R&D Process Excellence Director
GSK
6 months ago
Remote friendly (Collegeville, PA)
United States
Operations
Key Responsibilities:
- Create strategy with Process Owners to define each process’ information package and secure required SME resources to simplify and deliver it.
- Lead projects to develop or revise SOPs, templates, how-to guides, and related communication materials for process (or change) information packages, ensuring on-time, high-quality delivery.
- Lead functional area input (e.g., learning developers, learning systems experts); author documents as needed and efficiently run comments resolution and evaluation meetings while ensuring consistent writing style, detail level, and documentation standards.
- Drive Process Owners and SMEs to develop and approve simple, clear process documentation (including associated training) that supports compliance with relevant laws and regulations.
- Challenge SMEs on appropriate level of detail to ensure documents are effective for users.
- Identify and resolve overlaps/interactions within the process landscape.
- Ensure impact assessments are performed and mitigation actions are completed.
- Collaborate to improve accessibility of documentation through a one-stop-shop.
- Partner with Quality and others to govern documentation integrity and simplicity; escalate governance issues as needed.
- Proactively seek feedback to improve service levels through innovation and efficiency.
Basic Qualifications:
- Bachelor’s Degree in Life Sciences or Scientific discipline.
- Pharmaceutical R&D experience.
- Experience authoring procedural documents, document management, and/or medical writing.
- Working knowledge of drug development processes and regulatory requirements.
- Matrix management, influencing beyond authority, and project leadership.
- Stakeholder management and business partnering experience.
Preferred Qualifications:
- Lean Sigma/operational excellence, problem solving/root cause, leadership.
- GLP/GxPs knowledge.
- Process design/process mapping familiarity; quality mindset.
- Ability to simplify the complex without losing meaning.
- Ability to quickly build credibility/trust and highly developed influencing skill.
- Create strategy with Process Owners to define each process’ information package and secure required SME resources to simplify and deliver it.
- Lead projects to develop or revise SOPs, templates, how-to guides, and related communication materials for process (or change) information packages, ensuring on-time, high-quality delivery.
- Lead functional area input (e.g., learning developers, learning systems experts); author documents as needed and efficiently run comments resolution and evaluation meetings while ensuring consistent writing style, detail level, and documentation standards.
- Drive Process Owners and SMEs to develop and approve simple, clear process documentation (including associated training) that supports compliance with relevant laws and regulations.
- Challenge SMEs on appropriate level of detail to ensure documents are effective for users.
- Identify and resolve overlaps/interactions within the process landscape.
- Ensure impact assessments are performed and mitigation actions are completed.
- Collaborate to improve accessibility of documentation through a one-stop-shop.
- Partner with Quality and others to govern documentation integrity and simplicity; escalate governance issues as needed.
- Proactively seek feedback to improve service levels through innovation and efficiency.
Basic Qualifications:
- Bachelor’s Degree in Life Sciences or Scientific discipline.
- Pharmaceutical R&D experience.
- Experience authoring procedural documents, document management, and/or medical writing.
- Working knowledge of drug development processes and regulatory requirements.
- Matrix management, influencing beyond authority, and project leadership.
- Stakeholder management and business partnering experience.
Preferred Qualifications:
- Lean Sigma/operational excellence, problem solving/root cause, leadership.
- GLP/GxPs knowledge.
- Process design/process mapping familiarity; quality mindset.
- Ability to simplify the complex without losing meaning.
- Ability to quickly build credibility/trust and highly developed influencing skill.