R&D Process Excellence Director
Location: UK – London – New Oxford Street, UK; Hertfordshire – Stevenage, USA – Pennsylvania – Upper Providence
This role is part of the R&D Written Standards and Compliance Learning Organization. It is responsible for simplifying R&D processes, collaborating with Process Owners and Subject Matter Experts (SMEs), and ensuring that procedures meet written standards and regulatory requirements. The position contributes to the quality and integrity of processes and documents, supporting successful implementation across R&D.
Responsibilities
* Create a strategy with the Process Owner to define the information package required for each process, identifying and securing the necessary SME resource to simplify and deliver it.
* Lead projects to develop the package of information for a process (or process change) that may include SOPs, templates, how‑to guides, and communication materials, ensuring timely, high‑quality delivery.
* Lead the contribution of functional area representatives, including learning developers and learning systems experts, authoring documents and leading the comments‑resolution process while ensuring consistency of writing style and documentation standards.
* Drive Process Owners and SMEs to develop and approve the package of information (including associated training) that describes the process simply and supports compliance with relevant laws and regulations.
* Challenge SMEs on the appropriate level of detail to maintain simple, clear, and effective processes and documents for users.
* Ensure integration of the information into the process landscape by identifying potential overlaps and interactions with other topics, resolving issues with relevant SMEs and Process Owners.
* Perform impact assessments and complete resulting actions to mitigate risk to impacted processes from proposed changes.
* Collaborate with other Written Standards and Compliance Learning members to facilitate delivery of a package of information and its accessibility via a one‑stop‑shop.
* Partner with Process Owners and other experts, including Quality, to govern the documentation package, maintaining its integrity and simplicity and escalating issues when higher‑level governance is required.
* Proactively seek feedback to continually improve service levels through innovation and increased efficiency in development and delivery of processes and documents.
Basic Qualifications
* Bachelor’s Degree in Life Sciences or a scientific discipline.
* Experience in the pharmaceutical industry within a Research and Development setting.
* Experience authoring procedural documents, document management, and/or medical writing.
* Working knowledge of drug development processes and regulatory requirements.
* Experience in matrix management, influencing beyond line of authority, and project leadership and management.
* Proven stakeholder management and business partnering skills and work experience.
Preferred Qualifications
* Aware of Lean Six Sigma or operational excellence principles.
* Proficient in problem solving and root‑cause analysis.
* Leadership skills.
* Knowledge of Good Laboratory Practice (GLP) or other GxPs.
* Familiarity with process design and process mapping.
* Quality mindset.
* Ability to transform complex information into simple, meaningful content.
* Ability to rapidly establish credibility and trust with experts.
* Highly developed influencing skills.
Equal Opportunity Statement
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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