Manager/Sr. Manager, Quality Systems

Description

Description

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.

What You Will Contribute

• Co-lead the development of a long-term compliance strategy for Quality System design, growth, and process improve 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 task as required.
• Other responsibilities as assigned.
  
  

What We Seek

• 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. Stays current with industry trends, regulatory changes, and best practices in QMS to proactively apply knowledge to managing processes and systems.
• 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.
  
  

What We Provide To You

• The opportunity to make a difference in people’s lives impacted by autoimmune and inflammatory diseases.
• Participate in a team of life science professionals who value science, data, high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
• Competitive compensation and a comprehensive benefit package, including stock options.
  
  

The anticipated annual base salary range for this role is $150,000 - $190,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, company needs, and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, LTD, time off, a retirement plan, and other voluntary benefits for employees.

Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race, age, ethnicity or national origin, color, religion, sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, sexual orientation, disability or medical condition (including genetic information or characteristics or those of a family member), military service or veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Notice To Recruiters And Agencies

The Human Resources team manages the recruitment and employment process for Ventyx Biosciences. To protect the interest of all parties involved, Ventyx Biosciences does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing or recruiting agencies or fee-based referral services. The submission of referrals or resumes by anyone other than a candidate directly to Ventyx Biosciences’ employees is strictly prohibited. Unsolicited referrals and resumes sent to Ventyx are deemed gratuitous, and do not obligate Ventyx to pay fees should we hire from those resumes. Recruiters are requested NOT to contact or present candidates directly to our hiring managers or employees. Please direct all inquiries to careers@ventyxbio.com.