What You'll Do:
- Manage end-to-end Quality Control project timelines, supporting activities such as method validation, PPQ Β (Process Validation) readiness.
- Coordinate cross-functional QC and QA activities to ensure key milestones are met and projects remain on schedule.
- Partner closely with QC laboratory teams, QA, and manufacturing stakeholders to align project deliverables with validation and regulatory timelines.
- Identify risks, dependencies, and potential delays and escalating as needed.
- Facilitate team and cross-functional meetings, including agenda preparation, documentation of meeting minutes, and tracking of action items.
- Ensure effective communication and information flow between QC, QA, manufacturing, and other internal stakeholders.
- Support preparation of project documentation and internal reporting materials such as project timelines, Gantt charts, and status presentations for leadership updates.
- Coordinate with internal teams and external partners/vendors to ensure alignment on testing timelines and deliverables.
- Assist with activities to prepare QC operations and laboratories for GMP readiness and PPQ testing support.
About You
- Bachelorβs degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field).
- 5+ years of relevant experience, including: Experience working in or closely supporting a QC laboratory environment and project management or project coordination experience within pharmaceutical, biotech, or life sciences.
- Strong understanding of QC laboratory workflows, including analytical testing, method validation, and support of process validation activities.
- Familiarity with GMP environments and requirements for analytical testing supporting manufacturing.
- Proven ability to manage complex timelines, coordinate multiple stakeholders, and track project deliverables.
- Strong organizational and communication skills with the ability to manage multiple priorities simultaneously.
- Proficiency with Microsoft Office tools (Excel, PowerPoint, Word) and experience using project management tools such as Microsoft Project or similar timeline tracking systems.
- Experience working with cross-functional teams and external vendors.
- Laboratory background and prior hands-on lab experience.
- Ability to travel occasionally for project-related work if required.
Β