Research Development Quality and Risk Management Inspection

Coordinates the preparation, execution and close out all GCP/GLP/GVP Health Authority Inspections of Healthcare R&D (hereafter referred to as Healthcare R&D) projects or facilities. Leads/coordinates pre-inspection setup activities in collaboration with Healthcare R&D stakeholders and external business partners.

Prepares and educates internal and external business partners on inspection management.Coordinates setup activities with inspectors by ensuring:Communication line with the inspectors is established.Required information is collected.Clarification on the inspection agenda (if required).Hosts inspections and/or participates in inspections by providing full operational support to the respective inspection leads (Front Room, Back Room, etc.) .

Coordinates response to pre-inspection requests.Coordinates creation and distributes inspection daily summaries.Coordinates the creation of the inspection responses by ensuring Assignment of Subject Matter Experts.Lead response team meetings.Consolidation of responses.Coordination of review as per inspection management process.Ensuring delivery of response to inspectors.Records inspection data/information in the respective electronic system in a timely manner as per established processes for Inspection Management.

Collaborate with respective RDQ group to ensure corrections, corrective action and preventive actions for inspectional observations are tracked through to closure.Develops and oversees implementation and maintenance of proactive Inspection Readiness Strategies. This includes Oversight on tools used for inspection readiness.Oversight on the inspection readiness state of project, studies and country offices.Oversight on training approach in relation to inspection readiness process and tools.

Maintains an effective and controlled inspection process within Healthcare R&D worldwide (e.g. global inspection standard etc.).Establishes of an effective and controlled inspection communication process within the Merck Group, especially within Healthcare R&D worldwide (e.g. inspection alert channel, mayday distribution list, inspection action team, etc.).Drive active and regular knowledge sharing and lessons learned from previous inspections.Provides regular and timely reports on overall inspection status, global response status and associated CAPA completion/close out, allowing for and contributing to state-of-the-art Quality Reporting.

Enforces the continuous evaluation of publicly available inspection reports/ information from various sources (e.g. regulatory agencies, internet platforms, other Merck quality groups, intercompany working groups and Pharmaceutical Associations) to proactively develop and maintain an up-to-date Inspection Intelligence, identifying potential new or upcoming issues of significance and to foresee/ confirm new inspection trends or expectations.Develops and maintains standardized and harmonized tools for the preparation, conduct, reporting and follow-up of inspections.

Assists in developing the global quality strategy and implementing/ maintaining the associated Quality Management System.Participates in special assignments on various project teams and work streams as determined by RDQ Management.Maintains high level of awareness, expertise on international applicable regulations and provides input to the development of internal R&D procedures as assigned by RDQ Management.Ensures rapid communication of QA issues, including potential misconduct or issues of significant deviations with projects/product, to appropriate leaders and colleagues.Defines the joint processes for collaboration on inspection preparation, notification, conduct, response with external providers.Coordinates mock inspections in line with established processes for inspection management process. Required professional experience and necessary training University degree in Mininum Bachelor degree, University degree preferred in scientific or quality-related subjectsAdvanced degree in relevant subjects preferredNecessary professional experience

Minimum 8 years QA experience or relevant experience in international pharmaceutical and/or biotech industry, in particular clinical quality management, clinical development, or regular compliance with a minimum of 5 years in Clinical QA.Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance - including those related to Risk Based Quality Assurance and Quality by Design.Sound experience with Regulatory Authorities inspections (sponsor, site, vendor) by major authorities such as MHRA, FDA, EMA, PMDA.In depth knowledge of drug development processes and respective international regulations and guidelines. Including specific areas of interest for Healthcare R&D e.g. oncology, biotherapeutics, biosimilars and emerging markets.Medical expertise preferred to identify potential consequences of detected issues and to assess proposed measures.

Broad working knowledge of relevant GxP areas (e.g. GCP, GLP, GVP)Basic knowledge of other GxP areas (e.g. GMP, GDP).Specifies personal skills and competencies requiredDemonstrated good interpersonal, communication, organizational, presentation skills, influencing, and problem- solving capabilities.Demonstrated ability to work independently and manage time efficiently and effective.Demonstrate awareness of cultural differences and impact of team/personal behaviorStrong negotiation skills and strategic thinking under critical inspection conditions.

Demonstrated ability to provide informal leadership to international/interdisciplinary inspection teams.Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.Understands and appreciates the impact of integrity, gaining and keeping trust and working effectively in a changing environment.Ability to adapt to changing direction and the needs of the business Stress resilience and flexibility.Fluency in written and spoken English.