Senior QC Leader: GMP Excellence & Regulatory Readiness

Discover International; Emilia-Romagna; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Discover International is seeking a Senior QC Manager for our Parma, Italy site to lead and expand the Quality Control function during a pivotal phase as the site prepares for FDA approval of a new drug. The role requires strategic leadership across QA, Manufacturing and Regulatory teams to ensure GMP compliance and robust QC performance.

The successful candidate will drive quality transformation, oversee a large QC organization, and partner with cross-functional teams to anticipate issues,

Competenze

• Extensive experience in Quality Control within a GMP pharmaceutical manufacturing environment.
• Significant people leadership and organisational management experience.
• Strong understanding of how QC interacts with QA, Manufacturing, Regulatory and other technical functions.
• Experience supporting or leading FDA and/or European regulatory inspections.
• Strong ability to assess quality criticality, risk and escalation, particularly across different products and manufacturing processes.
• Excellent communication and stakeholder-management skills, with the ability to influence senior leaders and cross-functional teams.
• Experience driving quality transformation, process improvement and organisational change.

Mansioni

• Lead and develop the Quality Control organisation, providing both professional and operational leadership.
• Oversee QC activities across the site, ensuring high standards of GMP compliance, product quality and laboratory performance.
• Lead and develop a large QC organisation, driving accountability, technical excellence and continuous improvement.
• Support FDA and other regulatory inspections, ensuring the QC function is inspection-ready and able to respond effectively to regulatory requirements.
• Drive quality improvements and organisational change as part of a broader renovation and development of the Quality organisation.
• Work closely with QA, Manufacturing, Regulatory Affairs, R&D and other functions to identify risks, anticipate quality issues and ensure effective escalation.
• Develop a more proactive approach to quality, ensuring critical issues are identified early and appropriately managed.
• Support the introduction of new processes and ways of working across the site.
• Act as a senior QC representative in cross-functional and strategic discussions.
• Ensure effective management of quality risks across different departments, products and manufacturing processes.

Conoscenze

Quality Control leadership

GMP compliance

Cross-functional collaboration

Regulatory inspections

Risk assessment

Process improvement

Stakeholder management

Descrizione del lavoro

Discover International is seeking a Senior QC Manager for our Parma, Italy site to lead and expand the Quality Control function during a pivotal phase as the site prepares for FDA approval of a new drug. The role requires strategic leadership across QA, Manufacturing and Regulatory teams to ensure GMP compliance and robust QC performance.

The successful candidate will drive quality transformation, oversee a large QC organization, and partner with cross-functional teams to anticipate issues,