Quality Assurance Manager

The Quality Assurance Manager develops and implements the organization’s total quality management strategy by (1) managing an enterprise-wide performance-monitoring program developed to identify quality deficiencies, analyze quality problems, and advance quality improvement initiatives; (2) supervising subordinate staff responsible for issuing and maintaining documented processes, policies and procedures within the organization’s quality management system; (4) ensuring that the enterprise training matrix is appropriately maintained and
updated; (5) communicating quality-related progress and issue resolution to appropriate internal/external stakeholders; (6) management of external audits while following established policies and standards for efficiency, accuracy, and security; and (7) serving as an SME on quality concepts, objectives, tools, and processes.

Quality Assurance is a departmental sub-function within a broader group that also is responsible for regulatory compliance, data privacy, data governance, procurement, vendor contracting, patents and ESG. QAM requires comprehensive knowledge of the managed sub-function in order to assume a team lead role. QAM also must have the ability to acquire and maintain a working knowledge of the adjacent subject matter areas and will be expected to be the quality SME on issues of risk assessment, supplier quality oversight and qualification, CAPAs, regulatory
inspections and external audits.

Responsibilities
• Manage a quality performance monitoring program that tracks and measures quality results and allows for the design of metrics that can be used to identify quality issues and process  deficiencies, analyze problems, and develop quality improvement initiatives.
• Host and lead virtual and/or on-site sponsor audits, certification and recertification audits, and regulatory inspection support, including communications and touchpoints with auditors and
internal impacted parties, coordination of data collection in advance of audits, serving as a POC for auditor requests and coordination with internal parties.
• Manages subordinate staff responsible for quality management system, including issuing and maintaining documented procedures, providing documentation requirements and preparation guidance.
• Capable of resolving escalated quality issues arising from operations and requiring coordination with other departments.
• Assists in the development, implementation and compliance of training on new / enhanced SOP management processes
• Serves as the primary point of contact for all quality-related inquiries and incidents, managing client relationships and coordinating with internal Greenphire employees to ensure timely
resolution. Stays current with applicable regulations, industry standards, and best practices to ensure compliance and continuous improvement.
• Drives Quality/risk-related tool implementations from a PM, user and tester perspective
• Takes an active role in educating the organization on quality standards, processes, and best practices through training, workshops, and ongoing communications.
• Perform other duties, assignments, and/or special projects as time or circumstances necessitate
• Travels to Greenphire headquarters when required

Qualifications
• Bachelor’s degree in engineering or similar area, or equivalent work experience and/or training
• Expertise in SaaS or proprietary software development
• Understanding of all phases of a software development life cycle preferred (in an agile environment a plus)
• Demonstrated quality leadership and expertise in supporting resolution of quality issues, investigations, CAPAs, and external audits

• ISO 27001 Lead Auditor certification (preferred)
• ISO 9001 Lead Auditor certification (preferred)
• Experience in Quality Control and Compliance, Quality Assurance, CAPA processes or Root Cause Analysis
• GxP experience within clinical research is a bonus, but not required
• Certified Software Quality Engineer (CSQE) certification is a bonus, but not required
• Direct document control and Quality Management Systems experience
• Experience planning/participating in external and internal audits
• Knowledge of Six Sigma methodologies (preferred)
• Experience in a highly regulated industry such as healthcare, finance or insurance (preferred)
• Able to motivate employees to achieve a culture of continuous improvement
• Detail oriented, ability to multi-task with strong prioritization, planning and organizational skills
• Ability to build cross functional relationships