Sr Manager - Audit Management And Inspection Readiness

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Detailed Job Description

The Audit Program Manager is responsible for developing, executing, and continuously improving a robust internal and external audit program. This role ensures that auditing activities are aligned with GMP regulations, company policies, and international standards while fostering a culture of quality, compliance, and ethical conduct.

Key Responsibilities

• 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.
  

• Education: Bachelor’s or Master’s degree in Pharmacy (or related scientific discipline).
• Experience: Minimum 10 years in the pharmaceutical industry with a strong background in Quality Management Systems and audit leadership.
• Regulatory Knowledge: Extensive knowledge of cGMP and international regulatory guidelines.
• Technical Skills: Proficient in Microsoft Office (Word, Excel, PowerPoint); familiarity with EQMS platforms (e.g., AmpelLogic) preferred.