29 days old

Director, Quality Assurance

ACADIA Pharmaceuticals
San Diego, CA 92101
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  • Job Code
    112237470

ACADIA Pharmaceuticals

U.S. Equal Opportunity Employment Information
In keeping with our commitment to the community in which we do business, and in compliance with state and federal law, ACADIA is an equal opportunity employer. Our employment policies and procedures ensure that we are committed to providing equal employment opportunities in all aspects of employment without unlawful regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, veteran's status, marital status, medical condition, and physical or mental disability. As an equal opportunity employer, we hire without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. We invite you to complete the optional self-identification fields below used for compliance with government regulations and record-keeping guidelines.


Location:
San Diego, CA - HQ


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

PI112237470

</br><b>ACADIA Pharmaceuticals</b></br></br>U.S. Equal Opportunity Employment Information <br> In keeping with our commitment to the community in which we do business, and in compliance with state and federal law, ACADIA is an equal opportunity employer. Our employment policies and procedures ensure that we are committed to providing equal employment opportunities in all aspects of employment without unlawful regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, veteran's status, marital status, medical condition, and physical or mental disability. As an equal opportunity employer, we hire without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. We invite you to complete the optional self-identification fields below used for compliance with government regulations and record-keeping guidelines.<br/><br/><bDirector, Quality Assurance</b><br/>Location:<br>San Diego, CA - HQ<br/><br/><br>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 . <br><br><u><strong>Primary Responsibilities:</strong></u><br> <ul> <li>Provide GMP Quality Assurance oversight of external contract service providers, including implementation and maintenance of Quality Agreements</li> <li>Develops, Implements and maintains Internal and External Audit Program</li> <li>Manages GxP inspections and audits from both regulatory authorities and marketing partners, and provides follow-up responses for all aspects of the business</li> <li>Direct and manage post-audit activities including audit responses, corrective and preventative actions/ deliverables, for timely closure</li> <li>Manage daily operations as relates to external / internal audit and supplier management functions with emphasis on continual improvement </li> <li>Develops and maintains Quality Agreements in coordination with other TD&O functional teams</li> <li>Support internal investigations and assures complete and accurate documentation</li> <li>Identifies opportunities for process improvement and/or process re-design</li> <li>Provides direction and strategy to identify, assess, and remediate quality system risks, and gaps, including conducting corporate gap assessments and development of standards</li> <li>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</li> <li>Develop effective partnerships with internal staff and external organizations to help implement proactive regulatory compliance strategies and controls</li> <li>Promotes recognition of quality programs among internal and external customers</li> <li>Develops and maintains Quality Policies</li> <li>Develops and Maintains Quality Risk Management Programs</li> <li>Develop Quality business strategies related to: <ul> <li>Risk identification / Mitigation - Quality service providers</li> <li>Contract Service Provider Performance Monitoring</li> <li>Auditor Training / Qualification</li> <li>Inspection Metrics / Trends</li> <li>Process improvements - Internal / External Auditing </li> </ul> </li> <li>Lead audits and/or participate as a co-auditor in cross functional Quality audits</li> <li>Reviews and approves documents as required, including protocols, reports, document changes, etc.</li> </ul> <br><u><strong>Education/Experience/Skills:</strong></u><br><br>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 .<br><br>Must possess:<br> <ul> <li>Thorough knowledge of best practices in quality management in pharma and other relevant industries for potential application at ACADIA</li> <li>Thorough knowledge of external environment factors that impact ACADIA performance in clinical trials; understand drivers of success in clinical development</li> <li>Proven success developing and executing strategy through expert understanding of the market and industry</li> <li>Experience successfully commercializing new products</li> <li>Extensive knowledge of guidelines and regulations that affect the GMP QA programs.</li> <li>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</li> <li>Proven experience interfacing with regulatory authorities, notified third party audits and either leading or being in a lead role during regulatory inspections</li> <li>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)</li> <li>A proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required</li> <li>Demonstrated success building organizations, creating and leading highly effective high performing teams</li> <li>Adeptness at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals</li> <li>Demonstrated analytical abilities and proficient planning and negotiation skills</li> </ul> <img src="https://analytics.click2apply.net/v/BXoLOasKjoPpCpB2iR7nk"> <p>PI112237470</p>
Posted: 2019-07-24 Expires: 2019-08-25

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Director, Quality Assurance

ACADIA Pharmaceuticals
San Diego, CA 92101

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