Do you enjoy collaborating with stakeholders and partners to help ensure compliance with company policies, procedures, and regulations related to computer system validation, electronic records and signatures, and data integrity? If so, this Associate Director, Computer Systems QA opportunity could be an exciting opportunity to consider.Job Purpose
As an Associate Director/Manager CSQA, you will lead projects from a QA perspective, aligning with industry standard current best practices, delivering compliant, regulatory acceptable computer systems within the regulated areas of Pharma R&D and Vaccines. You will conduct computer system validation related audits to ensure regulatory compliance external to GSK and leverage third party activities supporting 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), Electronic Records and Signatures (ERES), Data Integrity (DI) 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 industry and regulatory requirements conforming to regulatory expectations.
- Proven ability to make sound decisions. In doing so, you will use a range of sources and weigh benefits and risks before making important decisions, using all available sources of information before making important decisions, seeking support and endorsement as necessary.
- 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 of external suppliers
- Manage CSQA priorities, schedules and/or initiatives to assure delivery of CSQA, GQA & GSK objectives.
- Lead CSQA initiative, program, or team activities, as required.
- Demonstrate a constant focus on improving performance and excellence in all tasks.
- Challenge and question ways of working to seek improved processes.
- Raise levels of performance by establishing or improving processes.
- Demonstrated capability of developing and recommending strategies for change and explaining to customers the rational for change.
- Educate, guide and influence GSK management and staff on best quality and compliance practices, as they relate to areas of identified responsibility”
- 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. Represent CSQA across GSK and externally
- Work closely with Information Technology department, system owners and business owners providing rationale for your position with data/precedent/guidance.
- 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 10-12 years' experience.
- Computer System Validation experience (8+ years) - either conducting CSV or IT systems implementation from a quality assurance perspective.
- Proven Long term Performance Record
- 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 and consider broader risks beyond pure compliance and/or cross-GxP risks.
- Demonstrated capability of developing and recommending strategies for change and explaining to customers the rationale for change.
- Ability to influence and negotiate at various levels internal and external to GSK.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
- 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
- Ability to think beyond the standard validation implementation approach, right sizing the approach and deliverables to align with a risk-based process dependent upon the intended use of the system.
- Extensive knowledge of regulatory requirements and the differences across GLP, GCP, GMP, GPV implementing Computer Systems within these areas.
- Experience in leading the validation approach of systems or platforms from a regulatory strategy following current industry standards and current regulatory requirements.
- Proven ability to propose creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
- Recognizes and escalates potential long-term risks for projects/products.
If you have the following characteristics, it would be plus:
- Experience interacting with regulators either through regulatory inspections or via industry groups.
- Experience and practical understanding GAMP and ERES standards
- Understanding of Software as a Service (SaaS) and associated compliance concerns.
- Understanding of Platform as a Service (PaaS), Infrastructure as a service (IaaS).
- 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
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. As 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. We are embracing digitization poised to be best in class implementing new technologies.
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.
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