Manager Quality Assurance R&D @ Acadia Pharmaceuticals Inc.

This role will work closely with Research and Development (R&D) to assist in the planning, scheduling, and oversight of audits. They will collaborate internally and externally with clinical investigator sites, Contract Research Organizations (CRO), and vendors for studies and activities in compliance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP). This individual will also support audit/CAPA activity timeline management, review of proposed audit observation/CAPA responses and proposed actions, as well as provide Quality support across various indications.

Primary Responsibilities

Manage and track the R&D Quality Assurance (QA) Audit timelines and activities
Participate and contribute to User Requirement Assessments and User Acceptance Testing (UAT) for general technology implementation
Build ad-hoc metrics and trends specific to R&D QA activities to ensure related SOP requirements are fulfilled and to demonstrate process improvement
Assist each QA lead in planning and tracking timelines for audits and CAPA activities. This includes managing the receipt of action implementation deliverables from Contractor Service Providers (CSP) and internal auditees
Assist each QA lead in managing consulting auditor onboarding, training, and system access
Assist in the review or creation of Controlled Documents (e.g. SOPs, Work Instructions), tools, and templates
Assist in the creation, maintenance and updating of the Master Schedule
Assist the QA lead in the review and assessment of audit observation responses from internal process audits, clinical trial sites, preclinical studies and facility sites, CROs and CSPs to ensure completeness and appropriate remediation and preventative activities have been identified and implemented
Other duties as assigned

Education/Experience/Skills

Requires a Bachelor’s degree or equivalent experience in a related field
Targeting 5 years of progressively responsible experience within the pharmaceutical or biotechnology industry, including GLP, GCP, and GVP regulations or equivalent experience
Knowledge of base-level Quality Assurance principles
Proficiency in Microsoft Office suite
Proven experience in time management and written communication
Experience with or knowledge of basic Computer System Life Cycle management and principles
Ability to drive standards and change across functional areas and sites
Strong attention to detail in establishing priorities, scheduling, and achieving deadlines
Ability to work independently, take initiative, and complete tasks
Excellent interpersonal, communication, analytical, and organizational skills

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 issues.

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.