Quality Assurance Supervisor

Manage assigned group(s) to ensure optimum team performance and meet business needs and timelines.,Support personnel management activities including hiring, promotions, training, development, and providing regular performance feedback 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.,Lead the preparation and maintenance of study and QA files for client audits, sponsor site visits, and regulatory inspections.,Act as lead host for client site visits and regulatory inspections.,Develop corrective and preventive actions (CAPAs) and coordinate follow-up correspondence.,Review and approve SOPs, protocols, batch records, reports, and other regulated records.,Lead the execution and scheduling of internal facility inspections.,Support the review, negotiation, and maintenance of Customer and Supplier Quality Agreements.,Provide QA support for validation activities.,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.,Ensure site compliance with applicable regulations and corporate policies.,Collaborate closely with various departments to embed quality standards.,Communicate quality issues, insights, and recommendations effectively.

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