Clinical Quality Associate Director

Position Description

The Clinical Quality Associate Director will provide support to the Sr. Director of Quality and contribute to the successful achievement of Tr1X’s clinical program objectives through monitoring compliance with all applicable regulations (local, State, FDA, and other applicable agencies). The Clinical Quality Associate Director will be responsible all aspects of Clinical Quality, oversee external Contract Research Organizations (CROs), and provide additional support for the Tr1X internal quality systems. This candidate will also lead GCP compliance strategies and be an integral part of all clinical program teams.

The successful candidate will work with both internal and external stakeholders to meet timelines and internal deliverables.  

Key Duties and Responsibilities

• Oversee – all aspects of Clinical Quality for internal processes as well as those of CROs, vendors, and investigator sites.
• Assist - in the development of documentation and implementation of systems and SOPs.
• Review – internal and external records for compliance with applicable regulations and procedures.
• Follow - applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
• Support – all Quality department needs as identified by management.
• Keep - abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
  
  

The Team – Yes You Belong!

We are building a diverse, bold, agile, and collaborative organization where each team member works closely and communicates respectfully with each other. Tr1X leadership has high expectations for themselves and for you (and so should you!): we expect the company and all its employees to be deeply focused on bringing Tr1X’s therapies to patients at an accelerated pace.

Key attributes to this role include a “can do” attitude, enthusiasm for science, integrity, attention to details, problem solving, collaborative spirit.

You have:

• Bachelor’s or Master’s degree in scientific discipline
• A minimum of 8 (MS/MA) or 10 (BS/BA) years of related experience with a minimum of five (5) years of experience in Clinical Quality Management in the pharmaceutical, or biotech industry
• Experience and knowledge in establishment and management of quality systems, vendor and investigator site audits, and CRO oversight.
• Working knowledge of FDA and ICH regulatory guidance and regulations
• Equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable
• Superior organization skills.
• Highly proficient in MS Office 365 (with an emphasis on MS Word)

Optimally you also have

• Experience with cell therapy products and clinical trials
• Working knowledge of Clinical Quality Operations and CTD/eCTD standards
• Participated in regulatory inspections
• ASQ CQA certification

You are

• Legally entitled to work for any employer in the US.

We offer

In addition to a competitive compensation package with stock options, Tr1X offers comprehensive benefits for our employees and their families. This includes:

• Medical, dental and vision insurance
• 401k with employer match
• PTO
• Long Term Disability (LTD)
• Company paid holidays, including the year-end holiday break