R&D Process Excellence Director responsible for streamlining compliance and learning in a pharmaceutical environment. Collaborating with cross-functional teams and managing information delivery.
Responsibilities
Create a strategy with the Process Owner to define the information package required for each process
Lead projects to create the package of information for a process (or process change)
Ensure consistency of writing style, level of detail and documentation standards
Drive Process Owners and SMEs to develop and approve the package of information
Collaborate with all relevant SMEs to ensure the process and documents are fit for purpose and operationally efficient
Ensure integration of the information into the process landscape by identification of potential overlaps and interactions
Requirements
Bachelor’s Degree in Life Sciences or Scientific discipline
Experience in the pharmaceutical industry within a Research and Development setting
Experience authoring procedural documents, document management, and /or medical writing experience
Working knowledge of drug development processes and regulatory requirements
Experience in matrix management, influencing beyond your line of authority, and project leadership and management
Proven Stakeholder management and business partnering skills and work experience.
Awareness of lean sigma / operational excellence
Problem solving and root causing of issues.
Good Laboratory Practice (GLP) knowledge or other GxPs
Familiarity with process design and process mapping
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