November 3rd, 2022 Quality Assurance - GCP

Director R&D Quality Assurance

San Diego, California, United States

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Acadia is looking to bring on a Director of R&D Quality Assurance who will be responsible for providing input to the activities at Acadia, including all R&D-related audits and associated quality system processes within the GCP and GLP Quality Management System (QMS)! The GCP, GLP audit responsibilities include internal and external (contract service providers) functions and processes conducted within Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and applicable Computer System Validation regulations as required by all relevant regulatory agencies.

Primary Responsibilities:

  • Plan, implement and complete the audit program based on risk assessment for all clinical trials, CROs, vendors, critical computerized systems, and internal processes to ensure adequate sponsor oversight in compliance with GCP regulations and guidelines.
  • Audit activities include all aspects of planning, execution, reporting, and procedural documentation associated with internal and external audits and resource planning vital to conduct all audits.
  • GCP and GLP Quality Systems' responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality metrics. Quality systems activities will be coordinated with the GMP Quality Systems group.
  • Support for Regulatory Inspections including, but not limited to, FDA, EMA, and other regulatory bodies as required. Will provide management with updates and status of 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 mentorship.
  • Management and leadership for the audit and quality systems team, including resource planning, budgeting, and forecast support.

Education/Experience/Skills:

  • Bachelor's degree required, preferably in a scientific field. An equivalent combination of relevant education and applicable job experience may be considered.
  • A desired 10 years of dynamically responsible pharmaceutical experience in R&D quality systems, FDA and EMEA regulations with direct experience with Pharmacovigilance and System Development Life Cycle activities.
  • Hands-on experience with clinical development and subsequent commercialization of at least one product (small molecule preferred).
  • Experience in GCP, GLP regulations and guidelines, and, when applicable, GCLP guidelines.
  • Experience directly supporting Regulatory Agency inspections.
  • Experience with clinical and regulated non-clinical audit management.
  • Experience with organizational change management, especially in adopting and promoting a culture of quality.
  • Familiarity with Central Nervous System (CNS) therapeutic area is a big plus.

Must possess:

  • Knowledge of R&D quality systems as applicable to GCP and GLP regulatory requirements.
  • Knowledge of applicable GCP and GLP domestic and international regulations and guidelines for clinical trials and compliance audit concepts.
  • Excellent communicator, both verbal and written. Able to work independently as well as in a cross-functional, multi-cultural team.
  • Ability to independently interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance issues.
  • Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions. Frequent internal and external contacts with Development, Regulatory Affairs, Pharmacovigilance & Legal departments, Commercial, Sales and Marketing, etc.
  • Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the
  • Proficient at crafting and communicating a clear vision among team members, efficiently aligning resources and activities to achieve functional area and/or organizational goals.
  • Ability to travel 10% of the time.
  • The employee must be fully vaccinated against Covid-19 in accordance with our policy.
  • Must reside in the United States

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. The employee must occasionally lift and/or move up to 15 pounds. Employee must be fully vaccinated against Covid-19 in accordance with our policy and in order to meet any independent vaccination requirements that our clients and client facilities may have.

#LI-Hybrid #LI-MH1

 

What we offer you:

  • 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:

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.