• Works independently to provide leadership and quality oversight of any area of the business responsible for adhering to current Good Manufacturing Practices (cGMPs) including:

• Critical utilities (e.g. WFI, Steam, Automation, equipment, HVAC, etc.)
• Warehouse
• Manufacturing Processes
• Inspection
• Labeling and Packaging
• Batch Record Review
• Batch Disposition
• New Product Introduction and Product Transfer
• External Quality and Laboratories

• ​Responsible for both executing the tactical operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against current Good Manufacturing Practices (cGMPs) to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation.
• Provides guidance to all GMP areas (i.e., Manufacturing, Quality Control, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be proactively shared across QA and the business including the on-going training of junior team members.
• Performs independent technical review of documentation during and post-execution of cGMP activities.
• Signs off/qualifies/trains junior staff on QA/QC Operation/Validation responsibilities.
• Ensures all specifications are met and that applicable requirements are completed and acceptable.
• Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
• Analyzes and reports findings to appropriate departments.
• Works closely with others in the assigned area to recognize opportunities for improvement and drive change using Quality Systems.
• Serves as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and hosts inspections by regulatory agencies or clients. Maintains the approved supplier list.
• Utilizing a wealth of previous experience, provides a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.
• Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet BIFI and regulatory standards.
• Implements continuous improvement efforts as it relates to QA activities.
• Indirectly leads others within the QA/QC/Validation/Warehouse Teams under the leadership of the area head.
• Fosters quality collaboration among the site and QA staff.
• Identifies, classifies, and reports deviations, as appropriate and typically works on complex Major deviations and/or complaints. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
• Authorized to suspend any operation when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue production. Is required to resolve critical issues utilizing independent judgement and decision making as a senior level of the department. May serve as the final decision-maker in situations requiring the input of others to make a final compliance determination.
• May also be required to communicate with clients, external vendors, external services to resolve investigations as warranted to ensure compliance with regulations and local procedures.
• Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. Sought after by junior team members for guidance in the quality oversight of changes within the Quality Management System including appropriate stakeholders’ reviews are completed such as Regulatory, Client, Area Managers, etc.
• Models effective and constructive communication behaviors and interactions with technical departments, junior team members and senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g., interpersonal) skills.
• Is proficient in technical and non-technical (e.g., interpersonal) skills to ensure the continued success of the department and quality of oversight provided to the business.
• Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations.
• Mentors, trains and coaches new personnel as required and supports the development and implementation of training programs. Available to act as a resource for colleagues with less experience regardless of level.
• Support regulatory documentation generation and submissions for new products developed at BioTechnique.
• May work on external client projects as a consultant, as needed.
• Other duties as required.