As a Manager, CSQA, you will participate in projects delivering computer systems within the regulated areas of Pharma R&D and Vaccines. You will conduct computer system validation related audits to ensure compliance within GSK and external to GSK. You will also support regulatory agency inspections of Pharma R&D and Vaccines to achieve successful outcomes. All of this will be done to ensure GSK R&D and Vaccines compliance and inspection readiness with respect to applicable Pharmaceutical Regulatory Agency requirements for Computerized System Validation (CSV), Regulated Electronic Records and Signatures (RERS), Regulated Electronic Data Integrity (REDI) and GSK controls.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Why you? Basic Qualifications:
- 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.
- Conduct routine computer compliance audits (internal & external)
- 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%
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 5-7 years experience.
- Computer System Validation experience (5+ years) - either conducting CSV or from a quality assurance perspective.
- Experience with Software Development Life Cycle (SDLC) principals including planning, analysis, design, development, testing, implementation, and maintenance.
If you have the following characteristics, it would be a plus:
- Experience interacting with regulators either through regulatory inspections or via industry groups.
- 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
- 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)
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
*LI-GSK *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 impact the health of 2.5 billion people around the world in the next 10 years.
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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