Audit Manager

ASE-S1-05
Rx Central Quality Auditor (Process Owner)

Location: Remote
Department: Global Quality (Rx)
Reports to: Director, Global Quality Systems

Job Purpose

Develop and lead the Rx Central Quality Auditor community for the scheduling and execution of GMDP audits of CMOs and other third parties that are centrally managed, as well as internal manufacturing and supply chain organizations. Act as the Rx audit process owner—establishing and maintaining systems, standards, and metrics that enable effective, risk-based management of auditing activities across Mundipharma in accordance with current legislation, relevant standards and guidelines. Provide expert advice to internal and external customers, collaborate across auditing groups to define global standards and ways of working, and drive the sharing of best practices.

Key Responsibilities

Personnel

• Build and lead the auditor community for Rx, ensuring effective scheduling and execution of GMDP audits of CMOs, third parties, and internal manufacturing/supply chain organizations; support cross-functional audits (e.g., Cx, R&DQA, SOG).
• Talent identification & development: Liaise with Product Supply, Network, and Quality Systems teams to identify and develop individuals capable of undertaking different Rx audit types.
• Cross-GxP collaboration: Coordinate with audit leads across other GxPs/product types to enable cross-functional auditing where required.
• Competency management: Own the training matrix, ensuring auditors meet current and future organizational needs; collaborate with auditors’ line managers to create and track development/training plans.
• Community of practice: Motivate, coach, and support the auditor community; foster global sharing of best practices and standard ways of working.

Performance

• Audit systems ownership: Establish and maintain effective processes and procedures aligned to the Mundipharma Quality Framework, policies, GxP, and local regulatory requirements.
• Risk-based audit schedule: Build and manage the Rx global audit schedule for CMOs, third parties, and internal sites; ensure audits are performed to plan, to applicable standards, and per Mundipharma procedures.
• Resourcing: Ensure appropriate resources (internal or outsourced) with the right training and experience are available to execute the plan.
• Metrics & reporting: Define, monitor, and communicate metrics to proactively identify improvement opportunities and drive action within audit operations; escalate potential compliance risks related to audited entities.
• Quality Agreements & CAPA: Assess compliance to established Quality Agreements; ensure findings are resolved through effective CAPA, monitored to closure.
• Issue management: Ensure effective communication, timely escalation, and follow-up on issues impacting product quality, safety, and efficacy.
• Continuous improvement: Identify and implement opportunities that enhance compliance posture and audit operational efficiency and effectiveness.

Good Manufacturing Practice (GMP)

• GMDP/GxP compliance: Ensure audit activities uphold GMDP/GxP, pharmacopoeia requirements, and local regulations; maintain robust, compliant audit SOPs/work instructions and data integrity practices.
• Quality Risk Management (QRM): Demonstrate strong QRM application to define audit frequency and scope; collaborate with functions (e.g., MITO SCA, Bard QA) to ensure risk processes are used to drive risk-based auditing.
• Inspection readiness: Support internal audits and the hosting of external inspections as an auditing SME; maintain audit records and systems to inspection-ready standards.
• CPD & horizon scanning: Keep up to date with changes in legislation, guidelines, and pharmacopoeias, and with technology advancements through a structured CPD program.
• Security & stewardship: Ensure secure handling and maintenance of audit documentation and third-party data; maintain auditor independence and ethical standards.

Other

• Expert advisory: Provide authoritative guidance to internal and external stakeholders on auditing standards, approaches, and interpretation of regulations.
• Global alignment: Collaborate with other auditing groups across Mundipharma to define global minimum standards and harmonized ways of working for good auditing practices.
• Third-party engagement: Liaise with suppliers/CMOs/3rd parties during audits and follow-up, ensuring clarity of expectations and timely remediation.
• Additional duties: Perform any other reasonable tasks that support business objectives, compliance, and continuous improvement in audit operations.

Skills & Qualifications

• Education: Scientific degree in Pharmacy, Chemistry, Biology, or similar; or equivalent aligned working experience.
• Certification: Lead Auditor certification (or similar).

Why Join Mundipharma?

• Opportunity to contribute to life‑changing medicines
• Strong focus on safety, training, and career development
• Inclusive and collaborative working culture
• Competitive salary

Equal Opportunity Employer

Mundipharma is an equal opportunity employer. We welcome applicants from all backgrounds and are committed to fostering an inclusive workplace where everyone feels valued and supported.