Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management in the United States.

This senior leadership role is responsible for overseeing global Quality Management System (QMS) processes focused on escalated GxP and quality incidents, ensuring robust risk management, compliance, and continuous improvement across regulated operations. The position plays a critical role in safeguarding product quality, patient safety, and regulatory adherence by driving end-to-end management of complex quality events. It combines strategic leadership with hands-on expertise in incident management, root cause analysis, and CAPA execution across a global footprint. The role also serves as a key authority in Quality Risk Management frameworks, ensuring alignment with international regulations and industry standards. In addition, it leads the development of knowledge management capabilities that enable faster access to critical quality and product data across the lifecycle. Operating in a highly cross-functional and regulated environment, this role requires strong collaboration with R&D, manufacturing, regulatory, and patient safety teams. It is an opportunity for a quality leader to shape enterprise-wide standards and strengthen a culture of compliance and continuous improvement.

• Lead and continuously improve global GxP and quality incident management processes, ensuring alignment with regulatory expectations and enterprise quality objectives.
• Oversee end-to-end management of escalated quality events, including intake, triage, investigation, documentation, resolution, and closure of incidents across global operations.
• Drive root cause analysis and CAPA development, ensuring effective corrective and preventive actions and the implementation of lessons learned across the organization.
• Act as a key SME for Quality Risk Management frameworks (e.g., ICH Q9), facilitating risk assessments, complex investigations, and change control processes.
• Ensure regulatory compliance with global authorities (FDA, EMA, ISO, WHO and local agencies), including preparation and support for audits and inspections.
• Collaborate closely with cross-functional teams including manufacturing, QA/QC, regulatory affairs, clinical operations, development, and patient safety to ensure timely resolution of quality issues.
• Develop and deliver training, metrics, and reporting systems to strengthen quality culture, improve performance visibility, and support continuous improvement.
• Build and enhance knowledge management systems and tools in collaboration with data and product quality teams to enable enterprise-wide access to critical information.

• Bachelor’s degree in Life Sciences, Quality, Engineering, or a related discipline with 8+ years of experience in quality systems or regulated environments; Master’s degree with 10+ years preferred.
• Significant leadership experience (6+ years) managing teams, programs, or large-scale quality operations in pharmaceutical, biotech, or medical device industries.
• Strong expertise in GxP compliance, quality systems, incident management, CAPA processes, and regulatory frameworks.
• Proven experience with global regulatory interactions and communications with health authorities on complex compliance matters.
• Deep understanding of Quality Risk Management principles (ICH Q9) and structured problem-solving methodologies.
• Strong analytical skills with the ability to lead root cause investigations and drive data-driven decision-making.
• Experience with enterprise systems and tools such as Veeva, SAP, Power BI, or similar platforms, with strong MS Office proficiency.
• Excellent communication, stakeholder management, and cross-functional leadership skills in global matrix organizations.
• Ability to influence, drive accountability, and foster a strong culture of quality, compliance, and continuous improvement.
• Willingness to travel up to 20% as required.

• Annual base salary range: $172,000 – $232,000 USD, depending on experience and location.
• Eligibility for annual bonus programs and/or incentive compensation plans.
• Discretionary equity awards and Employee Stock Purchase Plan participation opportunities.
• Comprehensive health coverage including medical, dental, and vision insurance.
• Retirement savings plan (401(k)) and financial wellness programs.
• Flexible spending accounts (FSA/HSA) for healthcare-related expenses.
• Life insurance and wellness support programs.
• Generous paid time off and holiday policies supporting work-life balance.
• Inclusive, global work environment focused on continuous learning and professional growth.