Vice President, Quality Assurance

San Diego, California | Full-Time

Job viewed98,873times

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
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