Manager, Manager, Quality Validation &Engineering

Job Summary

This is a Quality position for the Richmond Hill site to ensure all GMP facilities, utility systems, equipment, and processes for both sterile and non-sterile manufacturing are fully validated and in compliance with current corporate and regulatory requirements.

Job Responsibilities

• Provide Quality direction and approval to ensure all validation activities / status are conducted and maintained in accordance with corporate policies and regulatory requirements:
• Accountable for the maintenance of and continuous improvement to all sterile and cleaning validation, include but not limited to the following:
• Aseptic Process Simulations (media fills)
• Aseptic operator qualification
• Thermal (moist / dry Heat) and gaseous (VHP / ETO)validation
• Irradiation (gamma / e-beam) of primary packaging components
• Container closure integrity
• Sterilizing filter validation
• Equipment cleaning validation & routine monitoring
• Provide Quality guidance,review & approval of,but not limited to the following:
• Maintenance & Validation of facility, utility systems, and equipment
• Manufacturing process validation
• Critical instrument(include HEPA filter)certification and calibration
• Provide Quality guidance / assessment to ensure the maintenance of and changes to the validated systems, equipment and processes are managed in accordance with current corporate and regulatory requirements. Participate as QA subject matter expert (SME) in investigations related to validation, calibration and maintenance. Participate in review of Preventative Maintenance and Calibration trends.
• Active participation in cross-functional project teams to assure all validation activities are fulfilled in accordance with project timelines.
• Provide validation support for all regulatory submissions, audits, & responses.
• Interact with regulatory agencies and professional colleagues to review and defend the site validation practices in audits.
• Maintain current knowledge of regulatory requirements; review and revise processes to optimize compliance and business efficiency:
• Develop and maintain thorough knowledge of Canadian and international GMP requirements as they relate to pharmaceutical production. Acts as an expert resource for the organization on regulatory requirements/trends as they relate to validation activities.
• Support change through review, assessment and approval of Change Control Requests (CCRs) in TrackWise (or equivalent quality system), as required.
• General responsibilities:
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

• Education
  • Bachelor of Science Degree (preferably M.Sc.) in Applied Sciences and/or Pharmaceutical Engineering.
• Knowledge, Skills and Abilities
  • Sound knowledge of GMP, current regulatory requirements and industry standards on a wide spectrum of validation in the pharmaceutical industry
  • Excellent command of the English language, both written and verbal
  • Superior organizational, time management, interpersonal, communication, and team-building skills
  • Customer-service and quality-oriented mindset
  • Proven ability to lead and motivate subordinates
  • Excellent problem-solving and troubleshooting abilities
  • Proven ability to manage multiple priorities and make sound decisions in a fast-paced and changing environment
  • Proven success in interacting with regulatory agencies in audits
  • Proven experience in project management; proficient with various statistical process control and risk management tools (e.g. FMEA)
  • Proficient with Microsoft Office tools (e.g. Word, Excel, PowerPoint, Visio and Access)
• Experience
  • Minimum 7-10 years of experience in a GMP-regulated industry, 5 years of which has been spent in a validation role.
  • Minimum 5 years of management experience, preferably in the pharmaceutical or equivalent industry.