Global Head of Quality

We need to output HTML fragment with sections: About the role? The posting has POSITION SUMMARY, DUTIES AND RESPONSIBILITIES, QUALIFICATIONS & EDUCATION REQUIREMENTS, KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIREMENTS, CONDITIONS OF EMPLOYMENT, WORKING CONDITIONS AND PHYSICAL EFFORT. Also travel mention. No explicit Pay, Benefits, Schedule. So we should not create those sections. We need headings: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). But we should map to content: "About the role" could be the POSITION SUMMARY. "Responsibilities" for DUTIES AND RESPONSIBILITIES. "Qualifications" for QUALIFICATIONS & EDUCATION REQUIREMENTS. "Skills" for KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIREMENTS. Possibly "Conditions" maybe not needed; but we could include as a short paragraph under maybe "Additional Information". However instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. So we can include sections for About the role, Responsibilities, Qualifications, Skills. Also maybe "Travel" but not a standard heading; we could incorporate into About the role or Responsibilities as a paragraph. We must not repeat job title as heading. No Job ID. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep details, but we can format as paragraphs and lists. We need to use

• for any list of duties/requirements/benefits. So we should convert bullet-like sentences into list items. We need to remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The posting includes "ProSciento is an equal opportunity employer..." That's EEO boilerplate; should be removed. Also "Verification of educational requirements..." maybe conditions of employment; we can keep as part of Conditions? But it's not a standard heading; we could incorporate into a short paragraph under maybe "Additional Information". However instruction: Prefer a few substantive sections over many thin ones. So maybe we combine Conditions of Employment and Working Conditions into a paragraph under "About the role" or as a separate section "Working Conditions". But we have no standard heading for that; we could create a section "Working Conditions" if we have content. The instruction says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It gives examples but not exclusive; we could use other headings if needed? It says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect us to use those headings only. So we should stick to those. If we have content that doesn't fit, we can fold into existing sections. Thus we will have sections: About the role (position summary + travel + working conditions), Responsibilities (duties), Qualifications (education + experience), Skills (knowledge, skills, competencies). Possibly also "Requirements" but we already have Qualifications and Skills; maybe we can combine Qualifications and Requirements into one? But they gave separate examples; we can use Qualifications for education/exp, Skills for knowledge/skills. We must not repeat job title. No markdown. We need to preserve all substantive information: So we need to include details like 20% travel, etc. Let's extract content. POSITION SUMMARY: The Global Head of Quality provides strategic leadership and oversight of ProSciento's global Quality department, 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 20% domestic and international travel is expected, with additional travel required based on business needs. We can put that in About the role paragraph(s). Also include working conditions: 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. (Note travel already mentioned). We'll combine. DUTIES AND RESPONSIBILITIES: list many items. We'll convert each sentence starting with a verb into

  . Need to preserve all details. Let's list them: - 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 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. We need to keep "Supervisory Responsibilities:" as part of list maybe as a heading inside list? But we can just treat as a list item starting with "Supervisory Responsibilities: Provides leadership..." That's fine. Now QUALIFICATIONS & EDUCATION REQUIREMENTS: - 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. Also "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." That's generic; we can include as a paragraph before list. Now KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIREMENTS: We have paragraphs: "Skills, Knowledge, and Abilities:" then list. Let's extract bullet-like items: - 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. We can treat each as list item. Now we need to output HTML fragment only. Structure:

  About the role

  ... (position summary + travel + working conditions)

  Responsibilities

  • ...
  ...

  Qualifications

  ... generic qualifier paragraph

  • ...
  ...

  Skills

  • ...
  ...

  We must not include sections like Pay, Benefits, Schedule. We must not include boilerplate EEO etc. Check for duplicated lines: The posting had some duplicated lines like "Demonstrated experience designing, implementing, and continuously improving Quality Management Systems (QMS) supporting GCP, GLP, GMP (GxP) environments and clinical research operations."