MAPS PBC is seeking a quality assurance professional to support the maintenance and continuous process improvement of the GxP Quality System. Following MAPS PBC Quality and Compliance Leadership, the Quality Assurance Manager (QAM) will manage a team responsible for assuring that GxP activities are conducted according to applicable regulatory requirements, MAPS PBC documented policies and processes, and industry standards. In addition, the QAM will manage the team in supporting GxP quality assurance and compliance initiatives. The QAM will play a key role in the execution of QA processes, particularly related to internal, vendor, and clinical auditing. The QAM will take a hands-on approach to working with the team to efficiently meet the goals and objectives of the QA organization through risk-based approaches. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, organizational skills, and the ability to motivate internal and clinical site staff to support a positive, learning environment where creative risk-based approaches to maintaining regulatory compliance efficiently are valued. The QAM will support oversight of the MAPS PBC Quality System, which includes working with and advising QA staff and Operational Subject Matter Experts (SMEs) on quality and compliance-related scenarios related to their area of expertise and responsibilities.
Location: Santa Cruz, California (remote)
Job Type: Full-time (40 hours per week)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization.
More information about the organization is available at https://mapspublicbenefit.com.
MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.
We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, 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. MAPS PBC strives to continually improve upon the supportive, equitable, and accessible work environment.
What You’ll Be Doing
- Manage the GxP Annual Audit schedule that will include internal, vendor and protocol-specific audits.
- Manage direct report(s) to ensure ongoing execution of all assigned QA tasks, ensuring that required documentation is appropriately completed, reviewed, filed, etc.
- Manage the MAP PBC clinical and vendor audit programs and processes
- Compile, manage and present clinical and vendor quality assurance-related metric reports, as required
- Set the goals and priorities for QA direct reports; monitor success, mentoring as needed
- Advise SMEs on regulatory requirements and issues that may arise, as needed, in their areas of expertise and responsibilities
- Support the goals and directives of Quality Assurance and Compliance Leadership through execution of ongoing and new GxP QA activities
- Participate in and support the development of training material/learning solutions and training for QA and MAPS PBC staff, as needed, particularly as related to the controlled process documents and regulatory requirements.
- Execute other assigned tasks related to regulatory compliance, inspection readiness, and quality systems
- Goal-oriented, self-starter with proven ability to prioritize, take initiative, and work independently
- Strong organizational skills with ability to balance attention to details and timelines based on regulatory risk, and explain approaches to others
- Able to work quickly in a remote virtual setting
- Open to learning and growth and to supporting the growth of others
- Growth mindset and strong work ethic
What We Expect from You
- Bachelor’s Degree in a clinical or scientific field
- 5+ years’ direct experience in GxP quality control, quality assurance and/or quality management-related activities, including solid GCP quality assurance experience
- Candidate must have proven GCP QA experience as part of the five plus years of GxP QA experience required.
- Excellent knowledge of 21 CRF Parts 11 and 312, ICH E6 R2, and other applicable requirements and guidance
- Experience managing people and teams to meet shared and individual goals and objectives
- Solid understanding of basic quality and risk management concepts as well as how they apply within the pharmaceutical industry
- Proven experience planning and executing clinical investigator site audits as well as developing annual audit plans and ensuring that observations are appropriately addressed.
- General knowledge of global GxP regulatory requirements, guidance, and industry standard practices
- Strong proficiency in a range of software and systems commonly used by Quality Assurance professionals (Microsoft Software; Learning, Document, and CAPA Management Systems, etc.) and ability to quickly learn new ones
- Stellar writing and document formatting skills
- Excellent verbal communication skills; confident and influential approach
- Ability to recognize potential obstacles and manage a team to work within set timelines, conscientious and precise delivery of work even when under pressure
- Investigator site or Sponsor inspection readiness or facilitation experience strongly desired
Exempt (i.e. not eligible for overtime)
Commensurate with experience. Full benefits package including medical, dental, and vision