North York, Ontario

Technical Quality Manager II (Engineering) SNFIJP00003051

Technical Manager- Product Quality
Toronto

Description
The position is responsible for Agency Lot Release Protocol preparation. This person's role is vital as independent quality review of critical manufacturing and test data to assure the consistent quality of each manufactured lot before it is submitted to Agencies

Lot Release Protocols (90%): Populate, review and publish
Lot Release Protocols for submission to regulatory agencies ensuring right first time accuracy throughout the process.
Support the preparation of responses to lot release queries from regulatory agencies in a timely manner.

Quality Systems & Projects (10%):
Maintain training to perform the designated cGMP activities and meet Health Safety and Environment requirements.

Support maintaining Quality Systems (e.g. deviation, CAPAs, change controls, audits and inspections).
Collaborate with sites and support projects that improve safety, quality, delivery, cost, involvement and strategic priorities. Support Quality Initiatives for process improvement.
 

An independent quality review of critical manufacturing and test data for each lot of vaccines is essential to assure the consistent quality of each manufactured lot before it is marketed. Escalation to Senior Management on quality events, resolution of conflicts and propose recommendations. Participation in self-inspections and Regulatory Inspections.

Excellent interpersonal and negotiation skills are critical as the position requires extensive interaction with both internal and external customers. The position is considered stressful due to the need to meet critical timelines for both internal customers and regulatory agencies.
In addition, the incumbent will be responsible for their development, training and performance assessment of priorities and associated competencies agreed with management.
Bachelors of Science Degree and/or at least 8 years pharmaceutical cGMP experience (for US, Canada, Europe and International) with related Quality Batch Disposition (Release and Reject) or similar related certification and experience.
Strong background in all stages of biological product manufacturing
Excellent report writing and communication skills; demonstrated managerial skills and good judgement. Excellent interpersonal and negotiation skills are critical as the position requires extensive interaction with both internal and external customer
 
Strong knowledge and understanding of Quality and current Good Manufacturing Practices Exhibit strong scientific and analytical understanding of the processes and quality systems
Competence in systematically solving problems using appropriate process improvement methodologies to analyze complex data / information from different cross-functional teams, both locally and globally. Balanced Judgment / Risk Analysis