The Molecule Strategy Portfolio Lead plays an essential role in
- Bringing safe medicines to our patients faster by defining, generating and leveraging quality evidence for Molecules, underpinned by an aligned data strategy.
- Providing Health Authorities with confidence in our data and patient protection that enables a smooth and rapid approval of our medicines.
The Molecule Strategy team works across the enterprise, on Late Stage Therapeutic Area; in the GCP and GLP Early Development space, and with those Service Providers contributing to Roche Clinical Trials.
Primary Responsibilities and Accountabilities:
- Focus on early development projects, both in GCP and GLP.
- Responsible for the determination of the Quality Positions for the molecule pipeline/ Service Providers supporting clinical trials.
- Focus on the issues that matter.
- Assess the status of Impact Factors, the areas that enable a program to thrive or potentially, could impair/ derail it, namely, for patient/human subject protection.
- Deliver the PDQ Strategy in assigned enterprise/therapeutic area through defined QA Positions
- Develop, maintain and implement a Quality Narrative by synthesizing the results of evidence of quality assurance activities on Roche Quality Positions across high priority molecules in the pipeline.
- Deliver regular engaging and informative reports on the status and actions of the QA positions for the assigned strategy area to enable company reporting, internal governance committee status updates and health authority engagements
- Ensure successful Health Authority engagement, including
- Sharing of Quality Narratives to Health Authorities
- Preparing for and managing inspections
- Hosting and supporting inspections
- Ensure appropriate capa is in place
- Establish strong partnership/relationship with business stakeholders
- Seek to understand and evaluate their priorities
- Actively participate in and make meaningful contributions and propose solutions
- Consider how best to check-in to stay on top of changes, which then inform your strategy
- Continuously assess and determine the prioritized PDQ activities
- Deliver regular engaging and informative reports on the status and actions of the QA positions for the assigned strategy area (to enable company reporting, internal governance committee status updates and health authority engagements as required for the Global Strategy Head)
- Masters, Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience
- Advanced degree in referenced fields preferred
- Minimum Requirements
- Minimum 7 years in pharmaceutical industry and/or quality assurance
- Minimum 5 years in GCP/GLP related discipline
- Demonstrated applied knowledge of clinical and regulatory requirements, as well as analytical, organizational and planning skills
- Proficiency in GLP/GCP regulations
- Experience supporting regulatory authority inspections
- Strategic thinking with ability to influence
- Ability to formulate clear business questions that can be answered with data
- Proficiency in utilizing data and visualization tools to generate insights
- Ability to see the big picture while attend to the essential details
- Problem solving skills
- Ability to establish strong collaborative relationships with a broad community of stakeholders across the business
- Strong verbal and written interpersonal and communication skills.
Roche is an equal opportunity employer.Research & Development, Research & Development > Drug Safety