Quality Systems Manager

Vertex Pharmaceuticals • Boston, MA

1d • $134,202 - $164,400 • Hybrid

About The Position

Collaborate with internal and external business partners and cross-functional teams to resolve complex quality and operational issues, ensuring compliant and efficient solutions. Draft, review, and maintain process-specific Standard Operating Procedures (SOPs) and Work Instructions to ensure they remain compliant and up to date. Analyze workflows, quality systems, and production processes to identify inefficiencies, compliance gaps, and areas for continuous improvement. Develop and implement effective solutions, encompassing enhancements to cross-functional quality systems and operational processes, ensuring adherence to industry standards and regulations including 21 CFR Parts 4 and 820, ISO 13485, and ISO 14971. Participate as a technical resource in cross-functional teams, providing expertise in quality investigations, deviations, and operational issues. Conduct thorough root cause analyses and product impact assessments for investigations resulting from deviations, OOS, or operational inefficiencies, and propose corrective and preventive action plans (CAPAs). Approve investigations, CAPAs, and change controls, and assist Change Control owners in ensuring compliance with change procedure requirements. Support vendor quality management activities, including evaluating vendor quality systems and assisting in resolving vendor-related quality issues. Design and implement metrics and reporting systems using tools including Power BI to analyze data, identify trends, and guide decision-making. Drive continual improvement initiatives through Lean, Six Sigma, and other quality and operational methodologies. Develop, maintain , and deliver training curricula for team members, providing guidance on compliance, quality standards, and operational best practices. Identify risks in quality systems and production processes, communicate them effectively to stakeholders, and assist with risk mitigation plans. Coordinate and follow up on management action items, and ensure timely completion of assigned tasks.

Requirements

• Employer will accept a Bachelor’s Engineering, Life Sciences, Industrial and Technical Studies, or a related field and 5 years of experience in the job offered or in Quality Systems Manager - related occupation.
• A minimum of 3 years of experience in the medical devices field.
• In-depth knowledge of both the conceptual and practical application of cGMPs in a medical device setting, as well as knowledge of global GMP requirements and the ability to provide quality oversight, guidance, and compliance support to GMP manufacturing operations.
• In-depth experience leading complex projects and teams and continuous improvement initiatives within stated objectives and timelines; effectively apply project management processes and tools to plan deliverables, track progress, lead project meetings, and ensure timely completion of milestones.
• Facilitate collaboration between departments and setting clear quality expectations during risk-based decision making, effectively representing the Quality unit.
• Experience leading event investigations, Root Cause Analysis (RCA), and corrective and preventive action plans (CAPAs).
• Experience working with electronic management systems, including Veeva, to manage workflows related to document management systems, including SOPs, and Work Instructions.
• Experience examining deviations and CAPA processes to ensure timely review and closure.

Responsibilities

• Collaborate with internal and external business partners and cross-functional teams to resolve complex quality and operational issues, ensuring compliant and efficient solutions.
• Draft, review, and maintain process-specific Standard Operating Procedures (SOPs) and Work Instructions to ensure they remain compliant and up to date.
• Analyze workflows, quality systems, and production processes to identify inefficiencies, compliance gaps, and areas for continuous improvement.
• Develop and implement effective solutions, encompassing enhancements to cross-functional quality systems and operational processes, ensuring adherence to industry standards and regulations including 21 CFR Parts 4 and 820, ISO 13485, and ISO 14971.
• Participate as a technical resource in cross-functional teams, providing expertise in quality investigations, deviations, and operational issues.
• Conduct thorough root cause analyses and product impact assessments for investigations resulting from deviations, OOS, or operational inefficiencies, and propose corrective and preventive action plans (CAPAs).
• Approve investigations, CAPAs, and change controls, and assist Change Control owners in ensuring compliance with change procedure requirements.
• Support vendor quality management activities, including evaluating vendor quality systems and assisting in resolving vendor-related quality issues.
• Design and implement metrics and reporting systems using tools including Power BI to analyze data, identify trends, and guide decision-making.
• Drive continual improvement initiatives through Lean, Six Sigma, and other quality and operational methodologies.
• Develop, maintain , and deliver training curricula for team members, providing guidance on compliance, quality standards, and operational best practices.
• Identify risks in quality systems and production processes, communicate them effectively to stakeholders, and assist with risk mitigation plans.
• Coordinate and follow up on management action items, and ensure timely completion of assigned tasks.

Benefits

• annual bonus
• annual equity awards
• medical, dental and vision benefits
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• educational assistance programs including student loan repayment
• a generous commuting subsidy
• matching charitable donations
• 401(k)
• inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees