Sr Manager Validation

<p style="text-align:left"><u><b>Work Schedule</b></u></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><u><b>Environmental Conditions</b></u></p>Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p><b>Senior Manager, Validation</b></p><p>Division/Site Specific Information</p><p>Thermo Fisher Scientific offers industry-leading pharma services through our Patheon™ brand, providing an integrated global network of scientific, technical, regulatory, and quality experts committed to helping deliver medicines to patients faster. The Mississauga site supports all phases of drug product development — from early-phase formulation development to clinical trial material to commercial supply — within the same facility using scalable equipment. The site supports non-GMP and GMP work for highly potent and low-potent compounds, complex formulations, pediatric dosage forms, patent-extension strategies, and conventional oral solid dosage forms.</p><p></p><p><b>Discover Impactful Work</b></p><p>As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Every day, our colleagues bring our Mission to life — enabling our customers to make the world healthier, cleaner, and safer.</p><p>In this senior leadership role, you will provide strategic and operational leadership for the Validation function, ensuring regulatory compliance, inspection readiness, and alignment with business objectives. You will partner cross-functionally across Operations, Pharmaceutical Development Services (PDS), Quality, Engineering, and with clients to establish validation strategy, drive continuous improvement, and support ongoing site growth.</p><p></p><p><b>Day in the Life</b></p><ul><li>Provide strategic leadership and technical oversight for all validation activities, ensuring alignment with GMP, regulatory expectations, and corporate standards</li><li>Lead and develop validation supervisors and technical staff, building organizational capability, technical depth, and succession readiness</li><li>Establish and drive site validation strategy, including automation initiatives, industry benchmarking, and adoption of evolving regulatory guidance</li><li>Represent the site in corporate validation initiatives, including Data Integrity (DI), Continued Process Verification (CPV), and global harmonization efforts</li><li>Partner with cross-functional leadership to develop and implement site- and network-level validation guidelines and best practices</li><li>Oversee planning, prioritization, and execution of validation programs and projects to meet manufacturing schedules and business commitments</li><li>Ensure approval and governance of validation protocols, reports, and departmental SOPs while maintaining inspection readiness</li><li>Serve as the senior liaison with clients and regulatory bodies regarding validation strategy, risk, and compliance matters</li><li>Provide oversight of validation resourcing, budgets, forecasting, and long-range planning; support proposal development as needed</li><li>Provide senior-level input into investigations, deviations, and risk assessments impacting validated systems and commercial processes</li><li>Promote a strong safety culture and ensure Environmental Health and Safety compliance across the validation organization</li><li>Lead talent management activities including hiring, performance management, development planning, and organizational design</li></ul><p></p><p><b>Keys to Success</b></p><p><b>Education</b></p><ul><li>Bachelor’s degree (required) in Science, Engineering, Pharmacy, or Business</li></ul><p></p><p><b>Experience</b></p><ul><li>Minimum 10 years of experience in Validation, Quality Assurance, Regulatory, or a cGMP-regulated contract manufacturing environment</li><li>Minimum 5 years of people leadership experience</li><li>Demonstrated experience leading complex validation programs and cross-functional initiatives</li><li>Proven ability to interface with clients, auditors, and regulatory agencies at a senior level</li></ul><p></p><p><i>Equivalent combinations of education, training, and relevant work experience may be considered.</i></p><p></p><p><b>Knowledge, Skills, Abilities</b></p><p><b>Knowledge</b></p><ul><li>Strong understanding of manufacturing and operational processes</li><li>Excellent knowledge of Good Manufacturing Practices (GMP) and FDA regulatory expectations</li></ul><p><b>Skills</b></p><ul><li>Strong interpersonal and written/oral communication skills</li><li>Ability to influence, motivate, and lead across organizational levels</li><li>Strong planning, prioritization, and deadline-management skills</li><li>Proficiency with Microsoft Office applications</li></ul><p><b>Abilities</b></p><ul><li>Comfortable working with senior leadership, cross-functional partners, and external clients</li><li>Ability to manage multiple complex priorities simultaneously</li><li>Proficiency in the English language</li></ul><p></p><p><b>Benefits</b></p><p>We offer competitive remuneration, an annual incentive plan, comprehensive healthcare, and a wide range of employee benefits. Thermo Fisher Scientific provides an innovative, forward-thinking work environment with outstanding career and development opportunities.</p><ul><li>Medical, Dental, &amp; Vision benefits — effective Day 1</li><li>Paid Time Off &amp; Designated Paid Holidays</li><li>Retirement Savings Plan</li><li>Tuition Reimbursement</li></ul><p></p><p></p><p style="text-align:inherit"></p><p style="text-align:left"><u><b>Compensation</b></u></p>The salary range estimated for this position based in Canada is $106,600.00–$155,000.00.<p></p><p></p><p></p><p></p>