1.Purpose of the Job

The Director Site Compliance is responsible for the site senior leadership oversight of key compliance and quality governance and improvement initiatives across St. Louis site. The incumbent, along with the Site General Manager and the Site Quality Head, will be responsible to ensure site compliance with cGMP requirements and PSG Global Quality policies and procedures.

This role will own the senior leadership oversight of strategy, identification and execution compliance and quality improvement initiatives ensuring representation in site leadership meetings and site strategic meetings.

The Directo Site Compliance, role will report to the Sr. Director Quality, Biologics Business Unit, be part of the St. Louis Site Leadership Team and report indirectly to the site General Manager in St. Louis.

2.Job Content

• Senior leader representative of site key compliance and quality improvement initiatives
• Ensure proper resource and budget allocation to site key quality improvement initiatives in conjunction with Site Quality Head and Site General Manager
• Ensure proper governance of key quality and compliance improvement initiatives which includes participation from site and above site senior leaders. Be part of and ensure proper escalation pathway.
• Actively participate in the site quality governance and ensure proactive identification of trends as well as timely definition of corrective and preventive actions
• Foster and role model site quality culture
• Responsible for mentoring and coaching the organization on quality and compliance to the cGMP regulations.
• Host the quality council and Quality Management Review in collaboration with Quality Unit