Quality Associate

Remote (United States)

MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD. MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. It has been designated a Breakthrough Therapyby the FDA and the results of our pivotal Phase 3 clinical trial were published in Nature Medicine and profiled on the front page of The New York Times.  


MAPS PBC is a Public Benefit Corporation, with a dual mandate to generate shareholder value and public benefit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics. We are committed to continuing to lead the field of psychedelic medicine with integrity and ethics at the core.  


Why work for MAPS Public Benefit Corporation (MAPS PBC)? 


· We are a diverse team that shares a deep belief in the critical need for innovation and expanded access in the treatment of mental health conditions.

· We are entrepreneurial, collaborative, and open-minded in how we approach our innovative work. 

·  We are a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency. 


We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment. 

Quality Associate

The Quality Associate will report directly to the Director of GxP Audit Program. The Quality Associate will be responsible for supporting the management of the risk-based audit program for internal, external, and vendor audits for compliance to MAPS PBC policies, procedures, and GxP regulatory requirements. The Quality Associate will contribute in scheduling, authoring reports, CAPA tracking, and maintaining compliance metrics for GLP, GCP, and pharmacovigilance audits for pivotal clinical programs, vendors, and systems. The position collaborates with business leaders and directors to obtain input on audit plans, reports, and follow up on CAPA completion. The Quality Associate will be a critical role in support of the quality management system for MAPS PBC.


Must be able to work under pressure at times to handle a wide variety of activities, maintaining confidential matters with discretion. This position is often privy to confidential information and as such, requires diplomacy and discretion.


  • Support the Director of GxP Audit Program with executing the risk-based audit program strategy for audits of clinical sites, submission documentation, internal processes, and vendors
  • Assist in the creation and maintenance of audit schedules, assign tasks, and conduct audits per plan 
  • Implement and maintain the procedures, work instructions, and systems used to execute the audit program
  • Collaborate with internal and contract audit staff, conduct training as needed
  • Author reports and assist with root cause analysis and the development of CAPA plans, communicate findings to relevant stakeholders
  • Support vendor selection qualifications and routine audits
  • Support the completion of internal audits of processes and systems with discretion and in support of a quality by design and continuous improvement culture
  • Provide training sessions based on audit/inspection data and participate in process improvement activities in support of proactive quality and continuous improvement
  • Assist in the facilitation of inspections and inspection readiness activities
  • Support risk management activities with audit/inspection data
  • Participate in quality team projects, quality events, initiatives, and cross-departmental engagements to promote a sustained risk-based quality management culture for MAPS PBC

Minimum Requirements

  • Bachelor's degree with minimum 4 years of experience from pharmaceutical, biotech industry with at least 2 years of auditing
  • Any equivalent combination of experience, and/or education from which comparable knowledge, skills and abilities have been achieved.
  • Knowledge of GCP, GLP, and Pharmacovigilance standards
  • Knowledge of FDA and EU regulatory requirements
  • Ability to author and review quality audit reports
  • Full time remote position with up to 20% travel (domestic and international)
  • Experience supporting leadership working in a pharmaceutical and start-up environment
  • Skilled at working within an entrepreneurial environment that is mission-driven, results-driven, and research-oriented
  • Ability to exercise good judgment in a variety of situations
  • Excellent written and verbal communication
  • Highly detail oriented and organized
  • Willing to work in a fast-paced dynamic environment subject to quickly changing priorities and potentially conflicting deadlines  
  • Serviceability to work independently and within a team structure
  • Self-motivating, able to prioritize and take initiative
  • Experience using Microsoft Office, PowerPoint, Asana, Smartsheet, Adobe Sign and Zoom
  • A desire to work in a truly collaborative team

MAPS PBC is a distributed team that uses technology and periodic in-person gatherings to stay connected. We look for people who are comfortable with and skilled at remote work and collaboration.  

Competitive benefit package includes: 

Paid Time Off (PTO)

Sick Time

Holiday Pay

Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)

Employer funded mental health HRA

Employer funded SEP IRA

FSA/Dep Care

Pet Insurance

Home Office Stipend

Conscious culture offering guided meditations, yoga and psychedelic ecosystem dialogues

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