Career Connections Canada Inc
"Connecting great people with great companies"
The Senior Manager will ensure that all activities are kept compliant. This position will also analyze Regulatory Intelligence from all locations authorities and share information to ensure that all sites are aligned in terms of process and systems in line with pharmaceuticals cGMP requirements. This position will also ensure that appropriate Quality agreements are available for each relevant relationship that involves our company.
Principal Duties and Responsibilities:
- Ensure that FAR are submitted in time from USA
- Ensure that USA recalls management is efficient and compliant
- Ensure that USA customer complaints management is efficient and compliant
- Report to all locations on new compliance initiatives and regulations from Regulatory authorities (quality intelligence)
- Drive the Global Quality Escalation/Recall Committee
- Coordinate to Quality agreement review and approvals for the external CMO
- Support the Quality Compliance needs during Business Development
- Coordinate the CAPA interface
- Help site in the maintenance of establishment license, NHP license, MOH license, site master file and any other regulatory compliance requirements
- Act as Subject matter expert
- Support and participate in Regulatory audits and customer’s audits as needed
- Develop SOPs as required
Background and Experience:
- Minimum of B.Sc. Chemistry or associated field
- Multi-year experience (minimum 10 years) at the supervisory/management level in the pharmaceutical industry
- Experience in pharmaceutical manufacturing
- Strong demonstrated leadership
* Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.