R&D Process Excellence Director

GSK•Upper Providence, PA

About The Position

R&D Process Excellence Director The role is part of the R&D Written Standards and Compliance Learning Organization responsible for simplifying R&D processes and collaborating with Process Owners and Subject Matter Experts (SMEs) to streamline and optimize the R&D operating environment. Processes are to be executed in compliance with our written standards, specifying regulatory and business critical requirements. This role will contribute to the quality and integrity of processes and documents to support successful implementation across R&D. This role will partner with Process Owners and Subject Matter experts (SME) across R&D to develop simple and clear procedural documents, and where possible, align them to end-to-end processes.

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.

Nice To Haves

Awareness of lean sigma / operational excellence.
Problem solving and root causing of issues.
Leadership skills.
Good Laboratory Practice (GLP) knowledge or other GxPs
Familiarity with process design and process mapping
Quality mindset
Ability to transform the complex into the simple with no loss of meaning or relevance
Ability to rapidly establish credibility and trust with experts
Highly developed influencing skill.

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 create the package of information for a process (or process change) which could include development (or revision) of Standard Operating Procedures (SOPs), templates, How-to guides, communication materials. The information will be delivered on time and to high quality standards.
Lead the contribution of functional area representatives including learning developers and learning systems experts.
When appropriate, author documents and lead the comments resolution process and evaluation meetings efficiently and effectively.
Ensure consistency of writing style, level of detail and documentation standards.
Drive Process Owners and SMEs to develop and approve the package of information (including associated training) that describes the process and its operation simply to users while supporting compliance with relevant laws and regulations.
Collaborate with all relevant SMEs to ensure the process and documents are fit for purpose and operationally efficient, ensuring business benefit from package delivery.
Challenge SMEs on the appropriate level of detail required to ensure processes and documents are simple, clear, and effective for users.
Ensure integration of the information into the process landscape by identification of potential overlaps and interactions with other topic areas/processes for resolution by the relevant SMEs and Process Owners.
Ensure an impact assessment is performed and any resulting actions completed to mitigate the risk to impacted processes from implementing the proposed changes.
Collaborate with other Written Standards and Compliance Learning members to facilitate the 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 for a process to ensure its integrity and simplicity are maintained, escalating any issues that require higher level governance involvement.
Proactively seek feedback to continually improve service levels through innovation and increased efficiency in the development and delivery of processes and documents.