Senior Quality Lead (Pharmacovigilance)
Our PDQ Vision
In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivalled transparency with health authorities, patients and society. Our work provides leadership, know how and partnering on quality across Products, Pharma affiliates and global regulated processes.
From (non)/clinical studies to post marketing pharmacovigilance, we make sure that we're doing it right, so that patients can trust.
We are looking for experienced quality professionals to join our Roche PDQ team who bring PV technical experience, are able to apply their critical and strategic thinking, and who have the ability to negotiate with and influence key stakeholders with self assurance.
The PDQ PV Strategy Portfolio Lead is responsible for the determination of the QA positions within the PV area of the PDQ Strategy portfolio
A day in the life:
- Deliver the PDQ Strategy in assigned PV area through defined QA positions aimed at ensuring successful Health Authority engagement, including getting prepared for and hosting/supporting inspections
- Connect with internal PDQ and external stakeholders and seek to understand and evaluate their priorities, develop the frequency and how best to check-in to stay on top of changes, which then inform your strategy
- Continuously determine the prioritised PDQ activities (to include but not limited to; QA programs, training focus, process improvement, Affiliate visit focus, data analytics) which requires the delivery of evidence against the defined QA positions
- Synthesize the results of this evidence against the stated target positions (spending time with the PDQ staff delivering the strategy for your area, understanding their outcomes and building this into the narrative of your positions)
- Deliver regular engaging and informative reports on the status and actions of the QA positions for the PV strategy area (to enable company reporting, internal governance committee status updates and health authority engagements as required for the Global Strategy Head)
- Lead or join communities of interest/knowledge/practice for your area of the strategy, contribute to the learning of PDQ via these communities
- Support PDQ colleagues in prioritised activities delivering the evidence for the PV strategic area, help navigate ongoing challenges
Professional and Technical Requirements Education/Qualifications:
- Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience
- Advanced degree preferred minimum
- Minimum 7 years in pharmaceutical industry and/or quality assurance
- Minimum 5 years in PV related discipline
- Demonstrated applied knowledge of pharmacovigilance and regulatory requirements, as well as analytical, organizational and planning skills
- Project management experience with proven leadership, mentoring and coaching desired
- Proficiency in the conduct of audits
- Experience supporting regulatory authority inspections
- Ability to formulate clear business questions that can be answered with data
- Proficiency in utilizing data and visualisation tools to generate insights
If you are interested in the Strategy Role please apply today.