Director Quality Audits & Compliance @ Acadia Pharmaceuticals Inc.

Please note that this position is based in 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.

#LI-HYBRID

#LI-MS1

What we offer you (US-Based Employees):

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

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. 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.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.