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About the position
BostonGene is seeking a Quality Systems Manager 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 partner 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 causes 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 KPIs for evaluation and reporting to Top Management.
- Ensure compliance with regulatory requirements, standards, and BostonGene procedures/policies for all quality systems.
Requirements
- 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 standards, 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.
