Senior Manager, QMS Programs

• Identify, champion, and drive cross-functional improvement initiatives to enhance and streamline quality systems, frameworks, and associated processes
• Facilitate stakeholder engagement to ensure quality systems are continuously monitored and improved to strengthen compliance and operational efficiency
• Plan, coordinate, and participate in internal audit activities, including preparation, execution, response coordination, and follow-up of observations
• Coordinate partner audit activities, including preparing, hosting, coordinating response development, and overseeing commitments and CAPAs
• Coordinate and support regulatory health authority inspection readiness efforts (e.g., GMP, GDP), including logistics planning and inspection hosting support
• Develop, review, and approve a variety of controlled documents in alignment with regulatory requirements, relevant guidance, and company standards
• Facilitate quality management reviews and support the development of registers, KPIs, metrics, and dashboards as well as mechanisms for routine reporting
• Apply project management and execution methodologies to prioritize, plan, and deliver quality system and compliance initiatives in collaboration with stakeholders
• Monitor evolving regulatory requirements and guidance, and partner with stakeholders to assess and address potential impacts to the quality system
• Foster a culture of quality, collaboration, and accountability within the team and across the organization
• Perform additional duties as requested

• Bachelor’s degree in life sciences, pharmacy, chemistry, or related field
• 8+ years of experience in the regulated pharmaceutical and/or biotechnology industry, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility
• Full knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards
• Demonstrated skills in the areas of project management, organization, and execution as well as priority setting
• Proven experience developing and/or improving QMS, QE, and compliance programs
• Highly motivated, strategic thinker with a focus on continuous improvement and innovation, who endeavors to anticipate and resolve problems
• Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels
• Previous experience with the use of electronic document / quality management systems (EMDS / EQMS)
• Ability for occasional business travel

• Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC, etc
• Advanced degree in life science

competitive salaries and an excellent benefit package