Job Expired
This posting has expired and applications are no longer being received and this job does not show up on the main job list.
This posting has expired and applications are no longer being received and this job does not show up on the main job list.
| Position Type: | Full-time |
| Location: | London, ON |
| Date Posted: | Dec 13, 2022 |
Job Description
Director, Quality Assurance and Compliance
Reporting to the President & CEO, the Director will provide leadership and expertise related to quality assurance and compliance functions for all products imported, manufactured and distributed by ANVO. This position serves as a key member of the quality leadership team to drive overall quality management and delivery of ANVO’s corporate strategies and objectives.
Responsibilities:
- Oversee quality assurance and compliance functions while providing expertise in handling product releases, customer complaints, deviation investigations, product defects analysis, process improvement, change control, and regulatory compliance of all products.
- Responsible for the release of product lots imported for distribution by ANVO
- Ensuring the timely sampling/testing arrangement, technical review of technical documentation and carrying out investigations prior to lot release for distribution.
- Responsible for the implementation and maintenance of Quality Systems; Change Control, Deviations, Supplier Quality CAPA
- Provide technical support in conducting investigation of deviations and failures and influence global suppliers with respect to quality, compliance or investigational events
- Propose and recommend corrective actions preventive actions and review and approve related documentation.
- Responsible for metrics and KPI development and reporting
- Ensure quality and optimal tool implementation, ie. electronic quality management system.
- Establish and negotiate quality agreements with new suppliers as required
- Coordinate, manage, and conduct supplier surveillance audits
- Perform third party GMP audits of Contract Testing Labs, Manufacturing and Labelling/Packaging facilities including providing recommendations, write audit reports and follow up with the audit report and response.
- Oversight of the self-inspection program, GMP document retention, annual product review and customer complaint processes
- Lead the QA and Compliance teams and provide training and coaching to team members
- Provide technical know-how during the purchasing of new tools ie. software and provide sound advice when introducing state of the art technologies
- Keep abreast of any changes in technical guidelines, cGMP and USP/EP and ensure timely implementation of these changes
Required Skills & Qualifications:
- B.Sc. or M.Sc. or in Chemistry, Biology or equivalent
- Minimum 10 years related experience within pharmaceutical industry
- Strong leadership in Quality Assurance, Systems and Compliance
- A strong understanding of Canadian and US Good Manufacturing Practices and Guidelines
- Understanding and experience with controlled substances is an asset
- Background in Microbiology is an asset
- Experience with statistical tools in designing experiments will be an added advantage
- Good communication (written & verbal), interpersonal, and organization skills
- Ability to work independently and as part of a team.
Applicants can submit resumes to info@anvopharma.com