Advisor, Computer Systems QA

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

KEY RESPONSIBILITIES:

• Represent CSV QA as a business contact.
• Execute effective processes and procedures in CSV QA & QuRE and may contribute to business processes and procedures outside QuRE.
• Ensure computer systems meet regulatory requirements and that they conform to regulatory expectations.
• Represent CSV QA and participate in the review and approval of computer system validation documentation throughout the lifecycle of an application.
• Review and approval of change requests through to closure of computerized systems and infrastructure as applicable.
• May interact with regulators during regulatory inspections and provide relevant documentation as required.
• Support routine computer compliance vendor audits (internal & external) as well as computer compliance initiatives.
• Participate and collaborate in CSV QA initiatives, programs, or team activities, as required.
• Identify and mitigate computer related business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
• Contribute to improvement processes, as needed, and set specific measurable targets and goals linked to CSV QA/QuRE/GSK business needs.
• Contribute to the training, education, guidance and influencing of GSK R&D (Research & Development) staff on best quality and computer compliance policy and practices.
• Ensure compliance with computer compliance regulations and expectations in alignment with GSKs related policies and procedures.
• Eliminate regulatory risk to GSK facilitating the right level of validation activities necessary to deliver the solution to industry standards and regulatory requirements
• Mitigate computer compliance risks to GSK via providing advice and consultancy to project teams and business units regionally and globally within R&D
• Maintain awareness of, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments.
• Any other duties relevant to, and consistent with, the job's level of responsibility, as required by CSV QA management.

Basic Qualifications:

• Demonstrable knowledge/awareness of the regulated pharmaceutical industry and computer compliance regulations and expectations
• Participation in hands on implementation (1-2 years at a minimum), of one phase of the CS (Computerized Systems) lifecycle of applicable industry standards in the software development lifecycle model, aligning with the Quality and Regulatory expectations for the industry.
• Communications are clear, concise, well structured, authentic, and easily understood. Communicates and interacts at most levels both inside and outside of GSK.
• May influence and negotiate at various levels within the organization.
• Build and maintain effective internal GSK business relationships within QuRE and business units.

Benefits:

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach
• Extensive support of work life balance
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers.

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Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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