Cellular Therapy ManufacturingClinical Quality AssuranceGxP ComplianceQuality AssuranceQuality Control
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Original posting
About Tr1X
Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio.
Position Summary
The Senior Director, Quality (SD) reports to the Chief Technical Officer and 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.
Working at Tr1X
At Tr1X, our team is united by a singular shared mission: to transform patients’ lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.
Base Pay Range Anticipated: $240,000 – $270,000
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.
Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at careers@tr1x.bio.
Notice to Employment Agencies
The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.