A Quality Assurance Manager focuses on prevention of mistakes and defects in manufacturing products. Develops procedures to ensure that quality standards are maintained. Manages all steps related to quality assurance as part of the quality management strategy of a company. May involve leadership of a team of quality assurance supervisors, specialists, and other associated staff members.
The Senior Manager, Quality Management Systems (QMS) will support the ongoing effectiveness, maturity, and inspection readiness of the Quality Management System, with a primary focus on Quality Events, training, and continuous improvement. This role will provide leadership, coaching, and subject matter expertise to ensure Quality processes are consistently understood and effectively executed across the organization.
Responsibilities:
Lead training, coaching, and ongoing guidance for team members on Quality Events, QMS processes, systems, and associated regulatory expectations. Support continuous improvement of QMS procedures, processes, tools, and training materials to enhance clarity, consistency, compliance, and operational effectiveness. Provide subject matter expertise and backup review and approval for Quality Events, including deviations and other assigned records. Support product complaint and temperature excursion investigations, ensuring appropriate investigation, documentation, escalation, and timely resolution. Provide oversight and guidance for CAPA development, implementation, and effectiveness assessments to ensure actions appropriately address identified risks and root causes. Drive ongoing audit and inspection readiness for Quality Events by promoting complete, accurate, timely, and inspection-ready documentation. Support Quality Event governance, metrics, trending, and identification of systemic issues and opportunities for improvement. Partner cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Safety, and other stakeholders to resolve quality issues and strengthen QMS execution. Promote a strong quality culture through practical guidance, proactive problem solving, and continuous improvement.
Required Skills, Experience and Education:
Bachelor's degree in a scientific, technical, engineering, pharmacy, or related discipline; equivalent relevant experience may be considered. Minimum of 10 years of pharmaceutical or biotechnology Quality Assurance or Quality Systems experience. Strong experience with Quality Events, including deviations, investigations, CAPAs, effectiveness checks, product complaints, and temperature excursions. Demonstrated ability to train and coach team members on Quality Event processes, systems, investigation practices, and documentation expectations. Experience supporting QMS procedures, process improvements, and associated training materials. Strong knowledge of GMP requirements, Quality Risk Management, data integrity, and inspection-readiness expectations. Experience with eQMS workflows, audits and inspections, Quality metrics, and continuous improvement. Strong communication, collaboration, and influencing skills with the ability to work independently and effectively across functions.
Preferred Skills:
Advanced degree or relevant professional Quality certification preferred. Experience with Veeva Quality Vault or a comparable eQMS. Commercial-stage pharmaceutical or biotechnology experience. Experience in small-molecule pharmaceuticals, oncology, or a growing organization preferred.
