Associate Director Pharmacoviligance Clinical Quality Audits

About Leads
Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com.

Job Description:
The Associate Director (AD), Quality Audits & Compliance, Clinical, Pharmacovigilance and Research (CPR) is responsible to manage Pharmacovigilance Audit program and contribute to activities in Clinical Audit program. This role is responsible for performance of domestic and international audits that ultimately ensures compliance to the appropriate level of Quality and regulatory standards (such as FDA, EMA, or MHRA). This is inclusive of internal and external audits and the successful candidate will play a major role in supporting global inspection readiness activities. This role will also contribute to planning and conduct of internal and external clinical audits.

Main Responsibilities:

• Conducts Pharmacovigilance and Clinical audits for studies and postmarketed products per EMA, FDA and MHRA regulations and guidelines.
• Plan, execute and complete Pharmacovigilance audit program based on risk assessment for all marketed products, clinical trials, vendors, and critical computerized systems and internal processes for ensuring adequate sponsor oversight in compliance EMA, FDA and MHRA regulation and guidelines.
• Audit activities include all aspects of planning, conducting, reporting, observations follow up and procedural documentation associated with internal and external audits and resource planning necessary to complete all audits. Ensure compliance to GVP, and GCP Quality Systems involving training, document management (SOPs and other controlled documents), change control, process improvement, and quality Quality systems activities will be coordinated with the Quality Systems group.
• Support regulatory inspections including, but not limited to, FDA, EMA, and other regulatory bodies as Provides management with updates and status responses to regulatory inspections.
• May act as Quality Assurance representative to assigned clinical studies and other development teams to ensure compliance with applicable regulations and industry guidance.
• Manage audit and quality systems for GVP/GCP functions including resource planning, budgeting and forecast support.
• Other duties as assigned.

Requirements:

• Bachelor's degree in a scientific field or related field.
• Minimum of 10 years as lead auditor in Pharmacovigilance and Clinical trials.
• Five (5) years of projects and audit management responsibilities in the biopharmaceutical industry.
• Must have strong background and experience in GVP/GCP compliance applicable to Global GVP and GCP regulatory requirements.
• An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Exposure and collaboration with Drug Safety and Pharmacovigilance, Clinical Development and Operations as well as Medical Affairs and commercial stakeholders for marketed products such as Patient Access Program, and Specialty Pharmacies.
• Acumen and ability in GVP/GCP auditing, FDA and EMA regulations inclusive of direct experience with Pharmacovigilance, clinical trials and System Development Life Cycle activities.
• Excellent communication skills, both verbal and written with the ability to work independently as well as in a cross-functional, multi-cultural team with limited direction.
• Strong knowledge of applicable GVP and GCP domestic and international regulations and guidelines for clinical trials.
• Knowledge of GVP and GCP applicable domestic and international compliance audit concepts.
• Ability to interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance.
• Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions. Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs, Drug Safety and Pharmacovigilance, Legal, 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 30-40% of the time.

Physical Requirements:
This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

EEO Statement:
We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn't exactly as we describe it here.