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 Therapy by the FDA and the results of our pivotal Phase 3 clinical trial were published in Nature Medicine or 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.
GMP Quality Director Executive Summary
The scope of this leadership role includes oversight of GMP activities for MAPS PBC and its contract development and manufacturing organizations (CDMOs), suppliers, testing laboratories, and logistics vendors. The Director of GMP QA is accountable for ensuring that vendors are compliant with global regulations, prepared for potential Regulatory Inspections and that the appropriate processes, systems and activities are in place and performed to protect patient safety, product quality, and data integrity.
This is an exciting, interdisciplinary role for a highly qualified and motivated individual. The successful candidate will have a strong understanding of GMP Quality for raw materials, drug substance, drug product, labeling and packaging, including QC testing, stability, and Clinical Trial Material (CTM) distribution. Commercialization and launch experience strongly preferred. This expertise, along with drug development background and the organizational and interpersonal skills required to build and foster strong relationships with collaborators, will be needed for success. The ideal candidate will demonstrate the ability to be both detail oriented and to think strategically.
This individual will work to develop and continuously improve GMP quality processes and to support the state of GMP compliance at all MAPS PBC CDMOs. The position will focus initially on GMP Quality build-out to strengthen Clinical-phase Quality Systems. Systems and processes developed will accommodate global and commercial Quality system requirements. Pre-approval and routine Regulatory inspection readiness to prepare for audits by global Regulatory Health Authorities will be a key success factor.
- Oversee regulated activities: develop and implement internal standards and processes to ensure compliance with worldwide regulatory requirements for cGMP, FDA, ICH and EMEA. Deliver audit ready programs for internal and external inspections in these respective areas.
- Drive risk-based Quality strategies: create and launch strategies in preparation for investigational and commercial materials with the establishment and maintenance of phase appropriate quality systems while proactively identifying and mitigating quality risks.
- Manage Quality agreements: establish and maintain quality agreements with CDMOs, suppliers, testing laboratories, and logistics vendors with assurance of compliance to regulatory standards.
What you bring to the role:
- Minimum BS degree in science, engineering, or related field, advanced degree is a plus.
- 10 years of applicable pharmaceutical drug development experience with at least 7 years of Quality Assurance experience including comprehensive knowledge of EU GMP and US GMP regulations.
- Experience with product commercialization/launch an advantage.
- Proven experience with QMS activities – implementing and managing QMS systems, handling deviations, change controls and OOS, overseeing CAPAs, and executing/managing audits of suppliers and internal functions.
- Useful background could include experience with small molecules and filing of an NDA.
- Knowledge and demonstrated experience of analytical QA, Regulatory Inspections, including PAI.
- Close working relationship/experience with CDMOs.
- Experience authoring Quality procedures.
- Track record of delivering in a start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.
- Direct experience in successfully managing Health Authority Inspections and responsibilities concurrently.
- Strong working knowledge of global GxP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.
- Cover letter required; incomplete applications may not be considered.
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
- Wellness Wednesday/Journal Club/Yoga/Meditation and so much more!