Director/Sr Director, GCP/GLP Quality Assurance

San Diego, California
Feb 07, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Opportunity
The Director/Sr. Director of GCP/GLP Quality Assurance will be responsible for leadership and direction of all aspects of the GCP/GLP QA function.  This role has responsibility for oversight of day-to-day GCP/GLP QA operations, including audit program management; clinical and pre-clinical study team support; GCP/GLP SOP development and review; regulatory inspection support; and general QA support to ensure Arena is in compliance with regulations, guidelines and corporate policies and procedures. 

What You'll Dive Into
• Represent QA and interface with multiple departments and external providers to provide GCP/GLP guidance in an effective, constructive and timely manner
• Coordinate, oversee, and/or conduct external and internal GCP/GLP audits to ensure compliance with applicable regulations, guidelines, protocols, and Standard Operating Procedures (SOPs)
• Establish and implement GCP/GLP quality policies and procedures
• Provide consultation on, and interpretation of, regulations, guidelines, compliance status and policies and procedures to project teams
• Provide quality oversight of all external clinical and pre-clinical partner quality programs
• Ensure the planning and conduct of internal and external audits to assess compliance with Arena’s procedures and GCP/GLP regulations
• Enhance and maintain metrics, including trending of data, for internal and external audit performance and compliance
• Ensure development and provision of GCP/GLP training to Arena staff, as applicable
• Provide support for the licensing (CTD/NDA/BLA or IND) approval of new products
• Keep abreast of industry developments – forthcoming regulations, competitor activity, etc. – and ensure information is disseminated appropriately within Arena
• Serve as an SME for areas of responsibility during regulatory inspections
• Propose and implement improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies
• Support corporate and third party inspection readiness activities
• Provide support and contribute to other Quality Assurance activities as necessary

What We Expect
• Bachelor’s Degree in Life sciences, or related discipline
• 10 years’ experience with Clinical and Pre-Clinical Quality Systems in the drug, biopharmaceutical or medical device fields
• 4+ years prior auditing experience required
• 2+ years of direct line management experience
• Experience in implementation and maintenance of Quality Systems
• Comprehensive knowledge of current domestic and international GCP/GLP regulations
• Competency in MS Office, Adobe Acrobat, and quality systems databases
• Excellent communication skills and ability to interface with internal and external customers effectively
• Proficient negotiation and conflict management skills
• Ability to handle multiple assignments in a fast-paced environment with changing priorities
• Ability to travel up to 25% of the time (US & International)

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 including a Summer & Winter break
• 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