QA Specialist, Compliance

WuXi XDC; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

WuXi XDC is seeking a QA/Regulatory Compliance professional to support end-to-end inspection coordination, self-inspection programs, and trend analyses across regulatory bodies. The role emphasizes cross‑functional collaboration, CAPA management, and alignment with GMP guidelines to maintain inspection readiness.

You will lead or coordinate multi‑disciplinary teams, ensure timely documentation and responses to regulator inquiries, and drive continuous improvement in audit and inspection

Qualifications

• Bachelor’s degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific discipline
• 2–4 years of experience in QA, Compliance, Quality Systems, or Regulatory Compliance
• Experience in pharmaceutical, biotech, or CDMO environments preferred; other regulated industries with audit exposure welcome
• Hands‑on experience as an internal auditor / audit team member
• Hands‑on experience managing CAPAs, audit responses, and regulatory commitments is advantageous
• 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 QMS, inspection readiness, and risk‑based compliance approaches
• Experience in regulatory requirement monitoring, gap assessment, and remediation execution
• Strong inspection hosting, communication, and stakeholder‑management skills

Responsibilities

• Support end‑to‑end inspection and audit coordination activities including logistic support, pre‑inspection readiness, and post‑inspection activities
• Support site Self‑Inspection Program with risk‑based strategies, annual plans, cross‑functional coordination, and CAPA follow‑ups
• Perform systematic trend analysis of audit, self‑inspection, and regulatory observations to identify systemic issues
• Drive continuous improvement of audit, inspection, and self‑inspection processes using Lean principles
• Monitor regulatory requirements and inspection trends (FDA, EMA, HSA, ICH, PIC/S) and lead gap assessments
• Track site level regulatory commitments and authority observations with clear ownership and remediation

Skills

Internal auditing

Audit coordination

CAPA management

Regulatory compliance

GMP knowledge

Quality Systems

Documentation writing

Stakeholder management

Lean principles

Education

Bachelor's degree in a scientific discipline

Job description

• 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:

Support end-to-end inspection and audit coordination activities including

• Logistic support
• Pre‑inspection readiness Coordination
• Post‑inspection activities

Support site Self‑Inspection Program

• Establishing and maintaining a compliant, risk‑based self‑inspection strategy aligned with regulatory expectations
• Developing annual self‑inspection plans, scopes, and schedules
• Leading and/or coordinating cross‑functional self‑inspection activities
• Ensuring timely issuance of self‑inspection reports and effective follow‑up, tracking, and closure of CAPAs
• Trending self‑inspection findings to identify systemic issues and inspection readiness gaps

Support in performing systematic trend analysis of audit, self‑inspection, 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.

Drive continuous improvement of audit, inspection, and self‑inspection processes

• Optimization of inspection readiness and audit execution models
• Enhancement of audit and inspection tools, templates, and tracking systems
• Collaboration with cross‑functional teams to implement process improvements using risk‑based and Lean principles

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 site‑level 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

• Clear ownership and prioritization
• Timely, effective, and compliant remediation
• Implementation of lessons learned to sustain inspection readiness

Requirements:

• Bachelor’s degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific discipline
• Min 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
• 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
• 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 reports, inspection responses, and CAPA documentation
• Strong leadership skills with the ability to influence cross‑functional teams and drive compliance culture
• Experience applying risk‑based thinking and continuous improvement (CI) principles (Lean knowledge is an advantage)