BostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations.
Responsibilities
? Ensure all activities are conducted in compliance with BostonGene's Quality Management System (QMS), appropriate regulations, and international and national regulations, and are aligned with regulatory agency expectations.
? Serve as the site head for all laboratory inspections and audits. In collaboration with Clinical QA, serve as the site head for all FDA, Notified Body, or pharma partners audits and inspections.
? Initiate and drive investigation, deviation, and CAPA meetings and on time closures.
? Review and approve investigations, deviations, and CAPAs providing feedback for content improvement. Perform investigations and deviations as needed, and assign CAPAs to relevant personnel and ensure completion within required timeframes.
? Determine root cause of nonconforming events and appropriate corrective and preventative actions.
? Assist with other Quality System documentation as needed.
? Track and trend events to identify issues. Lead meetings to discuss any identified trends and assist with remediation activities.
? Develop strong relationships with Operations, Product, and Lab personnel.
? Develop and execute plans related to QMS improvements.
? Lead and document management review meetings. Oversee metrics and KPI' s for evaluation and reporting to Top Management.
? Ensure compliance with regulatory requirements, standards, and BostonGene procedures/policies for all quality systems which include document control, organizational and personnel, change management, corrective and preventive actions, nonconformances, deviation management, audit program, etc.
? Other duties as assigned.
Qualifications
? BS Degree in the Sciences or other technical discipline, or 5+ years of QA experience in the medical device or diagnostic industry, or the equivalent combination of education, experience and/or training.
? Minimum of 3 years directly managing a QA and/or Quality System department.
? Strong regulatory compliance knowledge including ISO and QSR. CLIA/ CAP is a plus.
? Experience with managing QA activities across multiple quality system requirements (e.g., operating under both ISO 9001, ISO 13485, ISO 14971 standard and FDA part 820 regulations).
? Skilled at performing and leading internal and external audits.
? Proven track record leading and executing process improvements.
? Strong communication and presentation skills.
? Demonstrate ability to apply Root Cause Analysis tools and structured problem-solving methodologies to QMS issues.
? Effective organizational and time management and the ability to work towards multiple priorities while delivering quality outcomes.
? Certified Quality Auditor and/or Certified Quality Manager through ASQ is a plus.