Quality Assurance Supervisor

Manage activities of assigned group(s) to ensure optimum team performance and meet business needs and timelines.,Support personnel management activities such as hiring, promotions, training and development, providing regular direction and feedback on performance, and disciplinary actions.,Prepare and deliver annual performance and salary reviews.,Supervise, mentor, and develop a team of QA specialists.,Promote a culture of quality, accountability, continuous improvement, and operational excellence.,Oversee inspection, testing, auditing, and documentation activities related to product or service quality.,Ensure adherence to internal SOPs, industry standards, and applicable regulatory requirements (e.g., ISO, GMP, GDPR).,Review and approve QA documentation, including quality reports, deviations, CAPAs, and inspection records.,Monitor and analyze quality metrics to identify trends, risks, and opportunities for improvement.,Develop, maintain, and enhance efficient work procedures and processes aligned with company standards and quality directives.,Lead the preparation and maintenance of study and QA files for client audits, sponsor site visits, and regulatory inspections; ensure QA audit files are properly retained.,Act as lead host for client site visits and regulatory inspections, managing communications, inquiries, and all audit-related activities.,Develop corrective and preventive actions (CAPAs) in response to client and regulatory findings and coordinate drafting of follow-up correspondence with affected departments and report outcomes to senior management.,Review and approve SOPs, protocols, batch records, reports, and other regulated records (e.g., deviations, change controls, CAPAs) involving technically complex processes to ensure accuracy and compliance.,Lead the execution and scheduling of internal facility inspections to evaluate the effectiveness of site quality systems.,Support the review, negotiation, and maintenance of Customer and Supplier Quality Agreements.,Provide QA support for validation activities, including computer systems, controlled environments, test methods, and manufacturing equipment.,Facilitate, host, and present at Quality Management Review (QMR) meetings.,Participate in and/or lead QA-related projects and cross-functional continuous improvement initiatives.,Ensure timely resolution of non-conformances and effective implementation of corrective and preventive actions.,Maintain accurate and compliant quality records and ensure the team adheres to controlled document processes.,Ensure site compliance with applicable regulations and corporate policies; escalate identified quality or compliance risks to management.,Collaborate closely with Operations, Laboratories, Customer Service, Facilities Product, Compliance, and other functions to ensure quality standards are embedded across workflows.,Lead or support continuous improvement activities to enhance quality operations, efficiency, employee engagement, and service to internal and external customers.,Communicate quality issues, insights, and recommendations effectively to stakeholders.

Extensive experience in a Quality Assurance role, minimum 5 years.,Proven supervisory experience essential.,Qualified Person (QP) qualification is highly desirable.,Experience with assisting or managing QA audits and inspections as well as interfacing with regulatory agencies.,Detailed knowledge of GMP and ISO standards.,Strong technical QMS experience essential.

Bachelor's degree (B.S. /B.A.) or equivalent, preferably in a life science.