Manager/Sr. Manager, Quality Systems

VENTYX BIOSCIENCES, INC.-posted 10 months ago
$150,000 - $190,000/Yr
Full-time • Mid Level
San Diego, CA
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Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. The Opportunity: Manager/Sr. Manager, Quality Systems: We are seeking a highly motivated individual to serve as the Manager/Sr. Manager, Quality Systems at Ventyx. This individual will report to the Sr. Director, QMS and Data Integrity and will play an essential role in developing and maintaining quality systems that support and ensure GxP compliance, including Change Control, CAPA, Deviation and Quality Management Review.

  • Co-lead the development of a long-term compliance strategy for Quality System design, growth, and process improvement efforts in support of the drug development phase.
  • Support the implementation of the electronic Quality Management System for Change Control, Deviation, and CAPA quality systems.
  • Assess and lead the continuous improvement efforts of the Change Control, Deviation, and CAPA processes and procedures.
  • Manage and track Deviations, Change Controls, and CAPAs to ensure timely completion.
  • Train and mentor users on the Change Control, Deviation, and CAPA process and procedures.
  • Prepare and manage Quality Management Reviews including generation of metrics.
  • Generate Quality System metrics as per established timelines to monitor compliance.
  • Interact with Quality Assurance and cross-functional stakeholders on the performance of quality systems (e.g. Change Control, Deviation, and CAPA).
  • Lead and coordinate the Change Review Board (CRB) meetings.
  • Manage direct reports as necessary to support the Quality Systems function.
  • Crosstrain and support the Document Control and Training functions on execution of daily tasks as required.
  • Other responsibilities as assigned.
  • Bachelor’s degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
  • 7+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.
  • Experience implementing and managing key quality systems such as Change Control, CAPA and Deviation.
  • Experience with 21 CFR part 11 compliant document management systems (e.g. Veeva or similar systems).
  • Experience with validation of eQMS including system updates and maintenance.
  • Appreciation of quality risk management concepts.
  • Working knowledge of US FDA and EU regulatory requirements for biologics or pharmaceuticals including US FDA CFR Parts 210 and 211, ICH Q7 and Q10, EU Directive 2001/20/EC.
  • Strong negotiation and influencing skills with internal and external stakeholders.
  • Excellent verbal and written communication, strong organizational and interpersonal skills.
  • Ability to work both independently and collaboratively in a fast-paced matrixed environment.
  • Competitive compensation and a comprehensive benefit package, including stock options.
  • Medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.
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