Director Quality Audits & Compliance
Acadia Pharmaceuticals
- Princeton, NJ
- Permanent
- Full-time
Do you want to continue?Search for:AboutAcadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years, we have been working at the forefront of healthcare to bring vital solutions to people who need them most.Our MedicinesLearn more about our FDA-approved treatments.PipelineWe are driven to develop innovative and novel medicines to help address unmet medical needs and to elevate life through science.Therapeutic AreasAt Acadia, we see promise in therapeutic areas where the unmet need remains high.BackBackBackBackBackBackBack› › › Job DetailMarch 26th, 2024 Quality AssuranceDirector Quality Audits & CompliancePrinceton, New Jersey, United StatesThe 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 activitiesPrimary 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.
- 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.
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance