Principal Quality Systems Compliance Specialist

Role Summary

Principal Quality Systems Compliance Specialist responsible for leading quality systems, driving root cause investigations, and supporting regulatory inspections. Works across Quality Assurance, Manufacturing, Process Engineering, Regulatory, and Supply Chain to maintain cGMP-compliant quality systems and continuous quality improvement. This role can be based in Northbridge, MA or Watertown, MA with a hybrid work schedule.

Responsibilities

• Own the Quality Systems metrics process
• Lead and support individuals and teams through root cause analysis investigations
• Facilitate investigations into quality issues, identify root causes, develop corrective and preventive actions, track actions and confirm effectiveness
• Collaborate within Quality Assurance functions to gather information and drive timelines
• Generate and monitor metrics (KPIs) for Quality Operations and Quality Management Review
• Provide strong technical expertise of QA/QC and Manufacturing to support development and maintenance of cGMP quality systems
• Contribute to project strategy and provide expert service
• Guide development of corrective and preventive actions based on GxP requirements and industry standards
• Review and revise policies and procedures to ensure regulatory adherence
• Maintain knowledge of regulations, standards, and guidance documents
• Present metrics to area leadership
• Collaborate cross-functionally with Supply Chain, Manufacturing, Process Engineering, Regulatory and others to meet schedules and resolve challenges
• Represent QA in meetings or project teams, exercising broad authority in decisions on behalf of QA
• Lead and/or participate in inspection readiness and process improvement initiatives
• Support regulatory inspections from a quality system perspective
• Manage the Material Review Board
• Foster a Quality culture and contribute to continuous quality improvement initiatives
• Participate in and/or lead risk assessments
• Support and/or lead other quality initiatives as needed

Qualifications

• Expert knowledge of root cause analysis with ability to use common RCA tools
• Skilled in technical writing and analytical problem-solving
• Ability to drill down to true root causes and view human error as an exception
• Proficient knowledge of cGMP, with focus on Drug Product / Combination Product aspects of manufacturing
• Product development process knowledge is a plus
• Ability to make sound compliance-related decisions with minimal supervision
• Strong attention to detail
• Ability to navigate computerized programs such as AssurX (eQMS)
• Strong written and verbal communication and organizational skills
• Ability to manage multiple priorities in a dynamic environment
• High level of personal/departmental accountability
• Creatively apply business concepts and policies to solve problems
• Excellent complex problem-solving and teamwork skills
• Proficient at resolving issues in creative and innovative ways
• Good judgment in selecting methods/techniques to achieve positive results

Skills

• Root cause analysis
• Technical writing
• GxP compliance
• Quality metrics and KPIs
• cGMP knowledge (Drug Product / Combination Product)
• Project collaboration and cross-functional teamwork
• Regulatory inspection readiness

Education

• Bachelor of Science or a combination of Bachelor degree and industry experience

Additional Requirements

• Presence at both the Watertown and Northridge locations may be required to build relationships with both teams
• Preference given to candidates with experience supporting quality systems from both GMP and GCP perspectives