Senior Quality Systems Specialist

Janux is seeking a highly motivated Senior Quality Systems Specialist to play a critical role in ensuring compliance with regulatory standards, by implementing and maintaining the integrity of our Quality Management System.This all-encompassing GxP position will focus on system administration, implementation, and maintenance of an EQMS/EDMS/LMS, as well as oversight of document control and training. Other activities will include but not be limited to change controls, quality events, deviations, CAPAs, QMR, risk management, and routine reporting on quality systems and business process performance.

The Senior Quality Systems Specialist will be responsible for assisting in the current development and management of our Quality System, ensuring compliance by all departments and personnel with all applicable Regulatory Authorities and Janux requirements.

• Work closely with Quality team members to ensure cross-functional implementation of QMS (Deviations, Investigations; CAPA; Product Complaints; Change Control) ensuring compliance with applicable regulatory requirements.
• Assist in the development and execution of validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for Computer System Validation.
• Provide user assistance and training on document control, quality, and training management systems, processes, and procedures.
• System Administration and management of all document control and training management activities.  
• Generate and review quality reports, metrics, and key performance indicators (KPIs) to support GxP activities and Management Review.
• Evaluate, author, and/or review operating procedures (e.g. Policies, SOPs, etc.) to support an integrated cross-functional QMS.
• Support the implementation and maintenance of Janux EDMS/LMS/EQMS to ensure accuracy, accessibility, and regulatory compliance.
• Support migration activities into Janux EDMS/LMS/EQMS.
• Monitor and evaluate the effectiveness of training programs and make necessary adjustments to improve outcomes.
• Provide ongoing training and support to new hire and existing staff to ensure continuous compliance and improvement.
• Support and prepare for inspection readiness activities and participate in regulatory inspections and audits.
• Lead tactical records management operations on behalf of the Quality department, ensuring compliance and retention as applicable with regulatory requirements
• Other duties as required

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum of 4 years of experience in a quality systems role within the biotech or pharmaceutical industry.
• Strong proficiency in implementing, maintaining and utilizing quality management software and tools.
• Experience with Veeva Systems, MasterControl, Trackwise or Intellect highly preferred.
• In-depth knowledge of EQMS/LMS/EDMS, validation of computerized systems, and regulatory requirements.
• The ability to work with cross functional teams to ensure implementation of workflows meets the needs of individual departments.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency in system admin role for EDMS/LMS/LMS
• Experience with internal and external auditing programs in the pharmaceutical or biotechnology industry is a plus

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 X%

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.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.