Please note that this position is based in San Diego, CA AND/OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

The Director of Quality Audits & Compliance is responsible to independently lead, manage, and coordinate Quality GCP and GLP regulated activities and is responsible for performance of domestic and international audits/inspections that ultimately ensure 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

Primary Responsibilities

• Plan, execute and complete the audit program based on risk assessment for all clinical trials, CROs, vendors, critical computerized systems and internal processes for ensuring adequate sponsor oversight in compliance with GCP 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.
• GCP, and GLP Quality Systems responsibilities include 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.
• Will act as a representative to the clinical operations team and other development teams to ensure compliance with applicable regulations and industry guidance.
• Manage and lead audit and quality systems for GCP/GLP functions including resource planning, budgeting and forecast support.
• Other duties as assigned.

Education/Experience/Skills

Bachelor's degree in a scientific field or related field; MBA preferred. Targeting 10 years of progressive responsibility in the biopharmaceutical industry. Must have extensive knowledge of GLP/GCP audits and compliance applicable to Global GCP and GLP regulatory requirements. Familiarity with Central Nervous System (CNS) therapeutic area a plus. An equivalent combination of relevant education and experience may be considered.

• Experience with clinical development and subsequent commercialization of at least one product, small molecule preferred.
• Experience with clinical and regulated non-clinical audit
• Strong acumen and demonstrated ability in GLP/GCP auditing , FDA and EMEA regulations inclusive of direct experience with Pharmacovigilance and System Development Life Cycle activities.
• Excellent communication skills, both verbal and written with the ability to to work independently as well as in a cross-functional, multi-cultural
• Knowledge of applicable GCP and GLP domestic and international regulations and guidelines for clinical trials.
• Knowledge of GCP and GLP applicable domestic and international compliance audit concepts.
• Ability to independently 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% of the time.

Physical Requirements

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 and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.