Therapeutic Area Strategy Executive Director for Oncology & Hematology at Novartis, supporting strategy creation and providing commercial insights for early - phase projects.
About the role
- CQV Associate Director overseeing multiple CQV projects and providing subject matter expertise. Building client relationships and supporting strategic project engagements in life sciences.
Responsibilities
- Acts as a recognized subject matter expert (SME) in CQV across multiple sites and projects.
- Provides high-level consulting on best-in-class CQV practices, including risk-based approaches and program assessments.
- Supports strategic project work as a door-opener or specialized expert.
- Reports directly to the CQV Global Director and serves as a knowledge resource internally and externally.
- Manages client relationships across multiple sites or projects.
- Participates in or leads the initiation and early stages of billable CQV projects.
- Oversees internal programs with cross-functional teams, including client personnel and contractors.
- Drafts and reviews CQV proposals and estimates for clients.
- Engages in forums, publishes articles, participates in committees, and influences guidance standards.
- Builds and maintains a network of industry contacts to identify new opportunities and increase value to current clients.
- Supports the proposal process and helps grow CAI's business pipeline.
- Mentors employees and develops qualification and training materials.
- Acts as an internal CQV knowledge base for teams across the globe.
- Contributes to internal qualifications, knowledge sharing, and process improvements.
- Advises on integrated commissioning and qualification strategies.
- Implements QRM methodologies and assesses supplier qualifications.
- Consults on facility, equipment, utility CQV methods, including automation integration.
- Supports digital validation life cycle and strategies for accelerating project delivery and speed to market.
Requirements
- BS or MS in a relevant science or engineering field, or equivalent
- Seven (7) or more years in CQV SME or project manager for large CQV projects roles for life sciences. Demonstrated success in leading your team to achieve defined goals.
- Excellent oral and written communication skills in English
- Excellent skill in leading teams to perform complex tasks under pressure.
- Excellent problem-solving skills
- Customer-service focused.
- Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
- Able to travel domestically and internationally will be required. There will be significant travel to the US as part of this role.
Benefits
- We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
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