Project Manager: Audit Readiness

Terumo Europe NV; Leverkusen; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Bonus

Company Car

Professional development

Job summary

Terumo Europe NV in Leverkusen seeks an Audit Readiness Scrum Master / Project Manager to lead the site-wide Audit Readiness Programme, coordinating across Quality, Operations and supporting functions. You will combine regulatory, FDA and GMP expertise with Scrum and project management to deliver a clear roadmap and drive readiness.

You will embed Constant Inspection Readiness, manage risks with the Site Risk Register, and oversee mock inspections and regulatory inspections while reporting to

Qualifications

• Certified Scrum Master training or certification.
• Hands-on project management of complex, cross-functional programs.
• Experience coordinating with Quality, Operations and regulatory functions.
• Familiarity with FDA inspections and GMP requirements.
• Strong analytical, communication and stakeholder-management skills.

Responsibilities

• Lead the Audit Readiness Program as Scrum Master and Project Manager.
• Establish roadmap, governance, milestones and priorities across workstreams.
• Coordinate subject-matter experts, deliverables and stakeholders; ensure momentum.
• Identify, assess and close audit/readiness gaps; maintain Site Risk Register.
• Coordinate mock inspections and regulatory inspections; report progress to leadership.

Skills

Scrum Master

Project Management

FDA inspections

GMP knowledge

Regulatory understanding

Stakeholder management

Tools

Site Risk Register

QA Boards

KPI dashboards

Job description

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for.

Department Info

Terumo Pharmaceutical Services GmbH in Leverkusen is part of Terumo Pharmaceutical Solutions and operates within our CDMO business, supporting pharmaceutical customers in the manufacturing environment for their products.

Within this setting, Quality Operations plays an important role in ensuring that our activities meet the required quality and regulatory standards. The Leverkusen organisation brings together Quality, Operations and supporting functions in a highly regulated pharmaceutical manufacturing environment.

Job Summary

As Audit Readiness Scrum Master / Project Manager, you lead the site-wide Audit Readiness Programme in close cooperation with the Programme Owner.

Audit and inspection readiness requires strong coordination across Quality, Operations and supporting functions. Combining your regulatory, FDA and GMP expertise with Scrum and project management, you bring structure to the different workstreams and drive the identification and closure of readiness gaps.

Your ultimate objective is to help move the site beyond preparation for individual audits or inspections towards Constant Inspection Readiness, embedding sustainable processes and ways of working across the organisation

Job Responsibilities

Lead the Audit Readiness Program

• You lead the cross-functional Audit Readiness Programme as Scrum Master and Project Manager, working closely with the Programme Owner.
• By establishing a clear roadmap, governance, milestones and priorities, you create direction across the different workstreams.
• Coordinating subject-matter experts, stakeholders and deliverables, you maintain momentum and drive accountability.
• Potential barriers are addressed proactively to keep critical actions and programme objectives on track.

Drive risk identification and gap closure

• You coordinate the identification, assessment and timely closure of audit and inspection readiness gaps.
• Establishing and maintaining the Site Risk Register provides clear visibility on risks, priorities, ownership and progress.
• With an analytical and structured approach, you help stakeholders translate regulatory and quality requirements into concrete actions.
• Constructively challenging teams and action owners allows you to drive decisions and results.

Coordinate audit and inspection readiness

• You coordinate preparation activities, including mock inspections and support during regulatory inspections.
• Close collaboration with Quality, Operations and supporting functions ensures strong cross-functional ownership.
• KPIs, QA Boards, management reporting and appropriate governance provide transparency on progress and key risks.
• Through effective facilitation, you bring stakeholders together and maintain focus in a demanding regulatory environment.

Build sustainable readiness capabilities

• You help embed Constant Inspection Readiness as an ongoing way of working across the site.
• Critical regulatory and GMP knowledge, lessons learned and best practices are systematically captured and retained within the organisation.
• Effective tools and approaches are transferred into day-to-day operations, strengthening the site's long-term readiness capability

You are an experienced Project Manager and Scrum Master who combines strong programme execution with regulatory, FDA, and quality expertise.

You bring:

• Several years of hands-on project management experience, ideally managing complex, cross-functional programmes and multiple workstreams.
• Certified Scrum Master training or certification.
• Practical experience as an FDA Project Manager during at least four FDA inspections.
• Proven experience leading an FDA inspection within a sterile manufacturing environment.
• Broad practical knowledge of GMP, Quality Management Systems, and regulatory inspection readiness.
• A strong understanding of sterile manufacturing, aseptic processing, and relevant GMP requirements.
• Experience establishing and managing a Site Risk Register.

Strong organisational and execution skills, enabling the creation of structure, maintenance of momentum, and driving of accountability.

Excellent communication, facilitation, and stakeholder-management capabilities, allowing influence across functions and organisational levels.

A structured, analytical, and solution-oriented mindset, combined with the assertiveness and resilience to perform effectively in a demanding environment.

Experience with EU GMP Annex 1, Contamination Control Strategy, sterile or fill-finish operations, IWS, Tier Meetings, Daily Direction Setting, KPI or QA Boards, and visual management systems is an advantage.

Experience within a multinational pharmaceutical organisation is equally valuable.

Above all, the ability to bring structure to complexity and turn plans into execution. Leading through influence, constructively challenging stakeholders, and keeping multidisciplinary teams aligned around priorities, actions, and results.

At Terumo, you join an international healthcare organisation where your work directly contributes to maintaining high quality and regulatory standards.

We offer:

• A permanent, full-time position with the opportunity to establish and shape a site-wide Audit Readiness Programme.
• A highly visible project management role with impact across Quality, Operations and supporting functions.
• The opportunity to help build sustainable audit and inspection readiness capabilities across the site.
• An international pharmaceutical environment with exposure to senior stakeholders and cross-functional teams.
• Continuous learning and professional development in regulatory readiness, quality systems and programme leadership.
• A competitive compensation package, including a bonus, company car option and other benefits.
• A people-focused culture where collaboration, wellbeing and professional growth are valued.

Most importantly, you become part of a company where Advancing Healthcare with Heart reflects our ambition to combine innovation in healthcare with a genuine commitment to people.