Senior QA Operations Leader – Drug Substance & Product

WuXi XDC; Singapore; Vor Ort; SGD 180.000 - 240.000; Vollzeit

Zusammenfassung

WuXi XDC is seeking a Senior Manager, Quality Operations in Singapore to lead quality oversight for Drug Substance (DS) and Drug Product (DP) manufacturing. This role requires strategic leadership over batch disposition, material release, deviations, investigations, CAPAs, change controls, and QA support across shifts while ensuring compliance with FDA, EU GMP, PIC/S GMP, and ICH guidelines.

The incumbent will establish an effective QA support model, lead quality decisions on product quality and

Qualifikationen

• Bachelor's degree or higher in Life Sciences or related field.
• Minimum 10 years in pharmaceutical/biotech GMP environments.
• Minimum 5 years in leadership roles managing Quality Operations or related quality functions.
• Strong knowledge of batch disposition, deviations, investigations, CAPAs, change control, and GMP manufacturing support.

Aufgaben

• Provide strategic leadership for Quality Operations supporting DS and DP manufacturing across routine and shift operations.
• Lead review and approval of batch records, investigations, deviations, CAPAs, change controls, and GMP documentation.
• Make independent quality decisions on product quality, batch disposition, material release, and manufacturing events.
• Lead NPI, tech transfer, process validation, and commercial readiness activities.
• Ensure compliance with FDA, EU GMP, PIC/S GMP, ICH guidelines, and data integrity principles.

Kenntnisse

Leadership

Quality decision-making

Stakeholder management

Communication skills

Ausbildung

Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or related discipline

Jobbeschreibung

WuXi XDC is seeking a Senior Manager, Quality Operations in Singapore to lead quality oversight for Drug Substance (DS) and Drug Product (DP) manufacturing. This role requires strategic leadership over batch disposition, material release, deviations, investigations, CAPAs, change controls, and QA support across shifts while ensuring compliance with FDA, EU GMP, PIC/S GMP, and ICH guidelines.

The incumbent will establish an effective QA support model, lead quality decisions on product quality and