Senior Quality Compliance Lead: Data Integrity & Risk

Regulatory Jobs; Holly Springs (NC); In loco; USD 94.000 - 175.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation assistance

Descrizione del lavoro

Genentech in Holly Springs, North Carolina, is seeking a Senior Quality Compliance Specialist to lead QRM activities, own the Data Integrity program, and chair the Change Review Board. You will collaborate with Engineering, MSAT, Operations and Global teams to embed a risk-based quality culture.

Relocation assistance is available. The role requires extensive GxP experience and a track record of driving compliance across automated, digital, and analytical systems in a fast-paced manufacturing

Competenze

• Minimum of a scientific/technical bachelor's degree; advanced degree preferred.
• Deep knowledge of global GxP regulations and their practical application.
• Experience in leading QRM, Data Integrity or Change Control programs.

Mansioni

• Lead Quality Risk Management (QRM) activities and maintain site risk register.
• Own the Data Integrity program and ensure systems comply with regulations.
• Chair Change Review Board and drive consistent change control execution.
• Provide cross-functional quality leadership and governance across sites and functions.

Descrizione del lavoro

Genentech in Holly Springs, North Carolina, is seeking a Senior Quality Compliance Specialist to lead QRM activities, own the Data Integrity program, and chair the Change Review Board. You will collaborate with Engineering, MSAT, Operations and Global teams to embed a risk-based quality culture.

Relocation assistance is available. The role requires extensive GxP experience and a track record of driving compliance across automated, digital, and analytical systems in a fast-paced manufacturing