Director, Clinical QA - San Diego, CA | Biospace
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Director, Clinical QA

Arena Pharmaceuticals, Inc.

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Location:
San Diego, CA
Posted Date:
7/13/2017
Position Type:
Full time
Job Code:
Salary:
Competitive
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Pharmaceutical, QA, Quality, Quality Assurance,

Job Description

Arena is looking for an individual that can successfully lead the execution of and be responsible for all aspects of the QA function. This role 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.

•   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.

Requirements

•   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.