a global audit program to ensure vendor/supplier performance and compliance, including development and presentation of meaningful metrics and summaries.
• Oversee maintenance of quality management system that collects, stores, establishes control and provides governance for the use of GxP data.
• Ensure compliance with all regulatory requirements and industry standards, including FDA, EMA, and ICH guidelines.
• Provide strategic direction and guidance to the quality team, ensuring alignment with company objectives and goals.
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality processes and systems.
• Represent the company in interactions and maintain strong relationships with regulatory agencies, external partners, industry groups, and internal stakeholders.
• Partner with clinical operations, CROs, and other key clinical staff to ensure clinical trials are conducted per GCP guidelines.
• Monitor and assess quality metrics and KPIs to identify trends and areas for improvement.
• Collaborate with cross-functional teams to ensure quality considerations are integrated into all aspects of product development, manufacturing, distribution, and clinical study design/execution.
• Conduct regular audits and inspections to assess compliance and identify potential risks and areas for improvement.
• Foster a culture of quality and compliance throughout the organization through training, communication, and recognition programs.
• Stay current with industry trends and developments and make recommendations for incorporating new technologies and approaches to enhance quality operations.
• Lead and mentor a team of quality professionals, providing guidance, feedback, and development opportunities.
• Perform other responsibilities as may be required by business needs.

Required Qualifications & Experience

• B.S. degree in a scientific discipline, including pharmaceutical, biologics, or a related field.
• Minimum 12 years of related experience in the pharmaceutical or biotech Industry at FDA regulated manufacturing sites within quality operations.
• Minimum 5 years of leadership/management experience within quality with at least 3 years of direct supervisory experience of technical/quality professionals.
• Background in biologics or cellular therapy manufacturing.
• Experience in hosting regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers.
• Advanced knowledge of FDA/ICH regulations, GxP quality systems and operational excellence required for the manufacture of cellular therapeutic products.
• General working knowledge of GCP/CQA.
• Demonstrated ability to perform long-term project planning with meaningful timelines and budget forecasting.
• Ability to prioritize multiple tasks, work under timeline pressures, and drive tasks to completion.
• Effective verbal and written communication and solid time management and organizational skills.
• Proficiency with Microsoft Office suite software (Word, Excel, PowerPoint, etc.).

Other Requirements

• Legally authorized to work for any employer in the U.S.
• Position is on-site in San Diego, CA

The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.

Base Pay Range Anticipated: $225,000 - $260,000

Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.

Compensation and Benefits

Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.