Supervisor Quality Compliance

The Supervisor Quality Compliance is responsible for management and oversight of the Quality Compliance team within the Quality Assurance Unit to ensure the company's adherence to industry regulations, quality standards, and internal policies. This role involves managing compliance-related documentation, analyzing quality metrics to identify areas for improvement, and acting as a liaison with business partners and regulatory agencies.

The areas of oversight within this role include Internal Auditing, Inspection Readiness, Regulatory Audits/Inspections, Quality Management Review (QMR) and Quality Review Board (QRB) programs, Annual Product Quality Reports, Field Alert/regulatory notification reporting and the Recall program.

• Maintain a culture of candid communication and continuous improvement with a hybrid/remote team.
• Provide coaching and identify education opportunities for team members to stay current on industry standards and trends
• Participate in all regulatory, third party and customer audits and inspections, and corrective action responses.
• Be an active participant on cross-functional teams, representing the Quality Systems & Compliance department.
  
  Support the Manager Quality Compliance in Field Alert reporting or any recall activities, as applicable.
• Drive collaborative cross-functional interactions with local and global quality personnel to identify and implement process improvements.
• Lead standardization of Standard Operating Procedures, leveraging existing Quality Systems within the functional area.
• Interface and support inspections with Regulatory agencies as required representing the company to authorities and regulatory inspectorates.
• Work collaboratively with both internal and external clients and with regulatory agencies to resolve quality issues and maintain GXP compliance.
• Perform other duties as required.

• Develop and oversee Audit/Inspection Training for SMEs and audit/inspection participants.
• Drive a culture of inspection readiness within Tolmar and ensure periodic walk-throughs of the manufacturing and support areas occur.
• Own the Audit Management system in the Electronic Quality Management System and Inspection software.
• Manage the GxP inspection readiness program, facilitate the Inspection Readiness Steering Committee meetings, ensure the company is prepared for inspections and audits, and manage the Inspection Readiness budget.
• Manage inspections and audits from regulatory authorities and marketing partners and provide follow-up responses for all aspects of the business.
• Participate as a “Front-Room or Back-Room Manager” when applicable, and Subject Matter Expert to ensure accurate, timely production of documents provided to support regulatory inspections.
• Maintain accurate and up-to-date records of quality-related activities, including audits, inspections, and CAPA investigations.
• Conduct internal audits to ensure compliance with quality procedures and identify areas for improvement.
• Manage inspection/audit observations and implement CAPA processes to address quality issues and prevent recurrence.
• Manage the internal audit assessment and approval system, including the establishment of the scheduled audits each year based on risk and budgetary guidelines for internal audits.
• Support planning and execution of Internal Quality compliance audits
• Own and manage the preparation and submission of prepared audit reports and inspection responses detailing deficiencies found during audits and provide follow-up assessments to CAPA actions taken.
• Serve as a primary point of contact for regulatory agencies, managing responses to inspections, and staying current on changes to regulations.
• Develop and deliver training programs to employees on compliance requirements and foster a culture of quality awareness and inspection readiness.
• Perform risk assessments and develop strategies to manage potential compliance issues.
• Investigate compliance violations, performing root cause analysis, and implementing corrective and preventive actions (CAPA).
• Ensure that audit responses are timely and compliant, the support team to facilitate an audit is defined,…