Case Management Group Quality & Compliance Director, Open to flexible working
The key purpose of this role is to drive the reduction of organizational risk associated with the outsourcing of the processing of HSI. The position holder will ensure that case processing activities align with GSK standards for processing HSI and that regulatory timelines are achieved by managing the quality measurement system for oversight and training of the vendor. This position holder will play a key visible role to ensure that GSK regulatory and reputational risk is minimized.
- This position holder manages a team of scientific staff responsible for managing the quality and compliance of case management processes and regulatory submission activities for HSI from all sources.
- The position holder is responsible for setting strategy, coordinating workload and allocating resources within their functional area. This role is responsible for advancement of methodology and process improvement initiatives that impact Safety & Pharmacovigilance. This role works across a matrix environment.
- Accountable to build internal and external relationships with key stakeholders and senior leaders to ensure delivery of a robust quality and compliance management system related to case management activities
- Manages a team of scientific staff responsible for the quality and compliance oversight of third party/parties responsible for processing GSK HSI from all sources; includes accountability for risk management and management monitoring oversight
- Works across a complex matrix environment (across all business units) to drive high quality delivery of case management quality and compliance activities that comply with internal standards and external regulatory requirements
- Contributes to advancement of the broader CSD business strategy and implementation of new initiatives in the functional team
- Where problems or issues are identified, leads investigation into root cause and ensures appropriate oversight and implementation of corrective/preventative actions (CAPAs)
- Primary contact for audits, inspections and oversight of CAPAs specific to case management activities
- Accountable for the development, preparation and reporting of metrics for monitoring case quality and regulatory reporting compliance, including determining Key Performance / Risk Indicators for case management activities.
- Accountable for ensuring implementation of the Internal Control Framework (ICF) in the case management process
The job holder needs to be tenacious and have a strong performance mindset - driving for results through an understanding of drivers of the business and has an ability to focus on the things that make a difference and get things done. To achieve this the job holder needs to have:
- BS/BA in a scientific or medically-related field, plus experience in the pharmaceutical industry in pharmacovigilance, clinical development and information management. Equivalent work experience considered.
- Significant pharmacovigilance/clinical safety and/ or related experience
- Substantial management experience
- High level of clinical understanding
- Excellent oral and written communication skills
- In-depth knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, clinical safety documentation, reporting of adverse events from clinical trials and spontaneous sources, local regulatory requirements, and pharmacovigilance methodology; understanding of world-wide Pharmacovigilance regulatory requirements
- Knowledge of the drug approval process in major markets
- Working knowledge of principles of data collection, manipulation and retrieval
- Experience in change management within CSD and LOCs to drive forward new initiatives
- Good knowledge of medical and drug terminology
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, rigor 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.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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