A$ A' "A' ?POSITION SUMMARY:The Manager, Quality Assurance (QA) will provide general supervision and technical guidance to the QA Lot release, QA Compliance and Document Control Staff members; provide leadership developing and directing QA and Document Control quality improvement initiatives for all company products and services, and monitor QMS systems and advise the senior leadership team on system performance. The Manager, QA is responsible for ensuring that programs such as the Lot Release Program, Investigation Management and CAPA Program, Supplier Qualification Program, Internal and External Auditing Program, Training Program and the Quality Metrics and Trending Program are effective and in compliance with relevant US and international regulatory requirements, company polices and procedures. In addition, the Manager, QA will lead the Quality Assurance department's effort to ensure continuous improvement by implementing process controls. The Manager, QA has the responsibility for training, mentoring, and supervising QA Staff and as applicable, performing batch record review and lot release activities. The Manager, QA will also lead the preparation for, and as required, host external audits of IDT Biologika Corporation. ESSENTIAL DUTIES AND RESPONSIBILITIES: Collaborate with client-facing QA representatives to ensure full customer satisfaction with the company's products and services.Provide guidance to Document Control group to support a controlled document management system. Promote and advocate quality achievement and performance improvement across the organization.Identify relevant QA training needs and opportunities.Provide Quality System training to employees.Lead the preparation for, host or co-host and respond to external GMP audits of IDT Biologika Corporation.Manage the QA Lot Release Group and coordinate QA Specialist schedules to align with manufacturing and testing schedules.Manage the Quality Event (QE) Investigation Program and coordinate QA Specialist within the QA Lot Release Group to ensure deviations and OOS investigations are appropriately investigated and communicated to the Clients.Ensure that the Supplier Qualification program is effective and complies with the FDA and other applicable regulations and Quality Standards. Maintain an efficient Internal Auditing Program that regularly evaluates internal groups for regulatory compliance. Evaluate audit responses, ensuring adequacy, root cause, timeliness and facilitate corrective action. Document and report audit observations to Quality Management and vendors in a timely manner and ensure timely audit closure.Employ compliance metrics to identify non-compliant operational trends and make quality improvement recommendations to management.Assist management with implementing compliance and mentoring programs within Quality Assurance. Participate in site Regulatory Inspections as needed. Perform Batch Record Review, Lot Disposition, and issuance of Certificate of Analysis and Certificate of Compliance.Perform other duties as assigned.SUPERVISORY RESPONSIBILITIES: Manage the daily activities of QA Staff, including mentoring, performance evaluations, setting goals and assisting in career development. Monitor, conduct and adjust audit schedules in a flexible manner that maintains a proper balance of work activities along with speed and efficiency to meet imposed timelines.Ensure QA staff interfaces with Technical Operations to close corrective and preventive actions for audit reports, deviations and investigations in a reasonable timely manner and according to defined timelines.Communicate and interact with management and client's team members to assure compliance and required documentations are provided. Be able to review reports and recognize and communicate regulatory noncompliance along with providing recommendations for corrective and preventive actions. Ensure delivery against QA department goals and objectives, ie, meeting commitments and coordinating overall Quality Assurance task. Manage Quality Management System metrics for performance improvements. QUALIFICATIONS AND REQUIREMENTS: Bachelor of Science in a scientific discipline. Minimum 8+ years of experience in a QA role (GMP) in a life science company with exposure to vaccines and different phases of clinical trials. Advance knowledge of 21 CFR Part 210, 210, 600, 610 and 21CFR Part 11.Good understanding of EU EMA compliance requirements.Demonstrated experience in developing and implementing Supplier and Internal Auditing and Investigation Management Programs.Demonstrated experience with Batch Record Review and Batch Disposition of vaccines or other biological products.Proven ability to identify CAPA and close non-compliance.Strong experience leading GMP audits (Internal/External).Hands-on validation experience (process or equipment). Experience and understanding of international GMP regulations.Must be able to talk operations and compliance and be able to lead in the field.Must be independent decision maker and be able to demonstrate strong leadership skills. Conflict management experience is required. Must be able to travel up to 20%. Proven ability to exercise good judgment and effectively balance work and changing priorities.Able to supervise and mentor direct reports and perform performance evaluations, goal setting and feedback on direct reports. Detail-oriented with strong verbal and written communications skills; demonstrated ability to manage multiple projects/tasks; as well as effective presentation skillsProficient in Microsoft Office IDT offers a competitive compensation package to include major medical/dental/vision, group life insurance, STD/LTD plans, 401k plan with company match, and paid vacation, sick and holidays. IDT Biologika Corporation is an Equal Opportunity Employer: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.