EVERSANA - Director - Business Process Excellence (10-13 yrs)

- We are seeking a seasoned professional to lead and manage Business Process Excellence (BPE) initiatives.

- The role involves overseeing compliance, ensuring project quality, managing risks, and fostering continuous improvement while maintaining strong client and stakeholder engagement.

Roles and Responsibilities:

Business Process Excellence:

- Monitor and ensure timely delivery of quality project outcomes in compliance with procedures and standards.

- Conduct periodic quality and compliance reviews, including gap assessments and audit readiness activities.

- Lead BPE resources assigned to projects, ensuring alignment with customer-agreed quality standards.

- Oversee root cause analysis, CAPA actions, and submission of evidence for timely closure in QMS.

Audit and Inspection Readiness:

- Ensure projects are prepared for audits/inspections through periodic readiness reviews.

- Identify and monitor areas requiring attention for compliance with global regulations like GxP.

- Review CAPA responses and ensure evidence submission for timely closure in QMS.

Risk Mitigation:

- Maintain a risk register and track resolution of compliance risks.

- Ensure timely updates to process documents based on regulatory changes.

- Monitor vendor/third-party services for compliance with contractual and process obligations.

Training and Development:

- Update training curriculums and ensure team members are qualified for their roles.

- Review training records, job descriptions, and CVs for adequacy and alignment with project needs.

Continuous Improvement and Client Engagement:

- Present quality and compliance metrics during client governance meetings.

- Lead process improvement initiatives to align with client requirements.

- Ensure timely communication of quality deliverables and track resolution of governance meeting action items.

Leadership and Team Management:

- Mentor and lead the BPE team to optimize performance.

- Collaborate with internal teams and external stakeholders to support safety and compliance.

Process and Contract Alignment:

- Review service agreements and recommend updates to reflect scope or requirement changes.

- Ensure processes and documentation align with quality requirements.

Due Diligence:

- Conduct client-based due diligence for proposed acquisitions.

Skills and Qualifications:

- Proven expertise in business process excellence and compliance.

- Strong knowledge of quality management systems, GxP regulations, and CAPA management.

- Experience in audit and inspection readiness and handling.

- Excellent leadership and cross-functional collaboration skills.

- Strong communication and client engagement abilities.

- Analytical mindset with a focus on continuous improvement