Vice President, Quality Assurance

San Diego, California | Full-Time

Job viewed13562times

S/he will design, implement and maintain QA and compliance programs and infrastructure - including an SOP system and training program - and perform internal and external audits. The VP QA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. They will also serve as an in-house advisor on GxP compliance.

 

What you’ll dive into:

  • Responsible for deviations, product complaint investigations and GxP archives
  • Ensure training programs throughout Arena meet GxP and ICH requirements
  • Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GxP regulations and applicable country specific standards
  • Oversee compliance auditing program to fulfill regulatory requirements
  • Provide expertise and guidance to Arena departments in interpreting and implementing governmental and agency guidelines to assure compliance
  • Follow applicable regulations, including FDA, ICH, GxP, and Arena policies and procedures
  • Provide Quality Assurance input to Arena’s strategic goals in form of schedules, quality plans, and budgets

 

What we expect:

  • Bachelor’s degree, Master's degree or PhD with focus in Engineering, Life sciences, or other similar technical field
  • 15+ years of relevant and current work experience in pharmaceutical industry Quality Assurance required
  • 10+ years of demonstrated management experience with evidence of being an impactful, influential, and involved leader and mentor
  • Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority, including senior and Executive leadership
  • Solid and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment
  • Working knowledge of GxP international regulations
  • Strong organizational and time management skills
  • Attention to detail with an ability to perform critical review of various types of documents
  • Outstanding written and verbal skills
  • Ability to independently solve problems and work cross-culturally
  • Demonstrated ability to work as a team player with multi-disciplinary project teams

 

What you’ll get:

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance 
  • Matching 401k retirement plan
  • Paid time off and holidays
  • Company celebrations

 

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals, Inc.
HQ: San Diego, California

Arena Pharmaceuticals is uniquely positioned to develop best-in-disease medicines with optimized efficacy and safety for patients globally. Our drive to deliver a robust pipeline of novel, transformational medicines is grounded in two decades of world-class G protein-coupled receptor (GPCR) discovery research.

Company size: 300

  • Salary
  • Career Level
  • Degree
  • Experience
  • Job Type
  • Attractive
  • Executive
  • Bachelor's Degree
  • 10+ Years
  • Full-Time
More jobs at Arena Pharmaceuticals, Inc.
Vice President, Quality Assurance
San Diego, California
Chief Compliance Officer
Boston, Massachusetts
Associate General Counsel
Boston, Massachusetts
Director, IT Business Partner
San Diego, California

Subscribe to our newsletter

The latest news, articles, and resources, sent to your inbox weekly.