Responsible for the oversight of the Research and Development, Pharmacovigilance, Translational Medicine, Medical Affairs and Regulatory operational aspects of Quality Management activities in support of Acadia worldwide and in fulfillment of global legislation and regulations. This is accomplished through development and execution of global processes, standards, training programs and compliance monitoring. Member of the Quality Management leadership team.
- Leadership of Quality Management Operational Activities: Ensures compliant Quality Management processes are in place e.g. appropriate processes for assuring compatibility with job description roles, SOP roles and training curriculum for R&D, Translational Medicine, Regulatory Affairs, Medical Affairs and Pharmacovigilance. Ensures effective system to monitor compliance with reporting requirements including root cause and corrective/preventive actions. Generates and conducts training for the above departments, particularly around GLP, GCP and GVP for inspection readiness. Serves as primary liaison with all departments listed to coordinate and collate assignments and responses to global Health Authority inspections for on time response. Drives implementation of quality standards across other areas that provide input into the QMS such as clinical research, medical affairs commercial, etc. Ensures internal and external audit deficiencies are communicated to functional heads including preparation, prioritizing and monitoring of mitigation activities to ensure closure of findings. Provides input to business regarding needs associated with globalization of Acadia products and potential acquisitions.
- Quality Management System Leadership: Contributes to the management of Acadia’s global Quality Management System (QMS). Identifies the need for and recommends additional or alternative technologies to meet business needs. Identifies areas of opportunity including areas that would benefit from improvement of the QMS. Contributes to the reports which keeps Acadia Leadership apprised of the compliance status.
- Quality Management Leadership: Serves as a member of the Quality Management leadership team to influence the operations of Quality Management. Alerts senior management of significant deficiencies in quality and compliance standards and ensures corrective/preventive actions are implemented.
- Strategic Leadership: Works collaboratively and effectively with colleagues across Acadia to contribute to meeting organizational goals and objectives.
- Bachelor of Science degree, graduate degree in scientific discipline desirable.
- Experience with quality management systems. Drives compliance oversight to SOPs, training, JD’s, etc. to assure consistency and compliance across R&D, Translational Medicine, Pharmacovigilance, Regulatory and Medical Affairs. Will establish tracking and reporting of performance to the above organizations and work with each to bring within compliance. Develops and maintains SOPs in the Quality Management Operations area.
- A minimum of 12 years in industry with 8 years in Quality and/or Compliance across product development.
- Experience working with Commercial and Legal organizations reviewing contracts is a plus.
- Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pre-clinical, clinical, post marketing and pharmacovigilance.
- Must have experience with industry interpretation of regulatory expectations and with preparation for and management of company inspections by major global Health Authorities.
- Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice, and make decisions.
- Understanding of computer system validation.
- Strong attention to detail in establishing priorities, scheduling, and meeting deadlines.
- Ability to work independently, take initiative, and complete tasks to deadlines.
- Excellent interpersonal, communication, analytical, and organizational skills.
- Demonstrated ability to motivate, lead, and train others.
- Proficient computer skills, including Microsoft Word, PowerPoint and Excel.
- Experience with Veeva suites and Compliance-Wire is a plus.
Leads and drives Quality Management business process initiatives to achieve goals in accordance with established policies, meet schedules and overcome challenges; provide direction to and review of resources and personnel across Quality Management functions. Works on abstract problems that may cut across-functional areas and require cross-functional input. Interacts with management on matters concerning Quality Management. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity