Vice President, Quality Assurance

The opportunity

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.

The Vice President of Quality Assurance (VP QA) is responsible for leadership and direction of all aspects of the Quality Assurance function, to ensure appropriate level of compliance of the company’s clinical development activities and clinical trial material production with recognized regulations and guidelines. The VP QA will establish quality plans and policies and report compliance activities and findings to Executive leaders on a regular basis. This individual 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

• Design and maintain Quality Assurance and GxP compliance for all aspects of Arena’s programs to support clinical studies and future product registration
•  Lead, manage and mentor a large team of QA professionals with varying degrees of experience and GxP expertise
• Provide GxP Quality Assurance oversight of all external vendors’ quality programs, including CROs, central labs, investigator sites, CMSOs, and other key partners supporting clinical programs, including maintenance of quality agreements
• Write, review, approve and maintain Standard Operating Procedures
• 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 ($0 premium on select medical plans)
• Matching 401k retirement plan
• Paid time off and holidays
• Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.