Director, Quality Assurance in San Diego, CA

$200K - $250K(Ladders Estimates)

ACADIA Pharmaceuticals   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 37 days ago

Directs and implements the GxP external and internal audit program and the management of inspections and audits from external regulatory author i ties. Responsible for the creation and maintenance of vendor monitoring program and risk assessments. Responsible for planning and maintaining ACADIA's quality policies, standards, programs, and continuous improvement projects .

Primary Responsibilities:

  • Provide GMP Quality Assurance oversight of external contract service providers, including implementation and maintenance of Quality Agreements
  • Develops, Implements and maintains Internal and External Audit Program
  • Manages GxP inspections and audits from both regulatory authorities and marketing partners, and provides follow-up responses for all aspects of the business
  • Direct and manage post-audit activities including audit responses, corrective and preventative actions/ deliverables, for timely closure
  • Manage daily operations as relates to external / internal audit and supplier management functions with emphasis on continual improvement
  • Develops and maintains Quality Agreements in coordination with other TD&O functional teams
  • Support internal investigations and assures complete and accurate documentation
  • Identifies opportunities for process improvement and/or process re-design
  • Provides direction and strategy to identify, assess, and remediate quality system risks, and gaps, including conducting corporate gap assessments and development of standards
  • Partners with various key stakeholders across the organization to assess all GXP systems and standards needs and to provide resource and support for planning and execution
  • Develop effective partnerships with internal staff and external organizations to help implement proactive regulatory compliance strategies and controls
  • Promotes recognition of quality programs among internal and external customers
  • Develops and maintains Quality Policies
  • Develops and Maintains Quality Risk Management Programs
  • Develop Quality business strategies related to: Risk identification / Mitigation – Quality service providers
  • Contract Service Provider Performance Monitoring
  • Auditor Training / Qualification
  • Inspection Metrics / Trends
  • Process improvements - Internal / External Auditing
  • Lead audits and/or participate as a co-auditor in cross functional Quality audits
  • Reviews and approves documents as required, including protocols, reports, document changes, etc.

Education/Experience/Skills:

Bachelor's degree in Life Sciences Master's degree preferred. A combination of relevant education and applicable job experience may be considered. A minimum of 10 years of progressively responsible experience within QA related functions with 6 or more years directly and progressively responsible experience in GMP QA, including 3 years leading inspection readiness activities; a minimum of 6 years in a leadership role .

Must possess:

  • Thorough knowledge of best practices in quality management in pharma and other relevant industries for potential application at ACADIA
  • Thorough knowledge of external environment factors that impact ACADIA performance in clinical trials; understand drivers of success in clinical development
  • Proven success developing and executing strategy through expert understanding of the market and industry
  • Experience successfully commercializing new products
  • Extensive knowledge of guidelines and regulations that affect the GMP QA programs.
  • Excellent influencing, communication and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results
  • Proven experience interfacing with regulatory authorities, notified third party audits and either leading or being in a lead role during regulatory inspections
  • Experience with, or direct knowledge of, several quality system elements (e . g. complaints, document change control, standards and systems management, quality directive and procedures, Annual and Product Quality Review APR/PQR, Compliance related field actions, alerts and like events)
  • A proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required
  • Demonstrated success building organizations, creating and leading highly effective high performing teams
  • Adeptness at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals
  • Demonstrated analytical abilities and proficient planning and negotiation skills


Valid Through: 2019-10-8