Process and Quality Document Manager
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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
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
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
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
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
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Competitive base salary and performance related incentives
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Health and wellbeing programmes including medical, dental, and vision coverage where applicable
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Retirement and pension plans
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Life assurance and disability coverage
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Employee assistance programmes and wellbeing resources
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Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
