Senior Specialist, Quality Assurance

Key Responsibilities

GMP Operations Quality Oversight

• Reviews and approves laboratory investigations (e.g., OOS/OOT/deviations) conducted by contract partners, ensuring thorough root cause analysis, robust corrective and preventive actions (CAPA), and aligned decision-making impacting product quality and disposition.
• Applies Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing and QC operations.
• Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
• May participate in the development of training programs regarding all aspects of producing quality products.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
• May assist or lead compliance audits as required.
• May interface with regulatory agencies as required.

Compliance, Audits & Inspections

• Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas to support continuous improvement.
• Support during regulatory inspections and internal audits.
• Monitor regulatory requirements and proactively assess potential operational compliance risks.

Quality Systems & Documentation

• Approve GMP documentation including risk assessments, procedures, master batch records, specifications, and analytical methods.
• Drive continuous improvement of quality processes supporting GMP operations.

Leadership & Collaboration

• Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
• Partner cross-functionally with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.
• Lead or support Quality-related operational projects and improvement initiatives.
• Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
• Use risk-based decision making to prioritize tasks and ensure product quality.
• Maintain strong working knowledge of Health Canada, FDA, and global GMP expectations.

Knowledge

• Proficient in GMPs and/or GLPs.
• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Has proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge and good proficiency in Microsoft Office applications.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
• Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

Specific Education & Experience Requirements

• 6+ years of relevant experience in a GMP environment related field and a BS or BA OR 4+ years of relevant experience and a MS.
• Hands-on experience supporting biologics, GMP Manufacturing and QC operations is required.
• Strong understanding and experience of materials management, manufacturing and analytical methods and testing systems within a GMP environment.
• Strong cross-functional collaboration and communication skills are required.