Genomadix
Kanata, ON
Posté aujourd'hui
Détails de l'emploi :
Télétravail
90 000 $ / année
Temps plein
Gestion
Project Manager / Senior Project Manager
Location: Canada (remote) or Ottawa, ON (hybrid), Eastern and Central time zones preferred
Employment Type: Full-Time, Permanent
Travel: Occasional, minimal
Position Summary
Genomadix is seeking a Project Manager or Senior Project Manager to lead cross-functional projects across the organization. This role will manage R&D development programs and manufacturing transfers and will also support broader company initiatives spanning multiple functions. The level of the role will be determined based on the successful candidate's experience.
Key Responsibilities
Lead medical device projects from R&D development through design transfer and manufacturing transfer.
Plan and execute manufacturing transfers in coordination with Operations, Quality, Supply Chain, and Regulatory.
Partner with R&D to manage development timelines, milestones, and phase-gate reviews.
Manage company-wide projects across functions including Quality, Regulatory, Commercial, Customer Success, and Finance.
Build and maintain project plans, schedules, budgets, risk registers, and status reports.
Coordinate with external partners and suppliers, including Asia-based projects that require early-morning meetings.
Identify risks and dependencies early, and drive mitigation and escalation.
Ensure project work complies with applicable regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820, Health Canada, IVDR).
Communicate progress, issues, and decisions clearly to team members and leadership.
Required Qualifications
Minimum 5 years of project management experience within a medical device PMO environment.
Demonstrated experience supporting manufacturing transfers and R&D product development.
Experience managing cross-functional projects across a variety of business functions.
Working knowledge of design controls, change control, and quality management systems.
Proficiency with project management tools and methodologies (e.g., MS Project, Smartsheet; Waterfall, Agile, or hybrid).
Strong communication, organizational, and stakeholder management skills.
Bachelor's degree in Engineering, Life Sciences, Business, or a related field.
Available for regular early-morning meetings to support Asia-based projects.
Able to travel occasionally.
Preferred Qualifications
In vitro diagnostics (IVD) experience; pharmacogenetics or molecular diagnostics a strong asset.
PMP or equivalent project management certification.
Experience working with contract manufacturers.
Familiarity with FDA 510(k)/De Novo, Health Canada medical device licensing, or IVDR.
Experience working in a small or growing company.
Partager un emploi :
Foire aux questions
This role can be remote in Canada or hybrid in Ottawa, ON, with Eastern and Central time zones preferred.
This is a full-time, permanent position with occasional, minimal travel.
You will lead medical device projects from R&D development through design transfer and manufacturing transfer, plan manufacturing transfers, manage cross-functional projects, and build project plans, schedules, budgets, and risk registers.
Minimum 5 years of project management in a medical device PMO, experience with manufacturing transfers and R&D development, cross-functional project management, knowledge of design controls and quality systems, and a bachelor's degree in a related field.
The role requires ensuring project work complies with standards such as ISO 13485, FDA 21 CFR Part 820, Health Canada, and IVDR.
Preferred qualifications include IVD experience, PMP certification, experience with contract manufacturers, knowledge of FDA 510(k)/De Novo, Health Canada licensing, or IVDR, and experience in a small or growing company.
