Manager, GxP Quality Assurance

Position Summary

MAPS PBC is seeking a quality assurance professional to execute 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, including document control, training, vendor qualification, internal GxP and clinical site auditing. The QAM will be expected to take a hand 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 in way that supports 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.

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.

Minimum Requirements

• 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.
• Experience managing people and teams to meet shared and individual goals and objectives
• Solid understanding of basic quality management concepts as well as how they apply within the pharmaceutical industry
• Proven experience in SOP development and document management operations
• Knowledge of global GxP regulatory requirements, guidance, and industry standard practices
• Proven GxP auditing experience, including investigator site auditing
• Inspection readiness or facilitation experience desired
• 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 understand and execute risk-based approaches that improve efficiency
• Recognize potential obstacles and manage a team to work within set timelines, conscientious and precise delivery of work even when under pressure

Position Duties

• The QM performs the following duties: 
• Manage the GxP Document Lifecyle process and the coordinating role-based training process
• Manager team to ensure ongoing execution of all assigned QA processes, ensuring that required documentation is appropriately completed, reviewed, filed, etc.
• Manage the GxP Vendor Qualification and Management process including conducting vendor qualification and ongoing audits
• Manage the MAPS CAPA Management System/Process
• Prepare Quality Systems-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
• Support the goals and directives of Quality Assurance and Compliance Leadership through execution of ongoing and new GxP QA activities
• Participates in and supports the development of training material/learning solutions and training for QA and MAPS PBC staff, as needed
• Execute other assigned tasks related to regulatory compliance, inspection readiness, and quality systems

Additional Competencies

• 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  

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

Compensation: Salary range disclosed upon request. Includes full benefits package.