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Head of GCP Quality & Compliance MAPS PBC – Santa Cruz, CA

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.

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

MAPS PBC is a dispersed workforce that offers full-time employment in a dynamic remote work environment. This means our employees enjoy competitive salaries and benefits packages, as well as the comfort of working from their own homes. Through the conscious use of technology, we stay connected to our team members and professional community while, at the same time, enjoying the freedom of a remote environment.

We are committed to conscious leadership and an inclusive team dynamic. Our culture is one of mutual respect, responsibility, and trust. Our employees’ health and happiness are priorities, and we treat our staff like people, not numbers on a spreadsheet.

MAPS PBC is at the forefront of changing the way mental health issues are treated and is committed to bringing dignity and access to overcoming mental health challenges through the conscious use of psychedelics. We believe we are changing the world, and we want you to be a part of it.

Position Summary

Reporting to the Chief Operating Officer (COO), the Head of Clinical Quality Assurance (QA) will have oversight of the implementation and ongoing execution of MAPS PBC Quality System and Quality Assurance activities. The Head of Clinical QA will be responsible for developing and implementing global strategy and policy relative to quality management systems for MAPS PBC to ensure data integrity and patient safety following global GxP regulatory requirements and industry standards. In addition, ensures that internal controls are implemented and evaluated for compliance via audits and assessments across the MAPS PBC functions to minimize regulatory, legal, and business risk while effectively and efficiently supporting business goals. Develops auditing/inspection strategies for MAPS PBC activities and provides management with in-depth analysis and risk management on quality matters. Leads team of Quality Assurance & Compliance professionals, setting and communicating the vision for the team and fostering a culture of collaboration.

Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided.

The MAPS PBC headquarters office is located in Santa Cruz, CA. This position requires up to 40% travel

Hours

Full-time, 40 hours per week. We are a West Coast-based company and applicants must be available during normal business hours (9:00 AM – 6:00 PM Pacific Time, Monday through Friday). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

Essential Job Functions

  • Defines quality objectives and strategies to meet MAPS PBC goals and objectives
  • Facilitates groups or teams through the problem-solving and creative-thinking processes leading to the development and implementation of new approaches, systems, structures, and methods to ensure overall quality processes and services across the organization
  • Generates creative new solutions and approaches to customer issues and organizational quality processes
  • Leads and manages processes that provide oversight and guidance to monitor and assure compliance with quality management system requirements and all applicable good practice regulations, i.e. clinical (GCP); Pharmacovigilance (GPvP); Laboratory (GLP), Risk Evaluation Mitigation Strategies, application validation relating to MAPS PBC regulated activities.
  • Effectively manage the development, implementation, approval and maintenance of quality assurance systems and processes
  • Ensures MAPS PBC procedures, Standard Operating Procedures (SOPs), guidelines, and other standard materials required for departmental function are prepared, reviewed and that staff are trained
  • Ensures that annual audit risk-based plans are developed and executed
  • Interprets global legislation, regulations, and guidance’s for MAPS PBC to develop policies and standards, identify gaps and redundancies and coordinate and implement remediation in collaboration with MAPS PBC management and other cross-functional teams (i.e legal, HR, IT).
  • Serves as direct interface for MAPS PBC during regulatory inspections (FDA, EMA, MHRA/Health Canada)
  • Verifies that appropriate follow-up and corrective action is taken because of audit observations and investigations and that corrective actions are reviewed and analyzed to identify process improvement initiatives
  • Reviews and approves quality agreements between MAPS PBC and vendors
  • Escalation point for any quality assurance issues that have a significant impact on overall study or program timelines, other functions, budget, or clinical operations
  • Present and provide annual budgets for all QA systems, hiring, procedures and department expenses aligned with the overall business strategy
  • Responsible for developing the hiring strategy, appropriate organizational structure, resource plans and culture to support the quality assurance and compliance teams

Knowledge, Skills, and Abilities

  • Excellent interpersonal skills and the ability to communicate effectively across all levels of the organization
  • Patience and attention to detail with proven people management experience
  • Ability to work independently while being an effective team player with the ability to work across functional lines in a collaborative way
  • Open and clear communicator with excellent written and verbal communication skills
  • Confident and influential approach
  • Self-motivating, able to prioritize and take initiative, make informed decisions and take responsibility for actions
  • Possess sound judgment, discretion and be detail orientated
  • Able to understand the needs of others
  • Strong organizational skills with attention to details and timelines
  • Able to work quickly in a remote virtual setting
  • Coordination and planning of tasks and time management
  • Recognize potential obstacles and work within set timelines
  • Conscientious and precise delivery of work even when under pressure

Minimum Requirements

    • Bachelor’s Degree in a life science field; advanced degree in a scientific discipline preferred
    • Generally, has at least 15 years of pharmaceutical industry/drug development experience with at least 8 years of compliance and process management experience, and at least 5 years management experience of a global team; or equivalent combination of education and experience
    • Excellent knowledge of global GxP practices required – Good Clinical Practices, Good Pharmacovigilance Practices, European Medicine Agency requirements, as well as regulatory requirements regarding computerized systems (21 CFR Part 11 and EU Annex 11) used for regulatory submission
    • Excellent interpersonal skills and the ability to communicate effectively across all levels of the organization
    • Good analytical and organizational skills.
    • Effective team player and the ability to work across functional lines in a collaborative way.
    • The ability to work autonomously with minimal supervision
    • Excellent knowledge of global GxP practices required – Good Clinical Practices, Good Pharmacovigilance Practices, European Medicine Agency requirements, as well as regulatory requirements regarding computerized systems (21 CFR Part 11 and EU Annex 11) used for regulatory submission

General Responsibilities:

  • Communicates and collaborates with key players, internal and external staff
  • Checks in regularly with supervisor and complete assignments by agreed deadline
  • Proactively seeks methods of improvement, streamlining workflows and building efficiencies in individual work and project outcomes

FLSA Status

Exempt (i.e. not eligible for overtime)

Compensation

Commensurate with experience. Full benefits package including medical, dental, and vision.

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