Global Head of Quality

POSITION SUMMARY

The Global Head of Quality provides strategic leadership and oversight of ProSciento's global Quality department, [MM1] establishing the strategy, direction, governance, and priorities for the function. This role will oversee the Quality Management System (QMS) and ensures the organization maintains the highest standards of quality, regulatory compliance, and inspection readiness.

This role is accountable for establishing and advancing the company's quality strategy, Quality by Design and governance framework, and quality culture while ensuring compliance with applicable GxP regulations, FDA requirements, ISO standards, and other country specific, regional, and international regulatory requirements. The Global Head of Quality partners closely with executive leadership and cross-functional teams to drive continuous improvement, operational excellence, risk management, and organizational effectiveness while supporting ProSciento's strategic growth. Performs duties in accordance with ProSciento's values, policies, and procedures.

Approximately [MM2] 20% domestic and international travel is expected, with additional travel required based on business needs.

DUTIES AND RESPONSIBILITIES

• ✓Provides strategic leadership for ProSciento’s Quality department, establishing the vision, priorities, and organizational structure to support the company’s operations and business objectives.
• ✓Accountable for the design, implementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with all applicable regulations including GCP, GLP, GMP (GxP), FDA, ISO, data privacy requirements, and other local, national, and international requirements.
• ✓Responsible to oversee the quality of Global CRO studies and local site CRU trials as well as hands on experience implementing and maintaining a strategic Quality by Design framework for both business units.
• ✓Responsible for the definition, development, implementation, monitoring and continuous improvement of quality systems, processes, and Key Quality indicators (KQIs) to drive operational excellence[MM3] and regulatory compliance.
• ✓Oversees the Quality Event Management program, including deviations, CAPAs, change control, investigations, risk assessments, and process improvement initiatives. Chairs or delegates the CAPA Board and ensures timely resolution of quality issues.
• ✓Directs internal, external, sponsor, vendor, and regulatory inspection readiness activities, including audit planning, execution, response management, and corrective action oversight.
• ✓Partners with Vendor Management to oversee supplier qualification, vendor audits, performance monitoring, and quality risk mitigation.
• ✓Leads Executive Quality Management Reviews, ensuring quality trends, compliance risks, audit outcomes, CAPAs, and quality metrics are routinely communicated to Executive Leadership with appropriate recommendations and mitigation strategies.
• ✓Oversee the development, maintenance, and governance of Quality Management System documentation, including quality policies, SOPs, work instructions, controlled documents, training programs, equipment records, and electronic document management systems.
• ✓Partners with Information Technology and business leaders to ensure computerized systems, electronic records, and applicable equipment are appropriately qualified, verified, or validated in accordance with regulatory requirements and industry best practices.
• ✓Establishes and promotes a culture of quality throughout the organization by providing strategic guidance, regulatory interpretation, and quality leadership across all functional departments.
• ✓Maintains current knowledge of evolving global regulatory requirements, industry standards, and best practices, ensuring organizational policies and procedures remain compliant and effective.
• ✓Builds, develops, and leads a high-performing Quality organization by fostering employee development, succession planning, collaboration, accountability, and a culture aligned with ProSciento's core values.
• ✓Serves as the senior quality representative for regulatory agencies, sponsors, auditors, and executive leadership on matters relating to quality systems, compliance, and inspection readiness.

Supervisory Responsibilities

• ✓Provides leadership and oversight for the Quality organization, including workforce planning, organizational design, recruitment, employee development, performance management, succession planning, coaching, and employee engagement.
• ✓Establishes departmental objectives, allocates resources, and ensures the Quality organization effectively supports ProSciento's strategic and operational priorities.

QUALIFICATIONS & EDUCATION REQUIREMENTS

Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• ✓Bachelor's degree in Life Sciences or a related field required; advanced degree preferred.
• ✓Minimum of 10 years of progressive experience in Quality Assurance, Quality Systems, or Regulatory Compliance within the CRO or clinical research industry, including at least 5 years in senior quality leadership roles with responsibility for organizational quality strategy and personnel management with a minimum of 3 years of Global experience.
• ✓Equivalent combinations of education, training, and relevant experience will be considered.

KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIREMENTS

Skills, Knowledge, and Abilities

• ✓Extensive knowledge of Quality Management Systems and quality governance, with demonstrated experience designing, implementing, and continuously improving quality systems within clinical research and regulated environments.
• ✓Comprehensive knowledge of applicable global regulatory requirements and industry standards, including FDA regulations, ICH Guidelines, GCP, GLP, GMP (GxP), ISO 9001, data integrity, and applicable privacy requirements. Demonstrated experience designing, implementing, and continuously improving Quality Management Systems (QMS) supporting GCP, GLP, GMP (GxP) environments and clinical research operations.
• ✓Demonstrated experience leading regulatory inspections, sponsor and internal audits, supplier qualification programs, CAPA governance, inspection readiness, and enterprise quality risk management.
• ✓Demonstrated ability to build, lead, and develop high-performing quality organizations, while fostering a culture of accountability, collaboration, and continuous improvement.
• ✓Proven strategic leadership, organizational planning, and change management skills, with the ability to partner with executive leadership and cross-functional stakeholders to establish quality strategies and organizational priorities.
• ✓Excellent analytical, problem-solving, and risk assessment capabilities.
• ✓Strong communication and executive presentation skills with the ability to influence stakeholders across all organizational levels.
• ✓Experience leading regulatory inspections, sponsor interactions, and quality governance forums.
• ✓Ability to balance strategic leadership with operational execution in a dynamic, fast-paced organization.
• ✓Proficiency with electronic Quality Management Systems (eQMS), document management systems, quality metrics, and computerized system validation principles.

Language Skills

Excellent verbal and written communication skills, including the ability to interpret complex regulations, prepare executive reports, develop policies and procedures, and effectively communicate with regulatory agencies, sponsors, auditors, executive leadership, and employees.

Reasoning Skills

Ability to analyze complex regulatory and operational issues, exercise sound judgment, assess organizational risk, and develop practical, compliant solutions in a dynamic business environment.

Computer Skills

Advanced proficiency with Microsoft Office Suite and experience with electronic Quality Management Systems (eQMS), document management systems, learning management systems, audit management tools, and computerized system validation principles. Ability to quickly learn new software applications.

CONDITIONS OF EMPLOYMENT

Verification of educational requirements, employment history, professional references, and certifications/training and U.S. work authorization.

WORKING CONDITIONS AND PHYSICAL EFFORT

• ✓Work is primarily performed in a professional office environment and may be conducted onsite, remotely, or in a hybrid work arrangement based on business needs and management approval.
• ✓Occasional domestic and international travel may be required to support audits, regulatory inspections, client meetings, and business operations.

The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.

ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.