Process and Quality Document Manager
Location
Germany
Posted
90 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Process and Quality Document Manager
ICON plc
Process and Quality Document Manager ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Process & QD Manager performs various activities in support of process elaboration, design/mapping, documentation (controlled documents and managed information documents) development, review, formatting, and revision for Global Development Operations (GDO). Support focuses on ensuring that good process design principles and appropriate documentation standards are consistently applied, that activities are consistently and efficiently coordinated and that deliverables are completed in a high quality and timely manner. Support may also be provided to coordinate audits and audit response processes and to ensure compliance with agreed CAPA due dates, as needed. In addition, the Process & QD Manager is in charge of coordinating GDO training assignments, Managed Information and cross-functional QD reviews (incl.representation of GDO in Development Excellence Council). Key Role Responsibilities Process Management (BPC role): • Supports/guides BPOs in the process to develop or update process design (end-to-end Process design including set-up expectations, perform Elaboration Workshop and coordinate Cross-functional Alignments, Document Authoring responsibilities) • Ensures adherence to R&D documentation standards, process orientation, simplification, visualization, harmonized core language, regulatory compliance and harmonization of processes and QDs within GDO • Develops/revises process flow diagrams using the designated system and notation standards and supports the GDO organization as an expert for efficient process design and illustration Controlled Document & Managed Information Document Management: • Responsible for the development, review/revision, maintenance and continuous improvement of Quality Documents (incl. CDs and MIs) for GDO • Ensures timely review/revision of existing processes & QDs within GDO, maintaining compliance with review/renewal timelines • Owns GDO Managed Information Document ManGo Cabinet • Coordinates review and revision of documents with all appropriate stakeholders in cooperation with the process/document owner • Ensures compliance with document content and formatting standards • Represents GDO in Merck Healthcare R&D Development Excellence Council (DEC) and manages related activities • Ensures timely and adequate communication on behalf of the DEC to the GDO organization Training Management and Oversight: • Maintains training matrix, coordinates training roles, and works with Training Representatives to optimize assignments in GDO Audits and Inspections: • Supports the preparation, coordination, and response for audits and inspections, as appropriate to area of responsibility Requirements • Experience in clinical research in a CRO, pharma or biotech company • Knowledge of ICH Good Clinical Practice (GCP) guidelines • Knowledge of Good Documentation Practices • Solid organizational skills, including multitasking and time-management • Good interpersonal skills • Demonstrated good written and verbal communication skills • Fluency in English (oral and written) • Experienced user of MS Office 365 toolset (Word, Excel, SharePoint, PowerPoint etc) Preferred • Document management experience • iGrafx/process design experience • GCP audit/inspection support experience Education • Advanced degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) or equivalent Experience • Minimum 12 years of experience in clinical development in pharmaceutical industry or CRO or equivalent including at least 5 years direct involvement in sponsor – CRO interaction for global trials • Experience in different functions in the clinical development area • Experience as line manager and/or as leader of cross-functional virtual international teams Job Specific Competencies and Skills • Communication o Excellent organizational and communication skills, change agility, and quality-driven mindset o Pronounced active listening skills and ability to articulate and formulate decisions and actions in a clear business language • Strategic planning o Excellent understanding of the requirements of the pharmaceutical industry and in particular drug development/Good Clinical Practice with good knowledge of Quality Management Systems and Good Documentation Practices o Ability to identify opportunities to increase efficiencies in processes, including through use of automation o Ability to prioritize and work in rapidly changing environment • Stakeholder management o Ability to interface with various external and internal stakeholders (different functional background, different levels) and engage in a constructive solution-oriented manner o Ability to work both independently and collaboratively. o Consistently demonstrates a global thinking/mindset with balanced cultural awareness, sensitivity and accommodating behaviors o Fluent in verbal and written English o Persuasive communication skills • Leadership o Strong mature leadership and influencing skills o Fosters an environment that nurtures open dialogue and encourages people to raise and discuss critical issues and recognizes the needs and opportunities for these discussions • Analytical Thinking o Technical analytical skills with ability to analyze and interpret outcomes o Mindset to develop effective business strategies and operational plans to deal with current and future industry trends What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
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