
Project Manager
3 days ago
Let's talk about Responsibilities
Aligning Quality & Regulatory outcomes
Lead cross-functional teams to plan, execute, and deliver high-impact projects within established timelines, resources, and budgets
Support quality and regulatory discussions across program (e.g : ERP transformation program).
Work closely with internal / external stakeholders, assist GPO (Global Process Owner), key team members and SMES in achieving shared goals.
Help ensure program activities meet quality and regulatory standards.
Organize QARA meetings to align stakeholders and drive consensus.
Ensure harmonization of QMS & Quality practices across all participating countries or sites
Support creation or update of Standard Operating Procedure (SOP) as and when required
Communication & Stakeholder Engagement
Ability to lead cross-functional teams, manage multiple projects, and communicate effectively at all levels.
Team Collaboration
Coordinate with teams in different countries and time zones.
Promote integration between QARA and other departments like IT and operations.
Risk & Compliance
Proactively identify, assess, and mitigate risks in alignment with QARA and program requirements
Technical Support
Contribute to software implementation projects, including support for Computer System Validation (CSV), requirements traceability, and user acceptance testing (UAT).
Actively participate in the Oracle Fusion implementation as a QARA representative.
Change Management
Lead or support system and process changes.
Help the change management champion and promote a culture that adapts well to change.
Continuous Improvement
Suggest ways to improve quality and efficiency.
Support the creation of standardized practices and tools.
Ensure compliance with medical device regulations.
Let's talk about Qualifications and Experience
Project Management : Proven experience in project management, framework and tools within a regulated industry, ideally healthcare or medical devices.
Industry Background : Familiar with manufacturing, supply chain, and compliance.
Self-Starter : Works well independently and takes initiative.
Collaboration : Builds connections across teams and departments.
Influence : Capable of aligning stakeholders with different perspectives.
Communication : Good communication skills.
Preferred :
Bachelor's degree in science or engineering.
At least 5 years of experience in the medical device industry, e.g., ISO 13485, 21 CFR Part 820.
Project Management Professional (PMP) certification or equivalent.
Experience with Agile project management methodologies.
ERP Knowledge : Experienced with Oracle systems (E-Business Suite, Fusion).
Why Join Us?
You'll be at the heart of a global transformation that's shaping how our organization delivers value through quality and compliance. If you're ready to elevate your impact and work on something meaningful with passionate professionals, this could be your next big move.
LI-APAC
Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now
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