Principal Quality Systems Compliance Specialist

Role Summary

Principal Quality Systems Compliance Specialist

Responsibilities

• Own the Quality Systems metrics process
• Lead and support individuals and teams through root cause analysis investigations
• Facilitate investigations into quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
• Ability to work collaboratively within Quality Assurance functions to gather information and drive timelines
• Generate and monitor metrics (KPI's) for all Quality Operations regarding Quality Management Review
• Strong technical expertise of QA/QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems
• Reflects solid understanding of strategies, goals and can take part in major parts of projects, or provide expert service
• Provide guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards
• Review and revise relevant policies and procedures to maintain adherence to regulations
• Maintain current knowledge of regulations, standards, and guidance documents
• Present metrics to area leadership
• Collaborate cross-functionally with Supply Chain, Manufacturing, Process Engineering, Regulatory and other groups as needed to meet schedule requirements and resolve challenges
• Represent QA in meetings or on project teams, exercising broad authority in decision making and commitments on behalf of QA, elevating only those issues that require buy-in from department Leadership
• Lead and/or participate in inspection readiness and process improvement initiatives
• Support regulatory inspections from a quality system perspective
• Manage the Material Review board
• Work to further develop and imbue a Quality culture
• Contributes to the development and implementation of continuous quality improvement initiatives
• Ability to participate in and/or lead risk assessments
• Support and/or lead other quality initiatives as needed

Qualifications

• Expert knowledge of root cause analysis process with demonstrated ability to utilize common RCA tools
• Skilled in technical writing and analytical problem-solving
• Must be able to drill down to the true root cause of issues and understand that ‚Äúhuman error‚Äù is an exception and not the rule
• Proficient knowledge of cGMP, with a focus on Drug Product / Combination Product aspects of the MFG process/batch records
• Product development process knowledge a plus
• Ability to make sound compliance-related decisions with minimal supervision
• Must possess strong attention to detail
• Ability to navigate computerized programs such as AssurX (eQMS)
• Strong communication (written and verbal) and organizational skills
• Ability to independently manage multiple priorities in a dynamic environment
• High level of personal/departmental accountability and responsibility
• Creatively use business concepts and company policies/procedures to solve problems
• Excellent complex problem-solving and teamwork skills
• Proficient at resolving issues in creative and innovative ways
• Exercises good judgment in selecting methods/techniques to achieve positive results

Other Requirements

• Presence at both the Watertown and Northridge locations may be required to build relationships with both teams
• Preference will be given to someone who has supported quality systems from both a GMP and GCP perspective

Education

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

Experience

• 8+ years‚Äô experience working in a biopharmaceutical/pharmaceutical environment