11 days old

Director, R&D Quality Assurance

ACADIA Pharmaceuticals
Princeton, NJ 08540
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  • Job Code
    112764663

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:
Princeton, NJ


Responsible for providing input to the R&D Quality Assurance activities at ACADIA including all R&D related audits and associated quality system processes with a focus on GVP Quality Management System (QMS). The responsibilities include internal and external (contract service providers) functions and processes conducted within Good Pharmacovigilance Practice (GVP), and associated inspection readiness activities.

Primary Responsibilities:
  • Audit activities include all aspects of planning, execution, reporting, and procedural documentation associated with internal and external audits and resource planning necessary to conduct all audits. Scope includes a focus on GVP processes, service providers and associated functions .
  • GCP, GLP and GVP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality metrics. Quality systems activities will be coordinated with the GMP Quality Systems group .
  • Support for Regulatory Inspections including, but not limited to, FDA, EMA, and other regulatory bodies as required. Will provide management with updates and status of responses to regulatory inspections .
  • Will act as a representative to the clinical operations team and other development teams to ensure compliance with applicable regulations and industry guidance.
  • Management and leadersh ip for the audit and quality systems team including resource planning, budgeting and forecast support.

Education/Experience/Skills:

Bachelor's degree required, preferably in a scientific field. An equivalent combination of relevant education and applicable job experience may be considered. Minimum 10 years' of progressively responsible pharmaceutical experience in R&D quality systems , FDA and EMEA regulations with direct experience with Pharmacovigilance and System Development Life Cycle activities.
  • Experience with clinica l development and subsequent commercialization of at least one product (small molecule preferred) .
  • E x perience with Pharmacovigilance.
  • Experience directly supporting Regulatory Agency inspections .
  • Experience with pharmacovigilance audit management . GCP/GLP audit management a plus.
  • Exper i ence with organizational change management , especially as it re lat es to embracing and promoting a culture of quality .
  • Familiarity with Central Nervous System (CN S ) therapeutic area a big plus .

Must possess:
  • Knowledge of R&D quality systems.
  • Knowledge of Pharmacovigilance domestic and international regulations .
  • Knowledge of Pharmacovigilance applicable domestic and international compliance audit concepts .
  • Excellent communication skills , both verbal and written . Able to work independently as well as in a cross-functional , multi-cultural team .
  • Ability to independently interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compl i ance issues .
  • Ability to assess regulatory/compliance risk , identify areas of improvement and propose practical solutions . Frequent internal and external contacts with Development , Regulatory Affairs , Pharmacovigilance & Legal departments, Commercial, Sales and Marketing , etc .
  • Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the organization.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
  • Ability to travel 10% of the time .

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

PI112764663

</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, R&D Quality Assurance</b><br/>Location:<br>Princeton, NJ<br/><br/><br>Responsible for providing input to the R&D Quality Assurance activities at ACADIA including all R&D related audits and associated quality system processes with a focus on GVP Quality Management System (QMS). The responsibilities include internal and external (contract service providers) functions and processes conducted within Good Pharmacovigilance Practice (GVP), and associated inspection readiness activities.<br><br><u><strong>Primary Responsibilities:</strong></u><br> <ul> <li>Audit activities include all aspects of planning, execution, reporting, and procedural documentation associated with internal and external audits and resource planning necessary to conduct all audits. Scope includes a focus on GVP processes, service providers and associated functions .</li> <li>GCP, GLP and GVP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality metrics. Quality systems activities will be coordinated with the GMP Quality Systems group .</li> <li>Support for Regulatory Inspections including, but not limited to, FDA, EMA, and other regulatory bodies as required. Will provide management with updates and status of responses to regulatory inspections .</li> <li>Will act as a representative to the clinical operations team and other development teams to ensure compliance with applicable regulations and industry guidance.</li> <li>Management and leadersh ip for the audit and quality systems team including resource planning, budgeting and forecast support.</li> </ul> <br><u><strong>Education/Experience/Skills:</strong></u><br><br>Bachelor's degree required, preferably in a scientific field. An equivalent combination of relevant education and applicable job experience may be considered. Minimum 10 years' of progressively responsible pharmaceutical experience in R&D quality systems , FDA and EMEA regulations with direct experience with Pharmacovigilance and System Development Life Cycle activities.<br> <ul> <li>Experience with clinica l development and subsequent commercialization of at least one product (small molecule preferred) .</li> <li>E x perience with Pharmacovigilance.</li> <li>Experience directly supporting Regulatory Agency inspections .</li> <li>Experience with pharmacovigilance audit management . GCP/GLP audit management a plus.</li> <li>Exper i ence with organizational change management , especially as it re lat es to embracing and promoting a culture of quality .</li> <li>Familiarity with Central Nervous System (CN S ) therapeutic area a big plus .</li> </ul> <br>Must possess:<br> <ul> <li>Knowledge of R&D quality systems.</li> <li>Knowledge of Pharmacovigilance domestic and international regulations .</li> <li>Knowledge of Pharmacovigilance applicable domestic and international compliance audit concepts .</li> <li>Excellent communication skills , both verbal and written . Able to work independently as well as in a cross-functional , multi-cultural team .</li> <li>Ability to independently interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compl i ance issues .</li> <li>Ability to assess regulatory/compliance risk , identify areas of improvement and propose practical solutions . Frequent internal and external contacts with Development , Regulatory Affairs , Pharmacovigilance & Legal departments, Commercial, Sales and Marketing , etc .</li> <li>Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the organization.</li> <li>Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.</li> <li>Ability to travel 10% of the time .</li> </ul> <br><em>ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br> <img src="https://analytics.click2apply.net/v/j7neNKUNdJo4HRZ6uxyPa"> <p>PI112764663</p>
Posted: 2019-08-13 Expires: 2019-09-14

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Director, R&D Quality Assurance

ACADIA Pharmaceuticals
Princeton, NJ 08540

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