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. Apply today or visit www.Julphar.net to read more about us and the journey of Julphar