For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.
Responsible for implementing, supporting and maintaining the good R&D practice standards to infuse quality, promote compliance mindedness, improve efficiency, and enhance risk management within ACADIA Pharmaceuticals. Informs and executes process improvements and plays a key role with the entire Inspection Readiness Program to identify, address, and mitigate compliance risk areas related to any Company late-phase asset. Serves as the compliance expert, and provides leadership, in GCP and GLP compliance.
Responsible for assisting in the management the Master Audit Plan for R&D Quality Assurance to schedule all assigned audits, eg, CSP, Investigator Sites, Documents, and eTMF. Functions as R&D QA study Lead to ensure study specific investigator site audits are included within the MAP. Participates in cross functional internal process improvement initiatives and interfaces with other Quality groups within ACADIA to support overarching quality assurance
- Plans, schedules, conducts and reports external audits (i.e. clinical investigator sites, contract service providers) globally or domestically
- Communicates audit findings via audit debrief meetings with the appropriate personnel at ACADIA to ensure understanding of findings.
- Participates in the evaluation of R&D quality issues and provides recommendations.
- Provides pertinent data to support quality and compliance metrics and trending
- Participates, as appropriate in the evaluation of ACADIA’s Quality System and processes for optimization and continuous improvement
- Monitors, assesses and interprets domestic and global regulatory requirements related to R&D activities.
- Provides guidance in the creation, review and revisions to standards (e.g., SOPs, Work Instructions).
- Participates in components of the corporate Inspection Readiness Program, which can entail concurrent projects for multiple assets.
- Participates in inspection coordination (preparation, conduct, and response) for GCP/BIMO and GVP post marketing inspections.
- Partners with various internal and external groups to analyze R&D compliance/quality issues globally and/or domestically, identifies and communicates options, and recommends and assists with development of appropriate solutions.
- Develops and provides GCP and GLP and related training in support of compliance systems and quality improvement initiatives within the organization.
- Other duties as assigned/required.
Bachelor’s degree in Life Sciences. Minimum of 5 years direct and progressively responsible experience in the pharmaceutical industry in Clinical Development in a combination of the following areas: Quality, Clinical Operations, and/or Regulatory Affairs. Pharmacovigilance auditing experience is a plus.
- Auditing experience and review of regulatory filings
- Experience with interacting with third parties (e.g., contract service providers).
- Experience with FDA, EMA, and other regulatory regulations as required.
- Experience in managing concurrent complex projects/programs (e.g. process improvement initiatives, clinical projects).
- Direct experience in R&D compliant quality systems.
- Excellent communication skills including: technical writing skills, PC skills, and critical thinking and analysis.
- Ability to work effectively in a team environment and with individuals at all levels within an organization.
- Ability to manage concurrent complex projects/programs.
- Ability to interpret and relate Quality standards for implementation and review.
- Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
- Ability to gain cooperation of others.
- Skills at effectively leading a cooperative team effort and organizing resources to achieve team goals.
- Ability to make and prioritize process and resource decisions based on overall team needs.
- Proficiency with computer skills, including Microsoft Word and Excel.
- Travel of 25% to 50% may be required.
May provide guidance to subordinates and/or manage department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity