Director, Clinical Quality Assurance
Arena is looking for an individual that can successfully lead the execution of and be responsible for all aspects of the QA function. The director will primarily focus on managing all clinical QA efforts, including the continuous improvement of compliant GCP Quality Systems to ensure that Arena and outsourced third parties are inspection ready at all times.
What you’ll dive into
• Manage oversight of Arena’s Standard Operating Procedures (SOPs) and training program.
• Manage and assign resources to establish, maintain and support Arena’s GxP Quality Systems.
• Establish/implement clinical quality policies and procedures.
• Provide quality oversight of internal clinical functions and all external clinical partner quality programs, including CROs, central labs, investigator sites etc.
• Plan and conduct internal and external audits to assess compliance and performance
• Provide consultation in interpretation of regulations/guidelines as they apply to the GxP practice, awareness of regional regulatory requirements, and phase of study/phase of manufacturing process.
• Develop and provide GxP training to Arena staff.
• Serve as a liaison with QPs at third parties for labeled IMP for release and associated QP documentation.
• Provide QA oversight and approval of third party controlled documents (production batch records, change controls, deviations, CAPAs, temperature excursions etc.).
• Conduct final labeled product batch review and conduct batch release for clinical trial material.
• Provide support for the licensing (CTD/NDA/BLA or IND) approval of new products.
What we expect
• Bachelor’s Degree in Chemistry, Biology, or Life sciences/related
• 10 years’ experience with Clinical Quality Systems in the drug, biopharmaceutical or medical device fields.
• 2+ years prior auditing experience required.
• Experience in implementation and maintenance of Clinical Quality Systems.
• Demonstrated knowledge of Quality Systems and cGxP within an FDA- and EMA-regulated environment.
• Competency in MS Office, Adobe Acrobat, and quality systems databases.
• Excellent communication skills and ability to interface with vendors and organizations effectively; Negotiation and conflict management skills
• Ability to travel up to 40% of the time.
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 and 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 firstname.lastname@example.org.