Country Quality Head

Major accountabilities:

Your responsibilities include, but are not limited to:

• Lead the development of a cross-divisional Quality Culture with high awareness on data integrity and close collaboration with business partners within Canada ensuring a state-of-the-art Country Quality Organization is in place to best support overall business strategy.
• Establish effective Quality oversight and ensure Quality Plan is implemented in Canada (HUBs & Operations, MS) namely for batch release in compliance with Marketing Authorization, effective change control management, effective complaint management, effective Quality GxP areas.
• Lead the implementation of adequate Key Quality Indicators to monitor on an on-going basis that relevant processes are in control and compliant.
• Establish regular review and assessment of KQIs at the Country Level
• Lead the implementation of applicable Quality Standards and effective CAPA processes and ensure compliance with escalation processes in Canada
• Ensure that relevant SOPs are aligned to HA regulatory requirements.
• Deliver successful GxP regulatory inspections and internal audits in the country.
• Continuously engage in benchmarking with other industries, industry peers and actively engage proactive relationships with Health Authorities

• Lead the implementation and execution of the talent management strategy for all key positions in conjunction with other countries in the region.

What you’ll bring to the role:

Essential:

• Scientific or Technology Bachelor’s Degree (mini- mum), preferably in Chemistry, Pharmacy or Life Science. PhD desired
• At least 10 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development with a minimum of years of people management experience.
• Inspiring and developing Quality Organization in Canada, promoting agility, learning and growth.
• Strong leadership presence, with ability to effectively interact with and present to Senior Management, as well as to external audiences and health authority inspectors.
• Ability to influence key opinion leaders without hierarchical authority.
• Strong organizational awareness and business acumen (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global and matrix teams.
• Business Partner and support the Product Lifecycle and product portfolio management, ensuring agility and readiness for advanced therapies launches.
• Fluency in English (oral and written), and French (oral and written), an additional language(s) a plus.

Desirable:

• Track record of successful cross- divisional/cross-functional work with complex international and multidisciplinary teams.
• Ability to influence and drive/facilitate change across the organization.