Quality Compliance Specialist

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Wuxi XDC Singapore Private Limited is seeking a QA & Compliance professional to support planning, coordination and execution of client and regulatory inspections. The role is hands-on, focusing on audit logistics, documentation management, and cross-functional communication to sustain inspection readiness.

You will coordinate schedules, prepare documents, track action items, and assist in regulatory intelligence and remediation efforts, driving continuous improvement of audit processes across

Qualifications

• Bachelor's degree or higher in a related scientific field.
• 2-4 years' experience in QA, compliance, or regulatory roles.
• Hands-on internal auditing experience and CAPA management.

Responsibilities

• Coordinate end-to-end inspection and audit activities.
• Manage inspection calendars, room bookings, and site access.
• Prepare inspection logistics trackers and SME schedules.
• Assist in document compilation and verification for inspections.
• Support regulatory intelligence monitoring and remediation tracking.
• Drive continuous improvement of audit and inspection processes.
• Collaborate with cross-functional teams to implement risk-based improvements.

Skills

QA / Compliance experience

Internal auditing

CAPA management

Regulatory knowledge

Education

Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related scientific discipline

Job description

Role Purpose

To support in ensuring successful planning, coordination, and execution of client and regulatory inspections. This role is highly hands-on, with a focus on audit logistics, documentation management, and cross-functional communication to maintain site inspection readiness.

Key Responsibilities

1. Support end-to-end inspection and audit coordination activities including:
   • Logistic support:
     • Scheduling of audits and maintaining inspection calendars
     • Arranging meeting rooms, logistics, and site access for auditors/inspectors
     • Coordinating agendas and inspection plans with internal stakeholders
     • Prepare and manage inspection logistics tracker (audit rooms, SME schedules, document readiness)
   • Preinspection readiness Coordination (inspection scheduling, agenda alignment, document compilation, SME coordination, risk and hot topic identification, and rehearsal of inspection scenarios):
     • Assist in document compilation and verification (SOPs, reports, logs, validation documents, etc)
     • Coordinate with SMEs to ensure timely availability of requested documents
     • Support mock audits, rehearsals, and readiness walkthroughs
     • Track and follow up on pre-inspection action items and readiness gaps
     • Support during inspection execution in managing document request and responses, track questions, clarification and commitments.
2. Support in performing systematic trend analysis of audit, selfinspection, and regulatory observations , identifying recurring issues, compliance risks, and continuous improvement (CI) opportunities within the QMS, and provide actionable recommendations to functional owners and senior management.
3. Drive continuous improvement of audit, inspection, and selfinspection processes , including:
   • Optimization of inspection readiness and audit execution models
   • Enhancement of audit and inspection tools, templates, and tracking systems
   • Collaboration with crossfunctional teams to implement process improvements using riskbased and Lean principles
4. Monitor global and local regulatory requirements and inspection trends (e.g., FDA, EMA, HSA, ICH, PIC/S):
   • Perform regulatory intelligence monitoring and impact assessments
   • Lead sitelevel gap assessments against new or evolving regulatory expectations
   • Drive implementation and tracking of remediation and compliance actions
   • Track site level regulatory commitments and authority observations , ensuring:
     • Clear ownership and prioritization
     • Timely, effective, and compliant remediation
     • Implementation of lessons learned to sustain inspection readiness
   • Perform other compliance related duties and special assignments as directed by management.

Qualifications / Requirements

Education

• Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific discipline
• Advanced degrees are an advantage

Experience

• 2-4 years (or as appropriate for level) of experience in QA, Compliance, Quality Systems, or Regulatory Compliance.
• Experience in pharmaceutical, biotech, or CDMO environments is preferred; however, candidates from other regulated industries with relevant audit/compliance exposure are encouraged to apply
• Hands-on experience as an internal auditor / audit team member
• Hands-on experience managing CAPAs, audit responses, and regulatory commitment is an advantage

Regulatory & Quality Knowledge

• Strong working knowledge of GMP regulations and guidelines including FDA 21 CFR Parts 210/211, EU GMP, PIC/S, ICH Q7/Q9/Q10
• Solid understanding of Quality Management Systems (QMS), inspection readiness, and risk-based compliance approaches
• Experience in regulatory requirement monitoring, gap assessment, and remediation execution

Skills & Competencies

• Strong inspection hosting, communication, and stakeholder-management skills, with the ability to interact confidently with regulators and clients
• Ability to analyze inspection and audit observations, identify systemic issues, and propose practical, sustainable improvements
• Excellent technical writing skills, particularly for audit report