GlaxoSmithKline Looking for Computer Compliance Audit Manager at Durham, NC  Full Time

Are you an experienced Computer Compliance Quality Assurance Professional looking for a challenging opportunity to leverage your expertise to assist GSK Senior Management in the identification, prioritization and monitoring of quality, compliance and technical risks? If so, this role within our Quality Audit and Compliance organization could be a great position for you to explore.

We currently have an opportunity for a Computer Compliance Quality Audit Manager to join our team here at GSK. The Computer Compliance Quality Audit Manager is responsible The Computer Compliance Quality Audit Manager is responsible for evaluating the level of compliance with the GSK Quality Management System for the manufacture and supply of products and local regulations for the markets supplied for the following auditee types:

• GSK Pharma and Vaccine manufacturing sites

• IT Software Application Suppliers

• Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS) providers supporting GxP activities for GSK Global Supply Chain

• 3rd Party Service Suppliers providing services associated with Application Development & Maintenance services and Business Process Outsourcing associated high risk GxP systems utilized by Global Supply Chain

• Software as a Medical Device (SaMD) audits.

Your excellent communication and influencing skills will be a key deliverable for success in the role.

Travel: Approximately 40 to 50% travel is required.

In this role you will…

• Prepare, conduct, and manage GMP compliance audits of scheduled auditees utilizing a risk-based approach to determine audit scope and depth.

• Liaise with Site Quality Directors, External Supply Operational Quality, Global Computer System Validation, and other stakeholders to agree GMP audit dates.

• Ensure effective audit preparation, audit conduct and reporting.

• Identify and document site gaps to GSK Quality Management System and applicable cGMP requirements.

• Preparation of clear concise audit reports that ensure senior management is apprised of the identified risks and that appropriate corrective action plans are implemented.

• Expand knowledge base through proactive knowledge sharing and collaboration.

• Drive continuous improvement of audit systems and processes.

In addition:

• Manage the interface with auditees and stakeholders (the latter may include Site Directors, Site Quality Directors, Manufacturing & Quality Directors of 3rd Party Service Suppliers).

• Communicate learning points through Quality Alerts.

• Promote early visibility of regulatory / compliance issues.

• Provide input to Global QMS Documents and Audit function SOPs / GUIs.

• Develop self and others through giving and receiving feedback to promote excellence and continuous improvement (e.g. peer review of reports, support GSK Auditor Certification Process as trainer or interviewer).

Additionally, more experienced staff may undertake:

• Management of the interface with senior stakeholders, including regional Supply Division Heads, regional Quality Operational Heads and Cluster Leads, Heads of Support Functions and PSC R&D Quality.

• Management of large elements of the audit process with minimal direction from the Audit Director.

• Lead multi-departmental projects.

• Perform review/ approval of audit documents as a delegate.

Typical work output will involve:

• Entity internal audits of GSK Pharma and Vaccines manufacturing sites

• Entity external audits of IT Software Application Suppliers, and 3rd Party Service Suppliers

• Entity external audits of Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS) providers supporting GxP activities.

• Entity external audits 3rd Party Service Suppliers

• Software as a Medical Device (SaMD) audits.

• For Cause audits based on identified risks or regulatory actions

• Progress audits against risk mitigation plans or regulatory citation commitments

• Clear, concise and objective audit reports that ensure senior management is apprised of the identified risks and that appropriate corrective action plans are implemented.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science degree in Information Technology and/or engineering discipline.

• Demonstrable Vaccines/Steriles subject matter expertise (or a technically similar discipline). For example, extensive experience in the pharmaceutical industry including specifically in Vaccines / Steriles related industries.

Preferred Qualifications/ Experience

If you have the following characteristics, it would be a plus:

• Broad based understanding of pharmaceutical manufacturing.

• Previous Experienced in computer system validation activities, developing and implementing validation program for IT, analytical instruments and manufacturing control systems for Biologics/Pharmaceutical manufacturing processes.

• Experienced in conducting external Computer Compliance audits from Software as a service SaaS and Software as a Medical Device (SaMD) providers.

• A working knowledge and competency in evaluation of ALCOA+ principles within the pharmaceutical industry.

• Excellent written, verbal, questioning, and listening skills.

• Ability to utilize critical thinking of complex quality systems and processes.

• Auditor accreditation/certified either through the GSK internal Auditor Certification Program (or progressing through GSK’s ACP program) or via an external certified body.

• Experience managing the interface with stakeholders (Site Directors, Site Quality Directors, Heads of Support Functions).

• Understanding and experience of corporate governance processes.

• Understand or have a background in New Product Introduction requirements.

• Risk Management knowledge, application and evaluation.

• Application of continuous improvement change control and risk assessment.

• Reading and verbal multiple language communication skills is considered an advantage.

• Experienced in performing system life cycle audits with respect to FDA validation and part 11 requirements and pharmaceutical and medical device industry practice.

• Experienced in conducting external Computer Compliance audits from Software as a service SaaS and Software as a Medical Device (SaMD) providers.

• Experience with and good knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for Vaccines, Biopharmaceuticals and Pharmaceuticals.

• Experience identifying and/or managing quality and compliance risks.

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Why Us?

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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