Associate Director, Clinical Quality Assurance

Associate Director, Clinical Quality Assurance

The Clinical QA Associate Director will oversee the quality assurance activities related to clinical trials and ensure compliance with regulatory requirements, company policies, and industry standards.  This role also provides strategic planning for continuous improvement efforts, reporting/escalation of critical quality issues, conducting risk mitigation for clinical trial activities, and ensuring a compliant culture of quality while collaborating with cross-functional teams to maintain the highest standards of quality in clinical research.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

These may include, but are not limited to:

• Support Clinical Quality Assurance initiatives (including TMF and Site audits)

• Partner with clinical functions to ensure that clinical trial activities are conducted in compliance with GCP regulations and internal requirements.

• Lead efforts to evaluate and contribute to clinical program design and execution (e.g., protocols, ICFs, CAPAs, CSRs

• Provide QA oversight of clinical trial partners [e.g. contracted Clinical Research Organizations (CROs), contractors]; identification and onboarding of new third-party partners as necessary

• Support the Qualification and monitoring of GXP suppliers ensuring relevant findings are escalated to Quality Management and stakeholders.

• Review Clinical Agreements defining responsibilities and communication processes for quality related activities.

• Execute internal and external audits including any finding from investigations, root cause analysis, corrective/preventive action implementation, and effectiveness checks.

• Develop strategic plans using a Quality Systems approach to accommodate department and Quality growth and lead the clinical operations team toward successful implementation and execution of GCP systems and procedures.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• BS/MS degree in science with 8+ years of pharmaceutical work experience or equivalent.
• Applied knowledge of Quality/Compliance and GCP, GLP, and/or GMP requirements.
• Broad knowledge/experience in Clinical QA.
• Self-motivated with ability to work independently and operate effectively within a collaborative work environment.
• Detail oriented with strong organizational and communication skills.
• Experience interacting with FDA, EMA, and other global health authorities
• Position Requires 10-20% travel.
• Experience with building a GCxP culture in a start-up company preferred

Compensation:

In addition to a competitive base salary ranging from $170,000 - $190,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity and work location.

Job Type: Full-time

Benefits:

• 401K
• Medical insurance
• Dental insurance
• Vision insurance
• Supplemental disability insurance plans
• Flexible schedule
• Life insurance
• Flexible vacation
• Sick time
• Incentive stock option plan
• Relocation assistance

Schedule:

• Monday to Friday

Work authorization:

• United States (Required)

Additional Compensation:

• Annual targeted bonus 20%

Work Location:

• On site (San Diego, CA)

EQUAL OPPORTUNITY EMPLOYER:

Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.