Senior Advisor Computer Systems QA

Poznań, wielkopolskie
Stała
Pełny etat

22 dni temu

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 or lead 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.
Lead and participate 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 or lead improvement processes, as needed, and set specific measurable targets and goals linked to CSV QA/QuRE/GSK business needs.
Contribute to, or lead the training, education, guidance and influencing of GSK R&D (Research & Development) staff on best practices and quality and computer compliance policy.
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
Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments.
May have direct\indirect reports
Identify and 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.
Consult with Manager with any questions, concerns, or project related risks.
Any other duties relevant to, and consistent with, the job's level of responsibility, as required by CSV QA management.

Basic Qualifications:

Experience of the regulated pharmaceutical industry and computer compliance regulations and expectations
Ability to build and maintain effective internal GSK business relationships within QuRE and business units.
Demonstrated hands on implementation (3-5 years), of computer systems in an applicable industry. Experience with standards in the software development lifecycle model, aligning with the Quality and Regulatory expectations for the pharmaceutical 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 most levels and may interact with regulators. Build and maintain effective internal GSK business relationships within GQA and business units.

Benefits:

Career at one of the leading global healthcare companies
Attractive reward package (competitive salary, annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit
Possibilities of development within the role and company’s structure
Life insurance and pension plan
Open and inclusive environment which is supportive and welcoming of all diversity strands (gender, race, ethnicity, sexuality, disability, or any other characteristic)
Private medical package with additional preventive healthcare services for employees and their eligible counterparts
Sports cards (Multisport)
Personalized learning approach and external trainings
Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities)
Supportive community and integration events
Modern office with creative rooms, fresh fruits everyday
Free car and bike parking, locker rooms and showers

#LI-GSKG7Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at

GlaxoSmithKline

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