Associate Director of Quality Assurance - Remote Position

Quality Assurance · Any City, Any State, California
Department Quality Assurance
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

About MAPS Public Benefit Corporation (MAPS PBC)

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:
MAPS PBC is seeking a GCP quality assurance professional to support the maintenance and continuous process improvement of the GxP Quality System. Following MAPS PBC Quality and Compliance Leadership, the Associate Director, Quality Assurance (ADQA) is responsible for managing the QA system to assure that GCP activities are conducted according to applicable regulatory requirements, MAPS PBC policies and processes, and applicable best practices. The ADQA manages the team supporting all GCP quality assurance and compliance initiatives. This includes the establishment and maintenance of Quality Event (QE) system and associated Corrective Action and Preventive Action (CAPA) system, and the oversight of the Standard Operating Procedure (SOP) system. A major focus of the ADQA role is the management and timely execution of a risk-based audit program for systems, vendors and clinical sites. The ADQA is expected to be collaborative and work with clinical teams to efficiently meet the goals and objectives of the QA organization. It is an expectation that risk-based methodologies are used throughout the Quality Management System.


The ideal individual will be expected to take a measured approach under pressure and exercise good judgment in a variety of situations, have strong written and verbal communication, be highly organized and able to prioritize workload. An important attribute is the ability to motivate colleagues to foster a positive, learning environment where creative risk-based approaches to maintaining regulatory compliance efficiently are developed. The ADQA will support the MAPS PBC Quality System, which will require working with and advising QA staff and Subject Matter Experts (SMEs) on quality and compliance-related issues related to their area of expertise and responsibilities.


Location:
Remote


Hours: Full time, exempt, salaried position. Must be available during normal business hours for a California-based company.

 

Essential Job Functions:

  • Manage the GxP Annual Audit schedule that will include internal, vendor and study-specific audits.
  • Establish and maintain the Quality Event (QE) program and CAPA program.
  • Manage the development and maintenance of GCP SOPs
  • Manage the MAP PBC clinical and vendor audit programs.
  • Manage resources (internal and external) to ensure ongoing execution of all assigned QA tasks, ensuring that required documentation is appropriately completed, reviewed, filed, etc.
  • Compile, manage and present clinical and vendor quality assurance-related metric reports, as required
  • Set, assess and manage the goals and priorities for QA direct reports, mentoring as needed.
  • Advise SMEs on regulatory requirements and GCP compliance 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 Support the development of training material and training delivery for QA and MAPS PBC staff, as needed.
  • Execute other assigned tasks related to regulatory compliance, inspection readiness, and quality systems.
  • Collaborate with cross-functional teams in advancing projects with strict deadlines and multiple stakeholders obtaining buy-in.

Education/Experience:

  • Bachelor’s Degree in a clinical or scientific field.
  • 7+ years’ direct experience in GxP 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 guidelines

Knowledge, Skills and Abilities:

  • Experience managing people and teams to meet shared and individual goals and objectives. Must have exceptional leadership and interpersonal skills; should have proven skills as an effective team player building credibility and confidence within and outside the company.
  • Sound understanding of quality and risk management concepts as they apply within the pharmaceutical industry, for example, use of Key Risk Indicators (KRIs), Key Quality Indicators (KQIs) and Quality Tolerance Limits (QTLs)
  • Proven experience planning and executing risk-based audits of vendors, and clinical investigator sites as well as developing annual audit plans and ensuring that observations are appropriately categorized, communicated and resolved.
  • 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.
  • Excellent writing and process summarizing skills, ability to create and edit flow charts.
  • Strong verbal communication skills; non-confrontational, 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.

Work Environment:
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10 % of work time once Covid restrictions lift.


Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Core Competencies:

  • Problem Solving - Identifies and resolves problems in a timely manner evaluating alternative solutions. Works well in group problem solving situations and uses reason even when dealing with emotional topics.
  • Interpersonal Skills - Focuses on solving conflict. Listens to others without interrupting and keeps emotions under control while remaining open to others' ideas.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations. Listens and gets clarification.
  • Grit - Goal-oriented, purpose-driven and willing to put in the work. Ability to take a challenge and run with it with an open mind constantly finding ways to succeed.
  • Written Communication - Writes clearly and informatively. Varies writing style to meet needs. Able to read and interpret written information.
  • Teamwork - Balances team and individual responsibilities. Exhibits objectivity and openness to others' views. Contributes to building a positive team spirit and puts success of team above own interests.
  • Quality Management - Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
  • Business Acumen - Understands business implications of decisions and aligns work with strategic goals.
  • Cost Consciousness - Works within approved budget and conserves organizational resources.
  • Diversity - Shows respect and sensitivity for cultural differences supporting a diverse workforce. 
  • Ethics - Treats people with respect and keeps commitments. Inspires the trust of others and works with integrity and ethically. Upholds organizational values.
  • Organizational Support - Follows policies and procedures. Completes tasks correctly and on time supporting the organization's goals and values. 
  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Judgment - Displays willingness to make decisions and exhibits sound and accurate judgment. Supports and explains reasoning for decisions. Includes appropriate people in decision-making process and makes timely decisions.
  • Motivation - Sets and achieves challenging goals. Demonstrates persistence and overcomes obstacles. Measures self against standard of excellence taking calculated risks to accomplish goals.
  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Adaptability - Adapts to changes in the work environment and manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events with a high level of comfort with ambiguity.
  • Dependability - Follows instructions and responds to management direction. Takes responsibility for own actions and keeps commitments. Completes tasks on time or notifies appropriate person with an alternate plan.
  • Initiative - Undertakes self-development activities and Seeks increased responsibilities. Asks for and offers help when needed.
  • Innovation - Displays original thinking and creativity meeting challenges with resourcefulness. Generates suggestions for improving work. Develops innovative approaches and ideas.
  • The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.


FLSA Status: Exempt (i.e. not eligible for overtime)


Compensation: Includes a full benefits package.


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  • Location
    Any City, Any State, California
  • Department
    Quality Assurance
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor