Quality Compliance Specialist

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:

o Scheduling of audits and maintaining inspection calendars

o Arranging meeting rooms, logistics, and site access for auditors/inspectors

o Coordinating agendas and inspection plans with internal stakeholders

o 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):

o Assist in document compilation and verification (SOPs, reports, logs, validation documents, etc)

o Coordinate with SMEs to ensure timely availability of requested documents

o Support mock audits, rehearsals, and readiness walkthroughs

o Track and follow up on pre-inspection action items and readiness gaps

o Support during inspection execution in managing document request and responses, track questions, clarification and commitments.

Post inspection activities (observation triage, CAPA strategy development, formal response drafting, submission, and closure tracking):

o Support in preparing and consolidating audit response packages and documentation, maintaining trackers for CAPAs response and timeline.

o Follow up with stakeholders to ensure on-time deliverables.

2. Support site Self Inspection Program, including:

o Establishing and maintaining a compliant, risk based self inspection strategy aligned with regulatory expectations

o Developing annual self inspection plans, scopes, and schedules

o Leading and/or coordinating cross functional self inspection activities

o Ensuring timely issuance of self inspection reports and effective follow up, tracking, and closure of CAPAs

o Trending self inspection findings to identify systemic issues and inspection readiness gaps

3. 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.

4. Drive continuous improvement of audit, inspection, and self inspection processes, including:

o Optimization of inspection readiness and audit execution models

o Enhancement of audit and inspection tools, templates, and tracking systems

o Collaboration with cross functional teams to implement process improvements using risk based and Lean principles

5. Monitor global and local regulatory requirements and inspection trends (e.g., FDA, EMA, HSA, ICH, PIC/S):

o Perform regulatory intelligence monitoring and impact assessments

o Lead site level gap assessments against new or evolving regulatory expectations

o Drive implementation and tracking of remediation and compliance actions

6. Track site level regulatory commitments and authority observations, ensuring:

o Clear ownership and prioritization

o Timely, effective, and compliant remediation

o Implementation of lessons learned to sustain inspection readiness

7. 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 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)