Senior Manager, Quality Systems

 

 

About Tr1X

Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit www.tr1x.bio.

Position Summary

The Senior Manager, Quality Systems provides support to the Executive Director, Quality and contributes to the successful achievement of Tr1X’s product development objectives through monitoring compliance with all applicable regulations (local, State, FDA, and other applicable agencies). The QMS Senior Manager is responsible for all aspects of the Tr1X Quality System and provides oversight for implementation and validation of an electronic Quality Management System (eQMS) with migration from a paper-based system. The Senior Manager works with both internal and external stakeholders to meet timelines and internal deliverables.

Key Responsibilities

• Oversee all aspects of the Tr1X Quality System, including training, document control, change control, and quality event management.
• Develop documentation and SOPs to implement and improve Tr1X Quality systems; identify opportunities to streamline and improve QMS processes.
• Manage compliance with applicable regulations and procedures, including training completion and on time closure of quality events/records.
• Implement and validate the eQMS; transition paper-based system and document updated procedures and SOPs.
• Provide training to employees on system use and functionalities and onboard new users as required.
• Ensure adherence to applicable regulations, including FDA, ISO, ICH, and company policies and procedures and ensuring records are up to date.
• Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Support all Quality department needs as may be identified based on business needs.

Required Qualifications & Experience

• Bachelor’s degree in a scientific discipline or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
• Minimum 7 years of related experience with a minimum 3 years of experience with Quality System management duties in the pharmaceutical, or biotech industry
• Prior experience in eQMS system administration
• Experience and knowledge in establishment and management of quality systems, including validation of eQMS to 21 CFR Part 11 Compliance
• Working knowledge of FDA, ICH, ISO, and GAMP regulatory guidance and regulations
• Superior organizational, communication, and detail-orientation skills
• Highly proficient in MS Office 365 (with an emphasis on MS Word)
• Experience with cell therapy products desirable
• ASQ certification preferred
• Working knowledge of Quality Operations and CTD/eCTD standards

Other Requirements

• Legally authorized to work for any employer in the U.S.
• Position is eligible for a hybrid working arrangement with a minimum three days per week on-site in San Diego, CA

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: $137,000 - $155,000

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.