Quality Systems Manager
1 week ago
We are seeking a Quality Systems Manager to join our team at Endo International. This is an exciting opportunity for a highly skilled professional to lead quality systems and ensure compliance with regulatory requirements.
About the RoleAs a Quality Systems Manager, you will be responsible for providing leadership and guidance on quality systems, including change control, deviations, investigations, complaints, and CAPA systems. You will also supervise QA batch release functions for commercial and distribution activities.
You will work closely with cross-functional departments and suppliers to complete documentation related to our quality systems and batch release. Your role will involve ensuring compliance with current domestic and international GMPs and regulatory agencies.
Key Responsibilities- Contribute to the development, management, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards.
- Assist with all aspects of quality systems, including Change Control, Deviations, Investigations, complaints, and CAPA systems to assure compliance and timely and accurate completion of reported events.
- Supervise the QA batch release functions for cGMP commercial and distribution activities from the contract manufacturing, filling, testing, and packaging facilities.
- Prepare and/or review controlled documents (e.g. SOPs) required for compliance.
To be successful in this role, you will need:
- A Bachelor's degree in a health-related discipline or science.
- 5+ years' experience working in a Quality role in a GXP environment in the pharmaceutical or medical device industry.
- 2+ years of experience with quality management systems.
- Thorough understanding of fundamental GXP/ISO 13485 terminology, concepts, regulations, and industry standards.
- Thorough understanding of quality systems and associated regulatory requirements and their application.
- Ability to identify and troubleshoot routine technical problems.
- Bilingual (French and English) with excellent oral and written communication skills in both languages.
We offer a competitive salary range of $90,000-$120,000 per year, depending on experience, as well as a comprehensive benefits package, including hybrid work schedule, benefits package on first day, retirement savings plan, employer contribution to employee RRSP, employee assistance program, telemedicine program, employee referral program, free gym on site, and free parking.
We are committed to diversity, equity, and inclusion and actively promote a culture that values each person's unique perspective. If you are a motivated and experienced Quality professional looking for a new challenge, please submit your application.
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