Associate Director, Quality Auditor

GlaxoSmithKline

300d

About The Position

The purpose of this role is to provide independent Quality Assurance within GSK R D by delivering comprehensive audit programs. This role will define audit scope and methodology to conduct audits and ensure the delivery of audit reports. 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. The role occupant (employee) is primarily aligned to preclinical Good Laboratory Practice (GLP) & secondarily with Good Clinical Practice (GCP) laboratories and is suitably qualified by training and/or experience to perform the relevant QA responsibilities as outlined in this job description.

Requirements

• Bachelor's degree in scientific or quality-related field.
• 5+ years' experience in pharmaceutical industry and/or quality assurance.
• 8 + years' expertise in GLP and GCP laboratory regulatory requirements.
• Experience in risk management, specifically as it applies to audit management and oversight of R D areas and third parties.
• Experience in developing learning tools utilizing new technology or concepts.

Nice To Haves

• Experience in leading regulatory authority inspections.
• Experience and knowledge covering two or more Regulatory areas 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.
• Proven excellent verbal, written communication and presentation skills.
• Excellent interpersonal skills, and ability to work in the matrix across geographical and organizational boundaries.
• Demonstrated analytical, organizational and planning skills.

Responsibilities

• Lead in the development, management, and implementation of strategies, and initiatives to support 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.
• Independently manage comprehensive 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 complex 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.
• Lead functional initiatives as assigned.
• Ability to lead key process improvement initiatives from design to implementation and continuous improvement.
• Generate and interpret metrics and trend reports to identify trends and opportunities for improvements across the business.
• Act as inspection coordinator for related regulatory authority inspections of GSK.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree