Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day, enabling our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, including protecting the environment, ensuring food safety and helping find cures for cancer.

Location: Onsite M-F Mississauga, Ontario

DESCRIPTION
Join us as a Manager, Quality Assurance – Production Documentation and Laboratory Data Review, where you will lead the Quality Assurance teams responsible for Production Documentation Review and Release and Laboratory Data Review, related to Pharmaceutical Development Services (PDS) and Commercial operations.

You will be accountable for the timely, accurate and compliant review of executed GMP production documentation, laboratory data and associated records, as well as batch disposition. Your teams will ensure records are complete, accurate, traceable and compliant with approved procedures, specifications, regulatory requirements and data integrity expectations.

Working closely with Manufacturing, Laboratory Operations, Quality Systems, Validation and other cross-functional partners, you will establish priorities, balance resources and support production, testing review and batch review & release timelines. You will use performance metrics and quality trends to strengthen right-first-time performance, data integrity, review efficiency and inspection readiness.

As a Quality leader, you will develop supervisors and reviewers, standardize review practices and foster a culture of quality, accountability, collaboration and continuous improvement.
 

KEY RESPONSIBILITIES

Leadership and Team Development
• Lead, develop and provide strategic direction for one Production Documentation Review team and three Laboratory Data Review teams.
• Establish clear goals, performance expectations, priorities and workload plans across the review organization.
• Develop supervisors and individual contributors through coaching, technical guidance, performance feedback and succession planning.
• Ensure appropriate staffing, training and technical competency to meet documentation review, laboratory data review and batch-disposition requirements.
Quality Assurance Oversight
• Oversee the timely review and approval of executed batch records, electronic production records, logbooks, forms, laboratory data, analytical records and other supporting GMP documentation.
• Ensure production and laboratory records are reviewed for completeness, accuracy, consistency, traceability and compliance with approved procedures, test methods, specifications and applicable regulatory requirements.
• Ensure consistent application of good documentation practices and ALCOA+ data integrity principles across review activities.
• Ensure documentation discrepancies, data anomalies, atypical results and potential compliance or data integrity concerns are appropriately identified, assessed, investigated, escalated and resolved.
• Provide Quality Assurance oversight for issues that may affect product quality, data reliability, batch disposition or regulatory compliance.Operational

Performance and Continuous Improvement
• Monitor capacity, workload and review queues, proactively addressing backlogs, bottlenecks and changing business priorities.
• Develop and monitor key performance indicators, including review cycle time, backlog, on-time completion, error rates, repeat observations and right-first-time performance.
• Analyze performance and quality trends to identify systemic risks and opportunities for improvement.
• Partner with Manufacturing, Laboratory Operations and other functions to improve documentation quality, data accuracy, review efficiency and right-first-time performance.
• Lead improvements to review workflows, electronic systems and automation that enhance efficiency, consistency and data integrity.
 

Quality Systems and Compliance
• Support deviations, investigations, corrective and preventive actions, change controls and quality risk assessments related to production documentation and laboratory data.
• Develop, revise and approve procedures, work instructions, review checklists and training materials, ensuring consistent review practices across teams.
• Support regulatory inspections, customer audits and internal audits, including presentation of review processes, performance metrics and quality-system records.
• Maintain inspection readiness and ensure records are complete, accurate, organized and readily retrievable.
• Escalate significant product-quality, compliance, operational or data integrity risks to Quality and site leadership.
 

REQUIREMENTS
• Degree in Chemistry, Biology, Biochemistry..
• Advanced degree with at least 6 years of relevant experience, or bachelor’s degree with at least 8 years of relevant experience, in a GMP-regulated pharmaceutical, biopharmaceutical or related environment.
• At least 3 years of people-management experience, preferably leading multiple teams, functional groups or team leaders.
• Demonstrated experience with GMP production documentation, executed batch records, laboratory data and associated analytical documentation.
• Experience leading documentation review, laboratory data review, batch-record review and batch-disposition support activities.
• Demonstrated ability to manage multiple teams, resources, review queues and competing production and laboratory priorities while maintaining compliance and review quality.
• Comprehensive knowledge of applicable GMP regulations and guidance, including FDA, Health Canada, ICH, EMA, PMDA, WHO requirements.
• Strong knowledge of good documentation practices, ALCOA+ data integrity principles, and electronic records and electronic signature requirements, including 21 CFR Part 11 and EU Annex 11.
• Working knowledge of laboratory testing, analytical methods, specifications and laboratory data systems, including the evaluation of data anomalies, atypical results and potential data integrity concerns.
• Knowledge of laboratory investigation processes, including out-of-specification, out-of-trend and atypical-result investigations, preferred.
• Strong knowledge of quality systems, including deviations, investigations, CAPA, change control, document control, training and quality risk management.
• Demonstrated success developing leaders, coaching Quality Assurance personnel and building high-performing teams.
• Experience supporting regulatory inspections, customer audits and internal audits.
• Strong analytical and problem-solving capabilities, including the use of quality metrics, capacity data and trend analysis to drive decisions and continuous improvement.
• Excellent written and verbal communication
• Experience with electronic quality, document, laboratory and manufacturing systems. Familiarity with platforms such as TrackWise, LIMS, Empower, SAP, MES or similar systems preferred.
• Knowledge of continuous improvement methodologies and quality risk-management tools; Six Sigma or another relevant quality certification preferred.
• Ability to provide support for urgent quality events outside standard business hours, as needed.

Compensation