Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation.
Plans, drafts, reviews and delivers outputs from quality governance forums including escalations, decisions, annual reports and other documentation as well as coordinate, prioritize and sequence quality governance topics.
Directs GCP quality governance metrics and assessment of GCP quality governance effectiveness and efficiency.
Collects and reports data to support assessment of compliance to process, trends, and common issues with a view towards overall impact and continuous improvement
Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion.
Execution and oversight of the periodic review of GCP quality governance forum remit, charter, scope, membership.
Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training.

Bachelor’s Degree or equivalent experience a must
5+ years of related pharmaceutical and/or quality experience
A robust understanding of research and development and GCP
Project or role-based experience in policy and standards, process management and reporting, and change management/adoption
High energy and drive for organization and execution
Excellent verbal and written communication skills; must be able to interact effectively with professionals at all levels and communicate recommendations with diplomacy and tact
Strong project management skills, with experience managing time sensitive projects
Ability to prioritize and demonstrates strong organizational skills and the ability to manage multiple tasks and projects simultaneously
Advanced skills in all common O365 applications and other reporting tools
Experience with project management, process tracking or other workflow tools.

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Governance Quality Operations Lead

Key skills