Senior Quality Assurance Manager

About the Role

This position is responsible for the site-wide quality management program designed to ensure continuous measurement and improvement in site performance. The role includes implementing global initiatives at the site level to ensure the reproducibility of operations in line with global programs. It involves employing effective tools to support risk mitigation of quality breaks and responding to quality breaks by implementing measures to correct and prevent future occurrences. The position also ensures compliance with applicable laws, guidelines, and regulations governing the site's operations. Success will be measured by improvements in site quality and operational efficiency, meeting or exceeding client expectations and corporate goals.

Responsibilities

• Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement, and compliance with quality and business requirements.
• Provide support for Quality Systems and maintain the appropriate level of customer service.
• Prepare, host, and respond to findings for external audits (e.g., regulatory, ISO/CAP/CLIA, client, etc.).
• Prepare non-conformance reports and monitor reporting performance and trends.
• Problem-solve, identify root causes, and implement/follow up on corrective procedures and preventive actions to ensure timely resolution of issues.
• Perform internal audits as required according to site and global plans.
• Use auditing as a proactive tool for improvement and compliance, challenging existing practices where appropriate.
• Ensure timely completion and follow-up through to closure of CAPA actions.
• Measure and monitor performance against agreed KPIs.
• Collate and share information/data across the site as appropriate through reports and follow up on identified improvement opportunities.
• Actively contribute to the success of the overall QA team and the site.
• Ensure the company and its Quality Management System (QMS) meets relevant regulations and standards (e.g., FDA, QSR, ISO standards, CLIA, CAP, GLP, GDP, EH&S) and other guidelines.
• Oversee supplier/vendor management, ensuring vendors operate in compliance with applicable quality programs and regulatory guidelines.
• Manage QA department and quality activities such as document control, training, calibration, complaints, incoming inspection, nonconformance, deviation, CAPA system, supplier management system, and internal/external audits.
• Support the site EHS program.
• Actively participate in and/or drive EU/Global QMS improvements as required.

Requirements

• Bachelor’s degree in a scientific discipline.
• Minimum of 5 years of related quality assurance experience.
• Experience with ISO 9001 and CAP/CLIA is required.
• Ability to work in an in-vivo laboratory environment.
• Able to make competent decisions based on a review of analytical data.
• Able to write clear, coherent internal business communications/reports and present results.
• Willing and able to work under the pressure of deadlines and find solutions to meet timelines.
• Ability to work across teams by being a flexible team player with strong communication and interpersonal skills.
• Comfortable using computers, including working knowledge of Microsoft Office programs, email, and internet.
• Exceptional organizational and time-management skills; ability to multi-task with a high degree of professionalism and diplomacy.

Preferred Qualifications

• Experience in the life sciences industry.
• Experience in a GLP/GCP regulated environment.
• Experience with EHS programs.

Pay

Salary range is $120,000–140,000.