Director Of Quality Assurance

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Job description

Company Overview

Janux Therapeutics is a biotechnology company based in San Diego that is leveraging an innovative and proprietary discovery platform to efficiently develop tumor activated drugs that empower the immune system to eradicate cancer. Janux is developing unique immunotherapies that generate tumor-specific immune responses to attack and kill tumors without destroying a patient's healthy tissue. As an early-stage startup company, Janux is looking for energetic and talented candidates with a desire to work in a fast-paced and dynamic team environment. We believe that the whole team contributes to the overall mission. We succeed as a team, and we grow as a team.

Job Position Overview

Janux, Inc. is seeking a Director of Quality Assurance. This position is responsible for establishing and maintaining global standards for GXP compliance meeting all compliance requirements pertaining to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), ICH, FDA and EMA regulations. The qualified candidate will have experience in building and maintaining sustained and trusting relationships with key strategic internal and external stakeholders, including the ability to grow the Quality function to support development programs from preclinical to commercial phases. The Director of Quality will be accountable for the performance of the Quality Management System including training, compliance, audit planning and management, process improvement, product release, relationships with partners and suppliers, and effective communications related to quality initiatives. The person who joins our team in this role will collaborate with Pre-Clinical, CMC and Clinical Operations to establish and move forward GXP initiatives. This person will lead and support process improvement projects and ensure quality, and compliance processes and metrics are met.

Responsibilities

• Ensure that a robust Quality System is effectively established, implemented and maintained in accordance with applicable standards.
• Create and promote Quality awareness within the organization.
• Provides effective execution of the Quality Strategy and Risk Management activities
• Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance with regulations and internal procedures.
• Leads the trending and metrics programs for Quality Systems; assess each functional area for continuous improvement.
• Ensures a robust CAPA program is in place with timely processes for root cause analysis, verification of actions and effectiveness assessments.
• Facilitates and supports inspections by regulatory authorities and maintains a state of inspection readiness, including the leading of mock inspections. Participates in the development of responses to agency observations and ensures CAPAs are completed timely with appropriate effectiveness verification.
• Investigates and collaborates with other departments to resolve quality matters.
• Will be an agent of positive change, innovation and continuous quality improvement, with the ability to influence across functions.
• Drive to ensure that products under development are compliant with FDA and other regulatory requirements.
• Drive GXP compliance guidance to cross-functional teams.
• Manage the review and approval of finished products manufactured for the company are in accordance with their approved specifications.
• Review records and data for product release.
• Manage product recall activities to include policies and procedures for the company.
• Additionally, manage product complaint activities and processes.
• Establish and update quality agreements with CMOs and contract laboratories.
• Lead internal and external audits for the organization.
• Drive audit programs with an appropriate risk assessment and mitigation approach for CROs, CMOs, clinical sites, depots, etc. and internal departments.
• Ensure inspection readiness at CMOs and CROs.
• History of recruiting and building a team with the ability to mentor and develop a start-up organization.
• Achieve financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
• Maintain knowledge of existing and emerging industry related regulations, standards, or guidance requirements.
• Supervises electronic document control systems.
• Work with operations 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.
• Serves as Management Representative on all Quality functions.
• May perform additional duties as assigned or directed by management.

Qualifications & Skills

• High level of personal and professional integrity with strong work ethic and the ability to work independently with minimal direction.
• 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 remediation's for regulatory findings.
• Computer knowledge and skills.
• Ability to travel (estimated at 5%-10% of time).

Education & Experience

• Bachelor's degree in life science or related field or the equivalent combination of education and/or experience.
• Seven to ten years of relevant quality experience in the pharmaceutical or biotech fields
• Experience interacting with the FDA
• Previous experience managing teams or people.
• Working knowledge of quality system requirements.
• Previous oncology and biologics experience preferred.

Compensation

In addition to a competitive compensation package with stock options and stock purchase plan, Janux also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance is also available.

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 %

Work Location:

● On site required - La Jolla / Torrey Pines

● Working remotely available

Company's website:

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Janux requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Janux will consider requests for Reasonable Accommodations.

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.