Associate Director, QA Quality Systems (QMS) in San Diego, CA

$150K - $200K(Ladders Estimates)

Arena Pharmaceuticals, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 40 days ago

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.

We are seeking an Associate Director QA, Quality Systems (QMS) reporting to the Director QA, GxP Quality Systems. This individual will be responsible for managing the QMS with initial focus on Change Control, CAPA, Deviations and Investigations to ensure compliance with regulations and standards set forth by governing regulatory and accrediting agencies. They will be interacting with cross-functional groups, project teams and Contract Manufacturing Organizations (CMO) and Contract Service Providers (CSP) to meet quality and business objectives.

What you'll dive into:

  • Lead the development, implementation, maintenance and continuous improvement of Arena's Quality Management Systems with initial focus on Change Management, CAPAs, Deviations and Investigations
  • Author/revise QMS program SOPs to align with current business model and industry expectations/trends
  • Author, review and approve documents to ensure compliance with applicable internal and external requirements, (e.g. change controls, CAPAs, root cause investigations, deviations,) consistent with cGMPs and quality compliance best practices
  • Assist management with development of quality plans, functional objectives and key results
  • Provide support in preparation, management and follow-up activities associated with site visits of regulatory agency preapproval inspections (inspection readiness program)
  • Serve as the Subject Matter Expert during regulatory inspections for relevant quality systems
  • Manage day-to-day operations of Change Management, CAPAs and Deviations in both paper-based and electronic systems, and other systems as assigned
  • Participate in the organization of ad hoc Material Review Boards to ensure cross-functional discussion and evaluation of information to be considered to determine disposition of GMP materials such as drug substance, drug product, clinical trial material, packaging and labeling, GMP materials exposed to unexpected and unplanned conditions; support documentation of risk mitigation plans and the initiation of determined action items.
  • Oversee the Change Management Program and utilize Quality Risk Management to evaluate proposed changes, ensure timely initiation of cGMP change controls, perform quality assessments, assist with identification of required activities, confirmation of implementation activities and regulatory assessments to assess impact to submissions; ensure appropriate closure activities are performed; development of key compliance and performance metrics to provide relevant data for process monitoring and the reporting of program metrics
  • Oversee the CAPA program and provide guidance on CAPA Plan development by ensuring investigations are thoroughly conducted and complete with root cause, corrections, and corrective/preventive actions identified; conduct quality review and approval of CAPAs. Track status to completion, including CAPA effectiveness; development of key compliance and performance metrics to provide relevant data for process monitoring and the reporting of program metrics
  • Oversee the Deviation program and determine if deviations require root cause analysis and/or CAPAs and facilitate root cause investigations
  • Develop a risk-based approach to conducting investigations
  • Implement use of quality tools, such as 5-Whys, Failure Mode Effects Analysis (FMEA), Cause and Effect Diagrams, Process Mapping, etc.
  • Serve as the Quality lead for various QMS projects; represent Quality on multidisciplinary teams
  • Develop processes for use of an electronic Quality Management System (QMS) (e.g., Veeva Quality Suite QMS), including building workflows
  • Develop effective partnerships with internal staff and external organizations to facilitate the identification and resolution of quality matters and other opportunities for quality process improvements
  • Develop and conduct training for the Quality Team and other personnel with regards to change management, CAPAs, deviations and other systems as assigned
  • Lead manage and mentor personnel: responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work, appraising performance; rewarding, developing and coaching employees; addressing complaints and resolving problems. Proactively support Arena's organizational values
  • Responsible for timely updates of functional group achievements and challenges to management with a focus on operational performance, staff performance and productivity, staff development, continuous improvement, key project support and identification and resolution of obstacles to maintaining an effective and efficient team
  • Manage the compilation, review, and trending of quality systems metrics for Management Review and operational metric reporting

What we expect:

  • BS degree in a scientific discipline with 10+ years related experience in GxP-regulated biotech/pharmaceutical/medical device industries
  • Working knowledge of GxP regulations including, but not limited to: 21 CFR Parts 210/211, 21 CFR Part 11, Eudralex – Volume 4, ICH Q9, ICH Q10, Data Integrity
  • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
  • Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner
  • Must possess excellent verbal and written communication skills
  • Ability to achieve objectives with minimal oversight or direction
  • Ability to use critical thinking, resolve issues, and deal with a variety of variables in situations where general standardization does not yet exist
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  • Strong follow-up and organizational skills
  • Ability to identify situations which will require senior management intervention for resolution
  • Must possess proficient knowledge of Microsoft Word, Excel, Access and other systems such as Smartsheet, and SharePoint
  • Ability to use Electronic Document Management Systems. Experience using/administering an electronic QMS (e.g., Veeva Quality Suite QMS) is a plus
  • Must be able to maintain confidentiality

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

Valid Through: 2019-10-7