Site Name: Collegeville TSA, Durham Blackwell Street Posted Date: Nov 8 2024 Purpose of this role is to provide independent Pharmacovigilance (PV) Quality Assurance within GSK R&D by delivering comprehensive risk-based audit programs. This role will define audit scope and methodology to conduct audits and ensure the delivery of audit reports with and end-to-end process driven approach. This role involves identifying compliance issues, trends, within the scope of R&D to ensure compliance with relevant international regulatory agency regulations/guidelines, GSK policies/procedures and accepted principles and improving overall processes. Additionally, the role includes supporting QA activities during regulatory inspections, building solid working relationships with stakeholders, and maintaining knowledge of local regulatory frameworks and global regulatory reporting requirements. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Develop, manage, and implement strategies, and initiatives to support risk-based global quality assurance audit programs. Partner within the R&D Quality and Risk Management team to develop and deliver the risk strategy for the annual audit plan. Manage quality assurance programs and assess adherence to quality standards and compliance with international regulations and guidelines, and GSK policies and procedures. Independently plan, lead, and conduct different audit types of GSK processes and third parties to assess compliance with applicable regulations and guidelines, and GSK policies and procedures. Document objective and process-oriented audit findings in audit reports, and present findings to relevant stakeholders. Ensure robust CAPAs are obtained that address the findings, and their root causes. Support functional initiatives as assigned. Generate and interpret metrics and trend reports to identify trends and opportunities for improvements across the business. May act as inspection coordinator for related regulatory authority inspections of GSK. Collaborate with stakeholders to interpret international regulations and guidelines, and Regulatory Intelligence to establish and monitor compliance for (GSK) acceptable standards relating to audit activities. Provide expert advice in at least one area of expertise on compliance, quality improvement initiatives and risk assessments. Educate, guide, and influence stakeholders on best quality and compliance practices, especially in areas of identified responsibility. Responsible for training and providing feedback to peers. Maintains the highest level of awareness, expertise in international relevant regulations, and internal policies and SOPs. Aware of new technical skills and emerging technologies, and how they apply in processes in R&D Develop and maintain a network of contacts with other quality and compliance groups as well as stakeholder areas. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree Minimum of 3 years of experience in pharmaceutical industry in either Pharmacovigilance (PV) or PV Audit. Ability and desire for frequent domestic and international travel (up to 25%) Preferred Qualifications: If you have the following characteristics, it would be a plus: Demonstrated knowledge of at least one specific Regulatory area (as appropriate) and its regulatory requirements Demonstrated analytical, organisational and planning skills. Knowledge of risk management and risk-based thinking Ability to assess a process end-to-end. Demonstrated ability for good verbal, written communication and presentation skills. Good interpersonal skills, and ability to work in the matrix across geographical and organisational boundaries. Capable of being able to develop knowledge in new area utilizing new technology or concepts. Experience in supporting regulatory authority inspections. Experience and knowledge covering two or more Regulatory area e.g. GCP and GLP Broad knowledge of Risk-based quality management, root cause analysis and quality by design concepts and methodology Digital savviness, experience with AI/ML and data analytics Why GSK? 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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