Associate Director, Quality Assurance

2 weeks ago

San Diego, United States Janux Therapeutics Full time

JOB SUMMARY

The Associate Director of QA, in conjunction with the Director, QA, will be responsible for the performance of the Quality Management System including training, compliance, audit planning and management, process improvement, and effective communications related to quality initiatives with the leadership team. The person who joins our team in this role will collaborate with CMC to implement GMP initiatives. This person will work with the project management lead for CMC and support process improvement projects and ensure quality, and compliance processes and metrics are met.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

  • Participate in the effective implementation of a robust Quality System and ensure its maintenance in accordance with applicable standards.
  • Create and promote Quality awareness within the organization. Drive appropriate internal compliance training and keeps program up to date.
  • Provides effective execution of the Quality Strategy and Risk Management activities
  • Author, review and approve SOPs, protocols, reports, Master Batch Records and Executed Batch Records and other CMC quality and regulated records for accuracy and compliance with regulations and internal procedures.
  • Responsible for product disposition Lead the investigation of quality events and collaborates with other internal or external departments to resolve quality matters and implement appropriate corrective and preventive action
  • Establish and update quality agreements with CMOs and contract laboratories.
  • Lead internal and external audits for the organization.
  • Develop audit programs with an appropriate risk assessment and mitigation approach for CDMOs, including inspection readiness.
  • Maintain knowledge of existing and emerging industry related regulations, standards, or guidance requirements.
  • Work with CMC leadership team on the implementation of process controls programs.
  • Participate in cross-functional teams (Regulatory Affairs, CMC, Pre-clinical, Clinical Operations, Quality, etc.) supporting the overall strategy, design, and execution of the Company's pipeline.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES
  • BS in life science or related field or the equivalent combination of education and/or experience.
  • 7-10 years of relevant quality experience in the pharmaceutical or biotech fields, plus 3+ years of QA experience within a CMC department, including experience setting up a quality system.
  • Requires previous oncology and biologics experience.
  • Ability to lead, influence, create and work within cross-functional team environments.
  • Experience/expertise with GMP, GLP, and GCP requirements.
  • Excellent communication and presentation skills.
  • Proven track record with successful audits, including implementing remediations for regulatory findings.
  • Working knowledge of quality system requirements.
  • Ability to travel (estimated at 5%-10% of time).
Compensation:

In addition to a competitive base salary ranging from 165,000 to 195,000, 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. Relocation assistance may also be available.

Please note that the hourly rate 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 15%
Work Location:
  • Onsite - San Diego


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.

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