Requirements: English
Company: GlaxoSmithKline
Region: Poznan , Greater Poland Voivodeship
Site Name: Warsaw Rzymowskiego 53, Bengaluru Luxor North Tower, Poznan Business Garden
Posted Date: Apr 1 2025
GSKs success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Job Purpose:
The Director Process Management will be accountable for overseeing and optimizing assigned end-to-end business processes within Global Clinical Operations (GCO) to drive efficiency, compliance, standardization, and continuous improvement across the organization. They will lead and work collaboratively with cross-functional teams to identify areas for process improvement & innovation, implement best practices, control process health & compliance, and ensure processes align with GSKs strategic goals.
Key Responsibilities:
The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs.
- As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of these end-to-end processes. Ensure these processes comply with regulatory requirements, are aligned with GCOs strategies, consider innovative approaches being developed in the industry, drive efficiency, and are well defined. Ensure that written standards are developed and maintained as needed to support the process and that written standards can be clearly understood by end-users. Provide necessary information and training to help users understand and implement these processes effectively.
- Define and implement process oversight strategy with key performance indicators, in-process controls, management monitoring and end-user feedback. Establish benchmarks and conduct periodic review of performance metrics to ensure effectiveness, efficiency, and compliance. Report process health and compliance to the relevant stakeholders proactively and take appropriate measures where deficiencies are identified.
- Influence and engage with the organization by building a strong network with stakeholders, partners, and subject matter experts to understand their drivers and needs along with broader organizational goals. Use these insights to craft alignment, drive meaningful change and improve end-user experience.
- Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs, manage risks or interdependencies, and implement improvements at scale.
- Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions. Partner with subject matter experts and support roles to deliver a comprehensive solution package that includes the end-to-end process itself, written standards, training, communication, change management, implementation, and monitoring plans.
- Maintain current knowledge of global regulations and guidance, global regulatory expectations, regulation intelligence and industry standards pertaining to the assigned processes. Proactively assess impact of any new regulations on assigned process and ensure ongoing compliance.
- Proactively educate themselves in evolutions and innovations across the industry and evaluate how they could positively benefit the effectiveness, efficiency or compliance of the process. Develop and align proposals with the appropriate stakeholders to drive process innovation that is aligned with GCOs strategic priorities and stakeholder needs.
- Maintain personal readiness to respond to internal audits and regulatory inspections, be the point of contact and interact with inspectors, and provide expert advice to respond to audit observations.
- Represent GSK in external forums to influence the external ecosystem in shaping industry-leading practices and development of innovative methodologies.
Basic Qualifications
- Bachelors degree in Scientific discipline.
- Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Operational Excellence, or a related field.
- Excellent understanding of clinical operations processes, and ICH/GCP and global regulatory guidelines for drug development and approval processes with specific expertise in informed consent, clinical trial supplies and distribution of clinical safety documents.
- Experience leadin