Quality Operations Lead for DS & DP

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 150,000 - 230,000; Full time

Job summary

WUXI XDC Singapore Private Limited is seeking a Senior Manager, Quality Operations to provide strategic leadership for DS/DP manufacturing quality. You will oversee batch disposition, material release, deviations, investigations, CAPAs, change controls, QRM, NPI, and ensure GMP compliance across shifts.

You will establish an effective QA support model, make independent quality decisions, support Manufacturing during operations, and lead NPI, technology transfer, and validation efforts while

Qualifications

• Bachelor's degree in a life sciences or related field.
• Minimum 10 years pharma/biotech/CDMO GMP experience.
• Minimum 5 years leadership in Quality Operations.
• Strong batch disposition, deviations, CAPA, change control experience.
• Experience with regulatory inspections and customer audits.

Responsibilities

• Provide quality oversight for DS and DP manufacturing operations.
• Establish QA support model for oversight, escalation, and decision-making.
• Lead review and approval of batch records, investigations, deviations, CAPAs, QA docs.
• Make independent quality decisions to support operations.
• Support manufacturing during shift operations and deviation resolution.
• Act as Quality Lead for NPI, tech transfer, process validation, and commercial readiness.
• Ensure SOPs and quality records comply with FDA/EU PIC/S ICH standards.
• Audit and inspection readiness participation.
• Collaborate with Manufacturing, QC, Engineering, Supply Chain, and global teams.
• Drive continuous improvement and quality culture.
• Develop resource plans and on-call strategies for Quality Operations.

Skills

Quality leadership

GMP compliance

Batch disposition

CAPA & investigations

Data integrity

Regulatory inspections

Education

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

Job description

WUXI XDC Singapore Private Limited is seeking a Senior Manager, Quality Operations to provide strategic leadership for DS/DP manufacturing quality. You will oversee batch disposition, material release, deviations, investigations, CAPAs, change controls, QRM, NPI, and ensure GMP compliance across shifts.

You will establish an effective QA support model, make independent quality decisions, support Manufacturing during operations, and lead NPI, technology transfer, and validation efforts while