Global Director, Process Management - GMASE
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Global Director, Process Management - GMASE
GSK’s success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s 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.
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Position Summary
The Global Director Process Management – GMASE will be accountable for overseeing and optimizing assigned end-to-end business processes within 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 GSK’s strategic goals.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of these end-to-end processes. Ensure these processes are aligned with GCO’s strategies, consider innovative approaches being developed in the industry, drive efficiency, comply with regulatory requirements 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 changes 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.
Act as a change agent, effectively communicating and managing change initiatives to minimize disruption and maximize buy-in from stakeholders.
Provide expertise and represent the process in different cross business process work streams or be the work stream lead when relevant.
May take additional initiatives to support Clinical Operations function and GSK.
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 processes 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 GCO’s 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.
May act as mentor to more junior staff.
Internal candidates will ideally be based in GSK hubs, Canada (Mississauga), United Kingdom (London HQ), United States (Collegeville, PA), Poland (Warsaw) and Belgium (Warve). Preference will be given to candidates located in these hubs, but candidates located near other GSK clinical operations (GMASE) sites will be considered.
Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelor’s degree in Scientific discipline.
Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Operational Excellence, or a related field (minimum of 8+ years in various roles with proven accountability across multiple countries/regions).
Excellent understanding of clinical operations processes, and ICH/GCP and global regulatory guidelines and health authority expectations for drug development and approval processes with specific expertise in RBQM, informed consent, clinical trial supplies and distribution of clinical safety documents for both medicine and vaccine clinical trials.
Experience leading major projects to completion and driving cross-functional, operational improvements and innovation.
Strong strategic and critical thinking, problem solving, influencing, negotiation, and decision-making capabilities.
Demonstrated matrix team leadership, effectively navigating complexity to deliver results.
Effective communication skills with ability to communicate and influence internal and external stakeholders, including Health Authority Inspectors.
Ability to travel internationally, if required
Ability to comply with GSK’s performance with choice policies, requiring regular office presence to foster collaboration and team alignment.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
Advanced degree in Scientific discipline
Demonstrated business acumen with a forward-thinking and visionary mindset to modernize clinical processes, leveraging technology, digital analytics and data-driven insights to drive digital transformation initiatives to optimize clinical trial operations and improve overall efficiency.
Demonstrated cross-functional collaborator with experience in building networks of partners/stakeholders and broadly engaging with expert communities internal and external to GSK.
#LI-GSK
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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- Location:
- Montgomery County
- Job Type:
- FullTime