Our client, a global healthcare leader dedicated to the development and commercialization of products to respond to unmet medical needs, have asked Bryan Forrest of Lock Search Group to assist them in their search for a Pharmaceutical Director to join their team in Toronto, ON. This is a great opportunity to join a global multi-national company building out their Toronto hub.
The Pharmaceutical Director is responsible for leading and directing all aspects of Quality and Pharmaceutical Supply, Regulatory Affairs, and PV (externally managed) primarily for the Canadian and US markets.
- Oversee/manage internal team executing on pharmaceutical supply and quality, and regulatory affairs activities; oversee/ manage external consultants in Canada, US and Japan for PV activities.
- Direct and support manufacturing, packaging, labeling, and distribution activities including supporting supplier issue resolution, audits and regulatory authority inspections for all products marketed to ensure continuous product supply. Manages recall activities as required.
- Collaborates with global stakeholders to ensure Quality oversight and compliance with Health Canada, FDA, and corporate policies / guidelines.
- Ensures all necessary Quality System Documents (e.g. SOPs, Quality Agreements and any other) required for meeting compliance requirements are in place. Authors/revises Quality System Documents, as necessary.
- Keeps abreast of developments and changes in regulations, policies and guidelines and industry practices, assesses their impact on business and provides proactive guidance to management to drive continued success.
- Manages ongoing personnel and hires additional personnel when required to support overall business activities.
- BSc. / MSc. / PhD. in chemistry/microbiology/biochemistry (or related life science field) with 10+ years of diverse experience in pharmaceutical operations with at least 5+ years’ practical experience in a leadership position.
- Functional knowledge of GMPs and applicable Health Canada, FDA, and global guidelines; proven track record of successful filings to Health Canada and FDA.
- Ability to see beyond own function to understand business issues and implement best practices.
- Demonstrated hands-on technical leadership with excellent problem-solving and troubleshooting skills.
- Strong coaching skills exemplified by track record of developing teams and individuals.
- Outstanding project planning, communication (verbal and written) and relationship skills (internal and external).
To apply, please submit your resume using the "Apply Now" button, or contact Bryan Forrest directly at email@example.com
We thank all interested applicants, however only those chosen for an interview will be contacted.