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Quality Compliance Manager

Company: PRS
Location: Andover
Posted on: August 7, 2022

Job Description:

We have an exciting opportunity for an experienced Quality Compliance Manager to join a global commercial real estate services business in Andover, MA Managing background in quality assurance requirements for Biotech/Pharmaceutical facility operations and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities Operations and Maintenance teams, and its subcontractors perform the work in full accordance and compliance with client policies and procedures, and FDA cGMP regulations. The Manager role must have a solid understanding of cGMP's as they relate to the performance of maintenance and repairs to equipment utilized for the manufacturing of drug products and control of workplace environment. It is vital that they ensure all staff and subcontractors are compliant with all client and regulatory training. Essential Duties: Customer Relationships (Client)

  • Ensure client satisfaction with delivery of facility management services and provide a lead role in monitoring and increasing regulatory and statutory compliance.
  • Develop excellent partnership with clients through trust, actions and results
  • Comply with all GMP and Non-GMP requirements of the Client contracts and meet or exceed key performance indicators.
  • Deliver an exceptional quality of service to the clients, as reflected by client feedback.
  • Ensure training compliance within our clients scope of work.
  • Be an active member of our clients Life Sciences Quality Council, participate in and lead initiatives, share learnings with the council and share best practices and improvement to the accountsLeadership Management (People)
    • Foster a proactive environment of teamwork, cooperation, excellence of performance and personal success.
    • Act as role model for our client by behaving consistently with cultural, ethical requirements and participating in company activities.
    • Support individual performance management program, and responsible for personal development planning process.
    • Promote safety culture within portfolio including clients, subcontractors, suppliers and visitors.Service Delivery (Growth)
      • Primary responsibility is to lead regulatory and quality assurance programs and requirements in a GxP environment by ensuring all facilities services and documentation in full accordance and compliance with client policies and procedures, and FDA cGMP regulations.
      • Accountable to provide specific quality assurance assistance to the facility management teams as needed or requested.
      • Responsible for executing our clients Quality Compliance program for cGMP manufacturing facilities such as training verification, facility self-assessment, documentation control, vendor/suppliers audits and site programs relating to regulatory or statutory compliance.
      • Reads and understands the applicable Service Level Agreements, helps achieve the Key Performance Indicators and scores favorably on the client satisfaction surveys.
      • Support EHS teams in full compliance with all EHS programs requirements.
      • Responsible to prepare and revise SOP's, change control documentation, investigations, discrepancies, CAPA's, GDP's and training materials used by the facilities maintenance team in the performance of their work and also is accountable to keep updated applicable quality management system or software (Ex. TrackWise) in place.
      • Interface with the client's SME's to ensure that applicable client SOP's are followed, and that the work performed by the team is documented and recorded for accuracy and compliance with all applicable regulations, international standards, and internal procedures.
      • Review, consult, and approve (as authorized) risk analysis performed for facilities operation at site level.
      • Comply with all GMP and Non-GMP requirements of the client contract and meet or exceed key compliance requirements.
        --- Ensure compliance of all regulatory laws and guidelines are met in accordance to their SOP's by maintaining our clients practices across all facilities services to meet client and authority having jurisdiction (AHJ) compliance requirements.
        • Lead in the completion of the facilities operations audits and assessments requirements, and full responsible of site audit readiness program.
        • Support Business Continuity Planning activities, and participate as a key team member in responses to emergency situations.
        • Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.
        • Owns program processes and ensures all requirements for facility are met.
        • Execute additional job duties as requests, analysis and reporting.
        • Seeks to continuously improve quality processes, systems and overall client satisfaction.Account Specific Responsibilities:
          • Audit GxP Work Orders sample sets and GxP documentation for completeness and accuracy
          • KPI Scorecard review and governance
          • Participate, prepare, and lead, if applicable, internal and external audits
          • Provide Quality training as needed
          • Coordinate and manage GxP vendors, including vendor qualification packages, audits, and monitoring service performance
          • CAPAs creation, review, closeout and lessons learned
          • Assure ongoing compliance with our clients Quality, Client Quality, and Regulatory requirements
          • Prepare reports to communicate outcomes of quality activities
          • Interpret and implement quality assurance standards
          • Draft and execute client quality agreements
          • Lead and/or Significant Events/Deviations investigations
          • Review GxP Change ManagementQualifications:
            • BA/BS in engineering is preferred, or equivalent quality engineering and production/facility operations experience.
            • Have a minimum of four to seven (4+) years of regulatory quality and statutory compliance experience
            • Have a minimum of 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, CMMS systems, and Quality Management Systems
            • Proven record of excellent internal and external customer service
            • Excellent verbal and written communication skills
            • Advanced computer and office software skills is required

Keywords: PRS, Boston , Quality Compliance Manager, Executive , Andover, Massachusetts

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