Sr Manager Validation

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
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.)
**Job Description**
**Senior Manager, Validation**
Division/Site Specific Information
Thermo Fisher Scientific offers industry-leading pharma services through our Patheonu2122 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 u2014 from early-phase formulation development to clinical trial material to commercial supply u2014 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.
**Discover Impactful Work**
As part of the Thermo Fisher Scientific team, youu2019ll discover meaningful work that makes a positive impact on a global scale. Every day, our colleagues bring our Mission to life u2014 enabling our customers to make the world healthier, cleaner, and safer.
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.
**Day in the Life**
Provide strategic leadership and technical oversight for all validation activities, ensuring alignment with GMP, regulatory expectations, and corporate standards
Lead and develop validation supervisors and technical staff, building organizational capability, technical depth, and succession readiness
Establish and drive site validation strategy, including automation initiatives, industry benchmarking, and adoption of evolving regulatory guidance
Represent the site in corporate validation initiatives, including Data Integrity (DI), Continued Process Verification (CPV), and global harmonization efforts
Partner with cross-functional leadership to develop and implement site- and network-level validation guidelines and best practices
Oversee planning, prioritization, and execution of validation programs and projects to meet manufacturing schedules and business commitments
Ensure approval and governance of validation protocols, reports, and departmental SOPs while maintaining inspection readiness
Serve as the senior liaison with clients and regulatory bodies regarding validation strategy, risk, and compliance matters
Provide oversight of validation resourcing, budgets, forecasting, and long-range planning; support proposal development as needed
Provide senior-level input into investigations, deviations, and risk assessments impacting validated systems and commercial processes
Promote a strong safety culture and ensure Environmental Health and Safety compliance across the validation organization
Lead talent management activities including hiring, performance management, development planning, and organizational design
**Keys to Success**
**Education**
Bacheloru2019s degree (required) in Science, Engineering, Pharmacy, or Business
**Experience**
Minimum 10 years of experience in Validation, Quality Assurance, Regulatory, or a cGMP-regulated contract manufacturing environment
Minimum 5 years of people leadership experience
Demonstrated experience leading complex validation programs and cross-functional initiatives
Proven ability to interface with clients, auditors, and regulatory agencies at a senior level
_Equivalent combinations of education, training, and relevant work experience may be considered._
**Knowledge, Skills, Abilities**
**Knowledge**
Strong understanding of manufacturing and operational processes
Excellent knowledge of Good Manufacturing Practices (GMP) and FDA regulatory expectations
**Skills**
Strong interpersonal and written/oral communication skills
Ability to influence, motivate, and lead across organizational levels
Strong planning, prioritization, and deadline-management skills
Proficiency with Microsoft Office applications
**Abilities**
Comfortable working with senior leadership, cross-functional partners, and external clients
Ability to manage multiple complex priorities simultaneously
Proficiency in the English language
**Benefits**
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.
Medical, Dental, & Vision benefits u2014 effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
**Compensation**
The salary range estimated for this position based in Canada is $106,600.00u2013$155,000.00.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.