Sr. Manager - Audit Management & 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.
  

Core Competencies

• 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.
  

Qualifications & Experience

• 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.
  
  

We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar