Site Name: UK - Hertfordshire - Stevenage, UK – London – New Oxford Street
Posted Date: Feb 5 2025
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, 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.
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.
Basic Qualifications & Skills:
* Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
* 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 & Skills:
* 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 area 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.
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