Quality/Compliance Manager

Responsibilities

• Perform investigations of significant event deviations along with the corresponding root cause analysis (RCA), impact assessment and trend evaluations.
• Lead assigned Corrective and Preventive Actions (CAPA) Developments and reviews of trend analysis reports related to the facility scope of work.
• Manage the GxP Contractors compliance program (e.g. qualification, agreements, audits, performances, etc.).
• Oversee the quality/compliance program as it relates to facility support systems including maintenance of equipment, environmental monitoring systems, HVAC, utilities, and site support services such as calibration, janitorial cleaning, pest control, garments, and shipping/receiving activities.
• Manage the site’s self-assessment program along with the corrective actions as a result of.
• Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements.
• Support and oversee the team’s training compliance program along with the review of corresponding training curricula.
• Ensures appropriate follow up with customers.
• Seeks to continuously improve quality processes, systems and overall client satisfaction.
• Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.

Requirements

• BA/BS in Science is preferred, or equivalent quality engineering and production/facility operations experience.
• Minimum of three to five (5+) years of experience in Pharma, Biotech or similar life science sector that are governed in GMP regulations, systems and processes working in a Quality Assurance role.
• Knowledge of Quality Engineering techniques such as Investigations, RCAs, CAPAs, Audit programs, Vendor Qualification, and Quality Management Systems
• EIT or PE a plus
• Strong working knowledge of computer applications, including MSOffice
• Working knowledge of Quality System such as TrackWise, Success Factors, Infinity, etc.
• Demonstrated verbal/written communication skills
• Proven record of excellent internal and external customer service