Essential Responsibilities: - Leading and managing multiple new product development projects withinthe Core Imaging R&D portfolio to agreed specifications and qualitywith the approved budget and resources
- Working closely with all cross-functional groups in delivering theproject(s).
- Leading all cross-functional project activities.
- Ensuring, with input and support from line functions, full compliancewith all applicable laws, legislation and regulatory requirements e.g.GLP, GMP and GCP.
- Managing global program resources, quality objectives, regulatoryrequirements, schedules, and program risks and making decisions based onbusiness objectives
- Aware of and comply with the GEHC Quality Manual, Quality ManagementSystem, Quality Management Policy, Quality Goals, and applicable lawsand regulations as they apply to this job type/position – GLP, GMP, GCP
- Complete all planned Quality & Compliance training within thedefined deadlines
- Identify and report any quality or compliance concerns and takeimmediate corrective action as required
- Drive compliance/closure of Regulatory and Quality requirements beforeapproving project milestones
- Identify continuous improvement activities by initiating theimplementation of process and product quality improvement initiatives Qualifications/Requirements: 1. PhD in life sciences, or equivalent(defined as BS/MS Degree in life sciences, with a minimum of 5-8 yearsrelevant work experience in the area of Pharmaceutical development)
2. >5 years relevant project leadership experience in the area ofpharmaceutical and or clinical development.
3. Demonstrated leadership of cross-functional project teams and anability to drive project plans to completion
4. Familiarity with the submission process to CFDA/PMDA and otherregulatory standards and guidelines e.g. FDA and EMEA
5. Demonstrated success in building and leading collaborative global andcross-functional teams and relationships
6. Demonstrated facilitation and negotiation skills in driving closureon product/project related decisions/issues