全职 Quality Compliance Lead 工作, 薪水, WuXi XDC 公司招聘中 - Ricebowl

Overview:

The Compliance Lead is responsible for leading the site Quality Compliance function and ensuring a sustainable state of GMP inspection readiness across all quality systems and GMP operations. The role serves as the primary site authority for compliance oversight, regulatory intelligence, inspection management, self-inspection programs, and compliance risk management.

The Compliance Lead drives a proactive quality and compliance culture through effective governance, trend analysis, continuous improvement initiatives, and cross-functional partnership to ensure compliance with applicable regulatory requirements and company standards.

As part of this role, successful candidate will complete a 6-month assignment at Wuxi China site, gaining valuable experience prior to returning to Singapore to support XDC Singapore operations.

Key Responsibilities

Lead and manage the full lifecycle of client and regulatory inspections/audits

• Pre‑inspection readiness planning (inspection scheduling, agenda alignment, document compilation, SME coordination, risk and hot‑topic identification, and rehearsal of inspection scenarios)
• On‑site inspection hosting and coordination, including direct engagement with inspectors/auditors and facilitation of cross‑functional responses
• Post‑inspection activities including observation triage, CAPA strategy development, formal response drafting, submission, and closure tracking

Act as the primary site focal point for client and regulatory inspections

• Ensuring consistent, compliant, and confident representation of the site Quality System and operations.

Own and lead the 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

Perform 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

Lead and 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

Provide compliance guidance and advisory support to site leadership and cross‑functional teams:

• Support for audit readiness, self‑inspection findings, regulatory risks, and Quality System enhancements.

Perform other compliance‑related duties and special assignments as directed by management.

Qualifications / Requirements

• Bachelor’s degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific discipline
• 10-15 years (or as appropriate for level) of experience in QA Compliance, Quality Systems, or Regulatory Compliance within pharmaceutical, biotech, or CRDMO environments.
• Proven experience hosting and managing regulatory inspections (e.g. FDA, EMA, HSA, PIC/S) and client audits.
• Demonstrated experience as owner or lead of site self‑inspection programs
• Hands‑on experience managing CAPAs, audit responses, and regulatory commitments.
• 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)