Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 AgreementsEnhance the Quality Culture at the site via “Right From Me” huddles, GEMBA, and other Quality culture improvement initiativesProvide 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 expectationsCoordinate and perform Quality Systems linked to Deviations and CAPA initiativesProvide quarterly Investigation and CAPA evaluations within the Compliance department and ensure a plan of action and follow-ups to measure the effectiveness of implemented actionsEvaluate, challenge, and implement quality improvements to processes across Development, Commercial, and Quality operationsPartner 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 personnelManage departmental budget and capacity for proper staffing and expensesMaintain 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 reviewPerform periodic reviews on the sustainability of new and existing risk initiativesPromote a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety proceduresSelect, 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 industryMinimum 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 knowledgeHighly developed quality, regulatory, and operational approach with an appreciation for client service and the contract manufacturing industryDemonstrated leadership and problem-solving abilitiesAbility to prioritize multiple project deliverablesAbility to empower and influenceOrganized and diligentExcellent written and verbal communication skillsAbility to risk assess and facilitate remediation of site quality systems against corporate policies, SOPs, and regulatory requirementsProficiency with the English Language

Standards and Expectations:

Follow all Environmental Health & Safety Policies and ProceduresWork collaboratively with fellow team members, model positive team principles and partner to meet project and departmental objectivesCarry out all duties in compliance with Thermo Fisher quality SOPs and GMPActively 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 timesUnderstand Key Performance Indicators and aim to improve the performance of the team by identifying areas for system improvements and engaging in problem-solvingModel positive thinking and be open to change, motivating the team to adapt to shifts in priorities and new ways of workingProactively identify areas for improvementCommunicate risks to the timelines of results in a proactive mannerConsistently aim to improve skills and knowledge in compliance

Physical Requirements:

There is little physical effort and fatigueWalks, sits, or stands for limited periodsMay require occasional equipment operation including keyboard equipmentLifts light items for a limited durationTypically located in a comfortable indoor areaThere may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lightsFrequent 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.