Sr Manager Validation
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Job Location:
Mississauga - Canada
Monthly Salary:
$ 106600 - 155000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 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.
Discover Impactful Work
As part of the Thermo Fisher Scientific team youll 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.
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
- Bachelors 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 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 $106600.00$155000.00.Required Experience:
Manager
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
