TRD RLT PILOT PLANT QC SUPERVISOR

Summary Coordinating QC laboratory activities, responsible to ensure compliance to cGxP and Novartis standards for topic within area of responsibility (during development, transfer, release and stability), including safety testing, monitoring and trending.
Participating to Pilot Plant build-up phase as key team member for GMP quality control laboratories, as well as support for development laboratories.
Provide guidance, support and leadership for implementation of analytical standards.
About the Role Key Responsibilities.
Ensure quality, compliance, and efficiency in team operations while aligning with site strategies.
Act as the primary contact to address and manage laboratory issues related to equipment, analysis, compliance, and operational challenges.
Plan and coordinate lab activities, ensuring timely release of materials and products, proper inventory management, and adherence to site lead times.
Create capacity plans to meet business objectives, optimize laboratory performance, and proactively ensure team compliance with HSE and operational procedures.
Oversee analytical activities, including data review, batch release, analytical method lifecycle (validation, transfer, troubleshooting), and stability studies in collaboration with the Analytical Development Team.
Maintain inspection readiness, supervise compliance with cGxP, Good Laboratory Practices (GLPs), ALCOA+ principles, and manage deviations, CAPAs, and Change Controls as required.
Lead and develop team members by monitoring training compliance, ensuring qualifications for GMP tasks, fostering a culture of engagement and accountability, and supporting talent development.
Promote a positive and motivated work environment by providing constructive feedback, coaching, and modeling cultural aspirations aligned with company values.
Essential requirements.
Master’s degree (preferred) or equivalent in Pharmacy, Chemistry, or a similar scientific field.
5+ years of experience in a similar role within a GMP-regulated laboratory environment.
Strong background in analytical laboratory operations and quality management systems, with knowledge of Good Documentation Practices and Data Integrity principles.
Experience in the nuclear medicine industry (preferred).
Highly organized, detail-oriented, and accuracy-focused with the ability to work independently as a self-starter.
Proven personal ethics, responsibility, and dedication to purpose.
Excellent written and verbal communication skills, including experience interacting professionally with external vendors or business partners.
Strong familiarity with GMP compliance and laboratory workflows.