Deputy Manager - QA

Experience & Technical Competencies

• 12-15 years of relevant experience in Quality Assurance, Quality Systems, and Regulatory Compliance within the pharmaceutical, biotechnology, or life sciences industry.
• Proven experience in handling regulatory inspections, customer audits, internal audits, and vendor audits.
• Strong expertise in QMS processes, including Change Control, Deviations, OOS/OOT, CAPA, Complaints, and Recalls.
• Hands-on experience in qualification, validation, and quality risk assessments.
• Working knowledge of computerized system validation and GxP applications.
• Strong understanding of data integrity requirements, ALCOA+ principles, and audit trail reviews.
• Experience in cGxP gap assessments, remediation planning, and compliance monitoring.
• Knowledge of applicable regulatory guidelines, including WHO GMP, US FDA requirements, EU GMP, ICH guidelines, and relevant electronic records regulations, as applicable to the site.

Key Responsibilities

1. Audits, Inspections & Compliance

• Plan, coordinate, and manage internal and external audits, including customer, regulatory authority, and vendor audits.
• Lead site readiness activities for regulatory inspections and customer audits.
• Coordinate audit responses, observations, commitments, and corrective and preventive action (CAPA) implementation.
• Review audit findings, perform root cause analysis, and ensure timely and effective closure of CAPAs.
• Monitor the effectiveness of corrective actions and drive continuous compliance improvement.
• Conduct periodic vendor audits and supplier quality assessments in accordance with approved procedures and regulatory requirements.

2. Quality Management System (QMS) Operations

• Manage and oversee end-to-end QMS processes, including:
• Change Control Management
• Deviation and Incident Management
• Out-of-Specification (OOS) and Out-of-Trend (OOT) Investigations
• CAPA Management
• Product Quality Complaints
• Product Recall Management.

3. Qualification & Validation

• Review and oversee qualification activities for equipment, instruments, utilities, and facilities.
• Review and approve validation protocols, reports, and related documentation, as applicable.
• Oversee process validation, cleaning validation, and other relevant validation activities.
• Ensure compliance with applicable regulatory requirements and established validation lifecycle procedures.
• Review quality risk assessments and ensure appropriate risk mitigation measures are implemented.
• Ensure periodic review and continued validated state of equipment, facilities, processes, and systems.

4. Computerized System Validation (CSV) & GxP Compliance

• Oversee computerized system validation and lifecycle management of GxP-regulated applications.
• Review and assess validation documentation, including validation plans, risk assessments, requirements specifications, testing protocols, traceability matrices, and summary reports.
• Ensure appropriate controls for system access, user roles, audit trails, electronic records, and electronic signatures.
• Verify compliance with applicable regulatory requirements, including 21 CFR Part 11 and EU GMP Annex 11, where applicable.
• Support periodic reviews of computerized systems and ensure appropriate control of system changes, incidents, and deviations.

5. cGxP Gap Assessment & Remediation

• Conduct site-wide cGxP compliance gap assessments against applicable regulatory requirements and industry standards.
• Identify compliance gaps, assess associated risks, and develop remediation plans.
• Coordinate with cross-functional teams to implement corrective actions within agreed timelines.
• Track remediation progress, assess effectiveness, and provide periodic compliance status reports to site management.
• Ensure sustained compliance through periodic reviews, internal assessments, and continuous improvement initiatives.

6. Data Integrity & Governance

• Conduct data integrity assessments across functions, including Quality Assurance, Quality Control, Manufacturing, Engineering, and other relevant departments.
• Assess compliance with ALCOA+ principles and applicable data integrity requirements.
• Evaluate controls for electronic and paper-based records, audit trails, access management, data review, backup, and retention.
• Identify data integrity risks and implement appropriate mitigation measures.
• Review audit trail controls and ensure appropriate review practices for critical GxP systems.
• Provide guidance and training to functional teams on data integrity requirements and best practices.

7. Cross-Functional Coordination & Continuous Improvement

• Collaborate with QA, QC, Manufacturing, Engineering, IT, Validation, Regulatory Affairs, and other stakeholders to ensure effective quality system implementation.
• Provide technical guidance on quality and compliance matters.
• Develop and monitor quality KPIs, compliance dashboards, and periodic management reports.
• Support quality risk management, inspection readiness, and continuous improvement initiatives.
• Mentor team members and promote accountability, compliance awareness, and a culture of quality.