About this role:
We’re hiring a Quality Manager for a 1-year contract with one of our clients, a global pharmaceutical company located in Toronto. This is a remote position.
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 company 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.
What you need to bring:
- 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 customers;
- Exceptional organizational skills. Ability to work within critical timelines;
- 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;
- Effective Communication;
- Good interpersonal, project management and facilitation skills required.
Why work through Brunel? We start with competitive rates, a comprehensive benefits package and a safe on-boarding process. With our industry insights and recruiter expertise, we are supporting projects and clients worldwide. With Brunel you gain experience and expertise, building on your skills and developing your career further.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services. Join us today.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use this number:
Brunel Canada - Calgary
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