Sr. Manager, Quality and Compliance

Work Schedule

Environmental Conditions

Job Description

How will you make an impact?

We are seeking a dedicated and ambitious Sr. Manager, Quality and Compliance to join our team at Thermo Fisher Scientific Inc. in Mississauga, ON, Canada. This role provides an opportunity to lead and manage our Compliance Program, ensuring our Compliance/Quality Systems meet Health Canada, FDA, and EMA GMP requirements. As a member of the site Quality Leadership Team, you will drive a culture of quality and customer-centricity to enable excellence in Quality performance, Right First Time Delivery, and a great customer experience in our Commercial and Pharmaceutical Development Services (PDS) businesses.

What will you do:

Manage teams responsible for reporting and site governance of Quality Bowler (and associated metrics), Document Control, Audits, Vendor Management, Regulatory & Licensing activities, Risk Management, Quality Management Review, Quality Systems and oversee the management of Controlled Substances at our site.

§ Lead a team of Quality and Compliance Managers

• Ensure Customers and Patheon are operating in compliance with Quality Agreements
• Enhance the Quality Culture at the site via "Right From Me" huddles, GEMBA, and other Quality culture improvement initiatives
• Provide oversight to Quality Project Managers to ensure an exceptional customer experience and flawless GMP compliance

§ Ensure that critical issues are handled and investigated accordingly

• Establish facility compliance systems as per FDA, Health Canada, EMA, and other Regulatory Agency requirements through internal audits and strategy meetings

§ Ensure the facility is always inspection ready

• Oversee and assist with the vendor management program to meet compliance expectations
• Coordinate and perform Quality Systems linked to Deviations and CAPA initiatives
• Provide quarterly Investigation and CAPA evaluations within the Compliance department and ensure a plan of action and follow-ups to measure the effectiveness of implemented actions
• Evaluate, challenge, and implement quality improvements to processes across Development, Commercial, and Quality operations
• Partner with the site investigation team to resolve deviations and oversee the management of controlled drugs at the site to meet Office of Controlled Substances requirements

§ Provide timely responses to client regulatory requests

• Provide leadership, mentoring, and coaching for direct reports and site personnel
• Manage departmental budget and capacity for proper staffing and expenses
• Maintain a regulatory watch for GMP and regulatory updates

§ Manage multiple small-medium projects and/or improvement initiatives

• Manage Failure Mode and Effect Analysis (FMEAs) for site improvements associated with construction, expansion, site deviations, product deviations, complaints, tech transfers, and validation

§ Manage complaints to meet timelines and client expectations

• Own the Site Risk Management process and facilitate the monthly SLT risk review
• Perform periodic reviews on the sustainability of new and existing risk initiatives
• Promote a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures
• Select, develop, and evaluate staff to ensure the efficient operation of the function

How will you get here?

Education:

• BSc or equivalent experience in Chemistry, Pharmacy, or a science related to pharmaceutical analysis. Candidates with degrees outside of Canada must provide evidence of education equivalency to meet regulatory compliance for all hires, promotions, or transfers to this role.

Experience:

• Minimum 8 years of experience in quality within the pharmaceutical industry
• Minimum 10 years of management and/or leadership experience

Equivalency:

• Equivalent education, training, and relevant work experience combinations may be considered.

Knowledge, Skills, and Abilities:

• Exceptional cGMP, Health Canada, FDA, EMA compliance knowledge
• Highly developed quality, regulatory, and operational approach with an appreciation for client service and the contract manufacturing industry
• Demonstrated leadership and problem-solving abilities
• Ability to prioritize multiple project deliverables
• Ability to empower and influence
• Organized and diligent
• Excellent written and verbal communication skills
• Ability to risk assess and facilitate remediation of site quality systems against corporate policies, SOPs, and regulatory requirements
• Proficiency with the English Language

Standards and Expectations:

• Follow all Environmental Health & Safety Policies and Procedures
• Work collaboratively with fellow team members, model positive team principles and partner to meet project and departmental objectives
• Carry out all duties in compliance with Thermo Fisher quality SOPs and GMP
• Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems)
• Be client and patient-conscious at all times
• Understand Key Performance Indicators and aim to improve the performance of the team by identifying areas for system improvements and engaging in problem-solving
• Model positive thinking and be open to change, motivating the team to adapt to shifts in priorities and new ways of working
• Proactively identify areas for improvement
• Communicate risks to the timelines of results in a proactive manner
• Consistently aim to improve skills and knowledge in compliance

Physical Requirements:

• There is little physical effort and fatigue
• Walks, sits, or stands for limited periods
• May require occasional equipment operation including keyboard equipment
• Lifts light items for a limited duration
• Typically located in a comfortable indoor area
• There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights
• Frequent need to distinguish among or interpret a variety of sensory inputs that require attention to decode and identify (e.g., deciphering hand-written notes)

• Benefits

  We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.