Director Business Process Excellence (Remote)

THE POSITION:

DIRECTOR, Business Process Excellence is expected to effectively manage teams, ensure compliance, drive project delivery, and communicate with clients and stakeholders while overseeing the safety of pharmaceutical products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

Business Process Excellence (BPE)

1. Business Process Excellence

Perform continuous monitoring and enable the quality deliverables from the project on time meeting the minimum quality standards

Drive all the quality deliverables of the project meeting the governing procedures timelines

Perform periodic quality and compliance activities, including process-level checks, periodic gap assessments and audit readiness, and document reviews.

Lead business process excellence resources assigned to projects and ensure adherence to quality standards which should be agreed and aligned with the customers for each project.

Review the QNCR before submitting to QA ensuring adequate level of investigation and root cause assessment and CAPA actions.

Review and submit the evidences of CAPA evidence to QA for timely closure of the records in the QMS.

2.Audit and Inspection Readiness, CAPA management and tracking, Inspection handling

Ensure projects are prepared for audits and inspections through periodic reviews and readiness assessments.

Periodically identify areas that need constant monitoring (including points that emerged from previous CAPA actions, client escalations) from an inspection readiness point of view & ensure that operations teams present the same for review during compliance meetings.

Implement check measures to periodically ensure that compliance with global regulations and guidelines (e.g., GxP) is met at all times.

Review the CAPA response (prepared by operations) to audit/inspection observations

Submission of available evidence to close the CAPA in the QMS.

3 Risk Mitigation

Periodically identify and highlight risks to compliance, maintain a risk register and track the resolution of the identified risks

Track updating of the process documents (SOPs/Wis) as per timeline and requirements of the regulatory update as per the Regulatory Intelligence process

Track and ensure any vendor/third party services used for the project are done as per the contractual obligations and compliance to the governing process documents.

Review any project-specific documents like transition document, project management plans, Special project Plans etc.

4 Training and Development

Review and update role-based training curriculums, job descriptions are aligned with project processes.

Ensure team members complete required GxP training and are qualified to perform activities.

Review training records and JD and CV for its adequacy.

5 Continuous Improvement and Client Engagement

Monitor and present quality and compliance metrics during client governance meetings.

Provide periodic updates to clients on quality metrics and lead continuous improvement initiatives.

Identify and address process gaps to align with evolving client requirements and project scope

Ensure timeline as per the client expectations on communicating the relevant quality deliverables

Track all the open items from the governance meetings are addressed timely and communicated to client and evidences are stored.

Ensure MOMs are present for all the governance meetings on timely manner

6 Leadership and Team Management

Lead and mentor business process excellence to optimize performance.

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

7 Process and Contract Alignment

Review customer service agreements and contracts and recommend process updates to reflect changes in scope or requirements. Ensure all processes and documentation align with quality requirements.

8 Due diligence

Conduct client-based due diligence of proposed acquisitions

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.