Sr. Manager - Audit Management & Inspection Readiness

Audit Program Governance

• Establish a structured and impartial audit program that ensures objectivity and transparency in all auditing activities.

• Define controls such as procedures, audit criteria, plans, and objectives to maintain an effective and efficient audit framework.

• Identify internal/external issues, risks, and opportunities affecting the audit program, and integrate appropriate actions into all relevant audit processes.

Audit Planning & Execution

• Develop and manage audit schedules (internal and external) in alignment with management priorities and business needs.

• Define audit objectives, scopes, criteria, and methodologies. Assign qualified auditors and ensure proper audit team composition based on scope and complexity.

• Monitor and evaluate auditor performance to ensure competence, objectivity, and professionalism.

Audit Team Management

• Qualify, train, and coach auditors to maintain a high standard of auditing expertise and ethical behavior.

• Ensure clear assignment of roles, responsibilities, and authorities within the audit team.

• Foster leadership and team collaboration throughout the auditing process.

Audit Operations & Follow-up

• Ensure timely execution of audits, adherence to timelines, and follow-up on audit findings and CAPA responses.

• Coordinate the review and approval of audit plans, verify the adequacy of audit bases, and validate the experience of Lead Auditors against audit scopes.

• Maintain effective internal and external communication throughout the audit lifecycle, including resolution of disputes and complaints.

Documentation & Reporting

• Maintain complete and accurate records of audit programs, plans, reports, CAPA responses, and approvals in the EQMS system (e.g., AmpelLogic).

• Ensure timely distribution of audit reports to vendors and track CAPA responses for closure with supporting evidence.

• Report audit program performance to management, including KPIs, closure status, and pending actions for Quality Council reviews.

Quality & Compliance Support

• Support inspection readiness and regulatory audits as needed.

• Contribute to Quality Management System (QMS) improvements using structured quality tools and methodologies.

• Perform an annual review of the audit system and audit plan to ensure alignment with strategic and compliance requirements.

• Ensure confidentiality of audit program data and protect sensitive third-party information.

• Promote a strong ethical culture within audit teams and throughout the audit program.

Strategic Contribution

• Align audit program objectives with business goals and support broader company initiatives and development strategies.

• Uphold a risk-based, process-oriented approach to continuous improvement and compliance excellence.

Expertise in Quality & Auditing

• Deep knowledge of QMS, cGMP, regulatory standards (e.g., FDA, EMA, WHO), and auditing principles.

Leadership & Ethics

• Completed formal Auditor Qualification Program; demonstrates ethical integrity and adherence to organizational codes of conduct.

Risk & Process Management

• Applies risk-based thinking, process optimization, and quality improvement tools to drive audit efficiency and effectiveness.

Communication & Collaboration

• Strong communication, presentation, and stakeholder engagement skills with the ability to manage cross-functional teams.

Business Acumen & Results Focus

• High ownership, accountability, adaptability, and cost-conscious decision-making aligned with business objectives.