Quality Compliance Specialist

Summary:

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