1+ months

Director, Quality Assurance

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    114673768
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

The Director, Quality Assurance will own the internal and external audit and compliance program.

Here's an overview of the tasks and responsibilities:

Directs and implements the GxP external and internal audit program and the management of inspections and audits from external regulatory authorities. 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.

  • 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.

Interested? Heres what we need from you:

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.

Bonus points for:

  • Experience successfully commercializing new products
  • Extensive knowledge of guidelines and regulations that affect the GMP QA
  • 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

What we offer in return for all your great skills:

  • Competitive salary with annual bonus program
  • 401K with employer match for first 5%
  • 15 days starting PTO plus 15 holidays (inclusive of winter holiday shut down the week between Christmas and New Years)
  • Medical, dental, vision insurance
  • Flex Spending Accounts
  • Health Savings Account with employer contribution
  • Wellness program and an on-site fitness facility
  • Tuition reimbursement
  • Annual onsite flu shots (Employer Paid)

Whats exciting beyond that?

  • Mission driven culture our responsibilities and commitments to our customers are top priority and everyone here rallies around our common goals.
  • We stand behind our core values and hope that you find value in them too.


PI114673768

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p>The Director, Quality Assurance will own the internal and external audit and compliance program.</p> <p><strong>Here's an overview of the tasks and responsibilities:</strong></p> <p>Directs and implements the GxP external and internal audit program and the management of inspections and audits from external regulatory authorities. 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. </p> <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> <p><strong>Interested? Heres what we need from you:</strong></p> <p>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.</p> <p><strong>Bonus points for:</strong></p> <ul> <li>Experience successfully commercializing new products</li> <li>Extensive knowledge of guidelines and regulations that affect the GMP QA</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> </ul> <p><strong>What we offer in return for all your great skills:</strong></p> <ul> <li style="font-weight: 400;"><span style="font-weight: 400;">Competitive salary with annual bonus program</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">401K with employer match for first 5%</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">15 days starting PTO plus 15 holidays (inclusive of winter holiday shut down the week between Christmas and New Years)</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">Medical, dental, vision insurance</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">Flex Spending Accounts</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">Health Savings Account with employer contribution</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">Wellness program and an on-site fitness facility</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">Tuition reimbursement</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">Annual onsite flu shots (Employer Paid)</span></li> </ul> <p><strong>Whats exciting beyond that?</strong></p> <ul> <li style="font-weight: 400;"><span style="font-weight: 400;">Mission driven culture our responsibilities and commitments to our customers are top priority and everyone here rallies around our common goals.</span></li> <li style="font-weight: 400;"><span style="font-weight: 400;">We stand behind our core values and hope that you find value in them too.</span></li> </ul> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/Y78P7PHGDwQoIpLqiVeLo"> <p>PI114673768</p>

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Posted: 2019-10-18 Expires: 2019-11-18

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Director, Quality Assurance

ACADIA Pharmaceuticals
San Diego, CA 92101

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