[Hiring] Process and Quality Document Manager @ICON plc

Role Description

The Process & QD Manager performs various activities in support of process elaboration, design/mapping, documentation 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.

Key Role Responsibilities

• Process Management (BPC role):
  • Supports/guides BPOs in the process to develop or update process design.
  • Ensures adherence to R&D documentation standards, process orientation, simplification, visualization, regulatory compliance, and harmonization of processes and QDs within GDO.
  • Develops/revises process flow diagrams using the designated system and notation standards.
• Controlled Document & Managed Information Document Management:
  • Responsible for the development, review/revision, maintenance, and continuous improvement of Quality Documents for GDO.
  • Ensures timely review/revision of existing processes & QDs within GDO.
  • Owns GDO Managed Information Document ManGo Cabinet.
  • Coordinates review and revision of documents with all appropriate stakeholders.
  • Ensures compliance with document content and formatting standards.
  • Represents GDO in Merck Healthcare R&D Development Excellence Council (DEC).
  • 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.

Qualifications

• 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).

Requirements

• 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:
  • Excellent organizational and communication skills, change agility, and quality-driven mindset.
  • Pronounced active listening skills and ability to articulate and formulate decisions and actions in a clear business language.
• Strategic planning:
  • Excellent understanding of the requirements of the pharmaceutical industry and in particular drug development/Good Clinical Practice.
  • Ability to identify opportunities to increase efficiencies in processes, including through use of automation.
  • Ability to prioritize and work in rapidly changing environment.
• Stakeholder management:
  • Ability to interface with various external and internal stakeholders and engage in a constructive solution-oriented manner.
  • Ability to work both independently and collaboratively.
  • Consistently demonstrates a global thinking/mindset with balanced cultural awareness.
  • Fluent in verbal and written English.
  • Persuasive communication skills.
• Leadership:
  • Strong mature leadership and influencing skills.
  • Fosters an environment that nurtures open dialogue and encourages people to raise and discuss critical issues.
• Analytical Thinking:
  • Technical analytical skills with ability to analyze and interpret outcomes.
  • Mindset to develop effective business strategies and operational plans to deal with current and future industry trends.

Benefits

• 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, offering 24-hour access to a global network of over 80,000 independent specialised professionals.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.