Manager, QAIP Manufacturing and Packaging

Job Summary

This is a Quality position for the Richmond Hill site to manage shop floor quality compliance, including oversight of associated Master documentation review and approvals; it is to ensure all sterile and non-sterile manufacturing related activities are conducted in compliance with current corporate and regulatory requirements.

Job Responsibilities

• Accountable for shop floor quality compliance for sterile and non-sterile manufacturing:
• Manage the QAIP (QA In-Process) team to provide on-line quality support to the site manufacturing operations.
  • Quality oversight of production and associated Master documentation related activities to assure GMP compliance that best support the business.
  • Management of retain samples
• Active participation in cross-functional project teams to assure all validation and launch activities are fulfilled in accordance with project timelines
• Interact with regulatory agencies and professional colleagues to review and defend shop floor quality practices in audits

• 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 shop floor compliance.
• Responsible for application and enhancement of Quality Systems, and establishment of metrics to measure effectiveness of the system. 
• Support change through review, assessment and approval of Change Control Requests (CCRs) in TrackWise (or equivalent quality system), as required.

• Develop, maintain and publish performance measures.

• In conjunction with Associate Director, Quality Operations – RH, conduct appropriate resource planning analysis and submits forecasts for headcount, capital and expense budget.Work with the Human Resources group to recruit and hire for open and approved new positions
• Assist Associate Director, Quality Operations - RH in achieving departmental goals and objectives

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

2. Manage employee performance / development / administration, which includes, but is not limited to:

• 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 in Applied Sciences and/or Pharmaceutical Engineering.
• Knowledge, Skills and Abilities
  • Sound knowledge of GMP and current regulatory requirements (from Health Canada, FDA, and EU) on sterile and non-sterile manufacturing
• 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 mind-set
• 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 Quality Operations (preferably on shop floor).
  • Minimum 5 years of management experience, preferably in the pharmaceutical or equivalent industry