Director Site Compliance

Job Description

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.

• 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

• Experienced leader in operations and quality including leadership of large operational or quality organizations
• Strong experience working on GMP clinical and commercial operations as well a GMP guidelines including but not limited to FDA and EMA
• Experience on management of Health Authority Inspection
• > 10 years' experience of leadership roles in operations and quality
• Sound knowledge on GMP operations and quality in biotechnology drug substance or similar (Cell and Gene Therapy / Aseptic)
• English proficiency, both in oral and written communication;
• Social and communication skills;
• Leadership and coaching skills;
• Pro-active attitude;
• Planning and organizational skills.
• Demonstrated ability to lead through influence
• Minimum of Bachelor's degree in Biology, Chemistry, Engineering or related field.
• Certifications such as ASQ preferred