SR SPECIALIST, DEVELOPMENT SUPPLY QUALITY

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
As part of the Development Quality Team you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. Support key process/system improvements in collaboration with Development, Regulatory and Safety functions, Development Quality peers, and other Quality colleagues. You will provide quality oversight and support to the Global Clinical supply (PDCS) team in ensuring compliance with GMP (good manufacturing practices) for product distribution and GCP (good clinical practices) in the supply of product to the clinical sites.

• Quality support to the PDCS team to ensure on time delivery of safe and compliant product for clinical trials associated with the management of temperature excursions.
• Works with the PDCS team to ensure on time commitments for quality oversight linked to risk management, change control implementation, deviation/investigation review, and associated CAPAs.
• Ensures Quality support and review of procedures associated but not limited to ISR (investigator sponsor research), comparators and home dosing.
• Quality oversight and approval of the pharmacy manuals, IRT protocol approval and build verification, SOP review and approval.
• Quality review of technical and quality agreements with clinical trial partners.
• Supports quality issues including audit related CAPAs, quality issues/incidents CAPA development, working closely with the audit team, Development, Regulatory and Safety functional lines along with PDCS.