Career Connections Canada Inc.
"Connecting great people with great companies"
Our pharmaceutical client in Brampton is presently looking for a Director, Quality Compliance (QA) to join their team.
This position is responsible for leading the Regulatory Compliance Program for North America and assures products are manufactured, inspected, tested and packaged according to GMP and Company requirements. This is done on a day-by-day basis by performing prevention, detection and corrective activities that will assure that marketed product will meet the current processing parameters, specification and expiration dating for continued production and distribution.
The position is responsible for the oversight of the Vendor Management Program and North American Contract Manufacturing Operation (CMO) compliance.
The position is also responsible for the oversight of Site R&D GMP Compliance.
Principal Duties and Responsibilities :
- Provide leadership to team through employee development and performance management as well as establishing a culture of Quality.
- Report on new compliance initiatives and regulations from Regulatory authorities.
- Act as the main contact for Canada and US for Regulatory Inspections and Market Action activities.
- Coordinate and Lead the inspection readiness program including the self-inspection program.
- Prepare and host all Regulatory audits and Customer’s audits of the Canadian manufacturing facility and oversee the inspection activity involving US Quality Compliance.
- Ensure oversight and management of US Quality Compliance, inclusive of FAR and Recall management, CMO oversight and Quality Agreements.
- Provide leadership and support to the self- inspection program.
- Provide leadership and support for the vendor management program.
- Ensure that the level of non-conformance investigations are sufficient to ensure appropriate CAPA and prevention of recurrence.
- Support critical & recurrent major deviation’s investigation.
- Ensure that process are in place to support identification, closure and effectiveness checks of CAPA or remediation activities.
- Coordinate and Lead recalls as needed.
- Manage Customer quality requirements e.g. Specifications, Quality Agreements, product portfolios.
- Ensure that the audit program is robust and compliant to regulatory expectations.
- Coordinate and prepare the Site Quality Council, the Site & Global Recall Assessment Committees and the Cross Functional/Site Risk Forum.
- Maintain establishment of licenses, NHP license, Site Master File and any other regulatory compliance requirements.
- Act as Compliance subject matter expert.
- Maintain Industry Quality Intelligence and align compliance policies as needed
- Ensure harmonization of processes and best practice of Quality Compliance between Canada, US and Israel.
- Develop SOPs as required.
- Back up Senior Director, QA and Compliance, North America as required.
- Other duties as assigned.
Knowledge, Skills and Abilities
- Experience in dealing directly with Regulatory Agency officials (Health Canada, USFDA) including market actions.
- Minimum of B.Sc. Chemistry or other associated field.
- Minimum 15 years at the supervisory/management level in the pharmaceutical industry.
- Experience in pharmaceutical risk management.
- Project management skills.
- Complete knowledge of pharmaceutical operations including USFDA environment.
- Complete knowledge of GMP, FDA, HPFBI and their associated guidelines.
- Good organizational skills and multi-tasking ability.
- Excellent written and verbal skills.
- Good interpersonal skills.
- Knowledge of validation is preferred.
- Non-routine and complex problems
- Difficult contacts with Regulatory Agencies
- Problems associated with production issues that could range from scheduling problems to errors in production
- Non-compliance investigations
- Mitigation of customer, vendor and regulatory audit issues
***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.