Quality Compliance Specialist

About the role

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.

Responsibilities

• 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
• Pre inspection readiness Coordination (inspection scheduling, agenda alignment, document compilation, SME coordination, risk and hot topic identification, and rehearsal of inspection scenarios):
• Support in preparing and consolidating audit response packages and documentation, maintaining trackers for CAPAs response and timeline.
• Follow up with stakeholders to ensure on-time deliverables.
• Support site Self Inspection Program, including:
• 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, including:
• 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, 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.
• About You:
• Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific discipline
• 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)
• Duration: 12 months

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