The Pharmacovigilance (PV) Quality Auditor will provide Quality Assurance within GSK R&D by delivering comprehensive risk-based PV audit programs. This role will define audit scope and methodology to conduct audits and ensure the delivery of audit reports with an end-to-end process-driven approach. This role involves identifying compliance issues and 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.
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
In this role you will
* Develop, manage, and implement strategies and initiatives to support risk-based global quality assurance audit programs.
* Manage quality assurance programs and assess adherence to quality standards and compliance with international regulations and guidelines, and GSK policies and procedures.
* 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.
* Ensure robust CAPAs are obtained that address the findings and their root causes.
* 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.
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor's degree or equivalent in a scientific or quality-related field or equivalent combination of education, training, and experience.
* Experience in the pharmaceutical industry in either Pharmacovigilance (PV) or PV Audit.
* Ability and desire for frequent domestic and international travel (up to 25%).
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred; if you do not have them, please still apply:
* Demonstrated knowledge of at least one specific Regulatory area and its requirements, knowledge of risk management, quality management, and root cause analysis.
* Strong analytical, organizational, and planning skills, with the ability to assess processes end-to-end.
* Excellent verbal, written communication, and presentation skills, along with good interpersonal skills to work effectively in a matrix environment across geographical and organizational boundaries.
* Experience in supporting regulatory authority inspections.
* Experience and knowledge covering two or more Regulatory areas e.g. GCP and GLP.
* Digital savviness, experience with AI/ML and data analytics.
Closing Date for Applications - 19 Feb 2025 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology, and disease mechanisms, and transform medical discovery. We are revolutionizing the way we do R&D. We're uniting science, technology, and talent to get ahead of disease together.
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 organization 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. #J-18808-Ljbffr