Supervisor Quality Compliance (Onsite)
Colorado StaffingFort Collins, CO, US18 hours ago
Job type
- Full-time
Job descriptionDevelop 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, and the support team to facilitate an audit is defined, and SOPs are established in alignment with applicable global regulations and industry trends for Quality Audits to ensure a robust auditing program is established and maintained. Work directly with affiliates and distributors to ensure that regulatory inspections are managed in accordance with applicable guidelines and responses are submitted in accordance with regulatory requirements. Facilitate the QMR process to monitor and provide oversight of Tolmar's quality systems performance. Ensure that phase-appropriate systems are implemented to sustain a consistent level of quality and compliance in all processes. Maintain compliance with industry standards and regulatory requirements (e.g., ISO 9001, FDA regulations). Responsible and accountable for the Quality Review Board and Quality Management Review program which includes maintaining compliance with the regulation requirements, maintaining meeting charters, owning the process / procedures that govern the meetings, reviewing the presentations prior to the meetings and ensuring the quality board meetings are being held per the process / procedure requirements. Manage and compile Quality site metrics and ensure data is presented at the Quality Management Review (QMR) meeting. Develop, implement and approve Quality Compliance policies and procedures. Responsible for ensuring a compliant and efficient Field Alert / regulatory notification quality system, ensuring that Field Alerts / regulatory notifications are reported within the required timeframes. Responsible for ensuring a compliant system is established for recalls, including leadership of mock recalls. Ensure communication of the recall is completed with stakeholders and regulatory agencies per the established recall plan. Develop and maintain Key Performance Indicators for Internal Auditing, Inspection Readiness and any other related KPI, as necessary, and report through QMR meetings as required or any other management governance meetings. Ensure that all quality-related documentation is accurate, up-to-date, and maintained within a system like a QMS. Investigate compliance violations, perform root cause analysis, and implement corrective and preventive actions (CAPA). Deliver Quality support to Affiliate partners to drive a standardized approach to ensuring compliance with relevant GMP and GDP regulations. Notify senior leadership of potential negative trends or high compliance risk items that may impact the business and / or compliance profile for the company. Perform risk assessments and developing strategies to manage potential compliance issues. Assess quality systems to address changing Regulations or industry standards, providing regulatory interpretation and guidance where required. Compile pertinent QA metrics for Senior Leadership review; assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Leadership on a periodic basis. Manage the Annual Product Quality Review (APQR) process to ensure product quality and regulatory compliance, which includes reviewing product quality metrics, managing related corrective actions, and reporting findings to management. Be responsible for the entire APQR process, including approval of the APQR schedule management from new product introductions through discontinuations, analyzing product quality metrics, and identifying trends. Invest time in professional development.
Supervisor Quality Compliance
Core Hours : Monday - Friday, 8am-5pm
Purpose and Scope : 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.
Essential Duties & Responsibilities :
General :
- 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.
Inspection Readiness and Inspection / Audit Management :
Quality Compliance :
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Quality Supervisor • Fort Collins, CO, US
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