Senior Investigation Team Member- Hybrid (336525)
This role ensures that Medicine Development and Supply is in a compliant state with respect to regulations and GSK policies/procedures. The holder will participate in the robust and timely investigation and recording of deviations across MDS. They will assist with the identification of trends and will deliver inspection-ready investigation reports.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Leads complex or Critical deviations with the potential for direct impact on regulated systems or clinical supplies
- Provides support to the MDS lines by leading or facilitating the RCA process associated with deviations and Independent Business Monitoring (IBM)
- Supports Customer Complaints and Vendor Complaints as required by the business
- Provides support to other team members with less experience of Root Cause Analysis (RCA)
- Ensures the correct identification of root causes during investigations
- Documents the outcome in a clear and accurate manner
- Delivers robust outcomes to required timelines
- Effectively communicates and collaborates with lines in the management and delivery of investigations
- Contributes as Subject Matter Expert to the development of core business practices for the management of deviations, customer and vendor complaints
- Leads or supports training in the quality processes
- Contributes to trend analysis on past deviations to support recommendations for proactive interventions and improvements
- Drives a culture of simplification by recommending, collaborating, and implementing effective and sustainable solutions across the MDS lines
- Uses a thorough knowledge of compliance requirements (external and within GSK) to identify approaches and strategies which will ensure a compliant organization
- Leads matrix teams/sub-teams and supports significant investigations, activities, or risk mitigation actions in areas of expertise
- Contributes to the building of a compliance culture through the design and delivery of engagement communications, training, and activities
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in a scientific or related discipline
- Experience in leading and resolving complex deviations
- Experience delivering compliance outcomes through the application of expertise in deviation management
- Knowledge of the relevant pharmaceutical industry regulations
- Knowledge of the MDS business
If you have the following characteristics, it would be a plus:
- Proven ability to effectively assimilate and communicate compliance data to management for the purpose of driving corrective actions and mitigating risks
- Able to negotiate and influence during investigations
- Able to communicate and report clearly in an engaging and memorable way, tailored for targeted audiences
- Demonstrated ability to work in a matrix in order to deliver robust investigations
- Ability to collaborate both within department and beyond department as needed during investigations
- Proven ability to drive for results within agreed timeframes
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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