At ACELYRIN, INC. the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency.  Our key value of courageous caring means putting patients first and having the courage needed to quickly solve challenging issues, we strive to redefine what is possible and quickly bring innovative therapies to bear against serious diseases.

 

Location:  Los Angeles

Job Title:  Vice President Quality Assurance

Reports To:  Chief Legal and Administrative Officer               

Function:  Quality          

Job Type:  Full-time       

 

Position Summary:

The Vice President, Quality Assurance is responsible for overseeing and directing the development, implementation and maintenance of quality management practices and systems as governed by GCP, GMP, GPV and GLP (GxP) regulations, to ensure compliance with internal policies, business objectives, procedures, and external regulations and standards.

 

Responsibilities:

  •  Provides strategic direction, develops and maintains the company’s Quality Assurance Management System (QMS).

  • Create a culture of quality that is patient-centric first and foremost.
  • Ensures quality and operational regulatory compliance; acts as a subject matter expert for quality investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs.
  • Designs and oversees the execution of GXP and SOP training programs; develops and maintains centralized system for GXP documents including record control, archival, protection and access.
  • Develops the Quality Assurance operating budget and monitors expenditures.
  • Develops and maintains positive working relationships with service provider organizations; establishes appropriate service provider qualifications and disqualifications.
  • Act as a trusted advisor and business partner in balancing risk and opportunity and advise on strategic decision-making.
  • Serve as the company subject matter expert and advisor on quality trends, guidance's and changes.
  • Provide training, and interpretation of regulatory guidelines or issues to personnel.
  • Participates in the selection and qualification process of clinical, nonclinical, and manufacturing vendors/contractors.
  • Participates in the selection, qualification and overseeing of services of local quality consultants in various geographic regions where GXP contracted activities are needed.
  • Oversees clinical/pre-clinical program quality audit planning, execution and resolution of issues.
  • Supports regulatory inspections.
  • Handles product complaints, changes and deviations; leads / supports investigations to resolve quality issues.
  • Identifies GXP and other key compliance requirements and provides leadership in promoting awareness and understanding of global regulatory compliance expectations.
  • Ensures harmony across SOPs and shared responsibilities.
  • Leads the Audit Program management process, including assessment of internal and external (outsourced) GXP operations.
  • Works with cross functional and other internal project teams to effectively support process and quality enhancement initiatives.
  • Provides leadership in the development of change strategies that align resources and encourage a collaborative, supportive and high performing work environment.
  • Partners with senior management to ensure that best practices and proper training are adopted including compliance with all quality policies, quality improvement initiatives and ensuring appropriate quality systems are implemented and maintained.
  • Develop, implement, maintain, and communicate the Company's quality strategy and programs.

 

Qualifications and Skills Required:

  • Minimum of 10 years of experience in the pharmaceutical R&D industry, of which a minimum 8 years should be hands-on Quality Assurance experience.
  • Excellent verbal and written communicator who can tailor communication style for a diverse set of internal and external stakeholder.
  • Start-up experience preferred

 

Essential behaviors and ways of working:

  • Sets and supports organizational tone in line with ACELYRIN culture
  • Entrepreneurial mindset and behaviors
  • High energy, but respectful and encouraging with internal and external peers and staff
  • Leadership, respect, encouragement, and motivation in virtual and face-to-face engagements
  • Effective in-person and remote-work capability
  • Collaborative, cross-functional team leader and member while also being an independent, hands-on contributor
  • Ability to work effectively with all levels of ACELYRIN, our partners, and external collaborators

 

ACELYRIN, INC, does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.  Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

 

 

This position has been filled. Would you like to see our other open positions?