Manager CSQA

Responsibilities:

• Conduct routine computer compliance audits (internal & external)
• Provide input into the development of strategy, policy, CSQA objectives and processes in Global Quality Assurance and with business partners.
• Assure computer systems meet regulatory requirements and that they conform to regulatory expectations.
• Interact with regulators and/or industry experts to represent GSK interests.
• Interpret and apply regulations/policies to unique and often complex issues.
• Interpret and communicate changes in the regulatory environment that could impact GSK to proactively mitigate and resolve potential computer compliance issues. Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance across Pharma R&D and Vaccines.
• Manage computer compliance initiatives of demanding high priority including regulatory inspections and high-risk non-compliance issues (ex. lack of supporting evidence of validation).
• Manage CSQA priorities, schedules and/or initiatives to assure delivery of CSQA, GQA & GSK objectives.
• Lead CSQA initiative, program, or team activities, as required. Contribute to an environment that optimizes employee productivity and adds value.
• May develop group skill sets and knowledge base to meet the needs of a changing environment.
• Actively engage in computer compliance risk management activities to identify effective risk management strategies for identified risks. Proactively share potential computer compliance risks to the business to initiate mitigating measures.
• Act as coach/mentor to develop others with CSQA/GQA
• Represent CSQA as a primary business contact. May represent CSQA across GSK and externally
• Provide suitable recommendations/mutual solutions that show measurable improvement and added value to internal/external customers with respect to emerging technology as well as established solutions.
• Work closely with Information Technology department, system owners and business owners to effectively and efficiently implement new systems, system upgrades, or system modifications.
• Ability to travel up to 15%Q

Why you?

Basic Qualifications:

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

• University Degree in the Life Sciences or Computer Science field OR equivalent 5 or more years experience.
• Computer System Validation experience (5 years) – either conducting CSV or from a quality assurance perspective.
• High degree of organizational awareness and in-depth knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations (FDA, MHRA, etc.).
• Ability to understand and consider broader risks beyond pure compliance and/or cross-GxP risks.
• Ability to influence and negotiate at various levels internal and external to GSK.
• Work independently and engage with business areas in strategic and/or operational decisions on behalf of Computer Systems QA.
• Develop internal and/or external networks to influence key stakeholders
• Knowledge of Software Development Life Cycle (SDLC) principles including planning, analysis, design, change control review and approval, development, testing, implementation, data migration, maintenance and system retirement.

Preferred Qualifications:

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

• Experience interacting with regulators either through regulatory inspections or via industry groups.
• Experience and practical understanding of Data Integrity Principles (e.g. ALCOA ) and associated assessments
• Experience delivering practical and effective broad topic and focused education to a diverse stakeholder group
• Experience and practical understanding GAMP and ERES standards
• Understanding of Software as a Service (SaaS) and associated compliance concerns.
• Understanding of automation and its use in computer system validation (automated testing for example)
• Knowledge of artificial intelligence and machine learning
• Understanding of the use of cloud computing in the pharmaceutical space
• Understanding of Platform as a Service (PaaS)
• Experience with Quality Agreements
• Experience with Supplier Assessments and Third-Party interactions

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

• This is a job description to aide in the job posting, but does not include all job evaluation details.

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 organisation 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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