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    Compliance Solutions Lead - King of Prussia, United States - GlaxoSmithKline

    GlaxoSmithKline
    GlaxoSmithKline King of Prussia, United States

    3 weeks ago

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    Description

    Site Name:
    Upper Merion, UK - Essex - Harlow, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence

    Posted Date:

    May 6 2024With increasing needs in Quality, Compliance, and Safety, the harmonization, simplification and acceleration of work processes and systems will deliver critical benefits to ensure delivery of the future portfolio for GSK.

    Supporting R&D, we are a cross-functional team with deep expertise in the Quality Management System, risk management, safety, compliance, deviation management, training, documentation, and data management.

    This department plays a critical role in developing our compliance strategies, transforming our technical capabilities, and driving our Quality culture, all while ensuring we maintain our License to Operate.

    As Compliance Solutions Lead you will be responsible for ensuring that the Medicine Development and Supply (MDS) organization is in a compliant state with respect to regulations and GSK policies/procedures, while building a strong compliance culture in the organization.

    The holder will work effectively in a matrix across business functions to ensure that compliance requirements are clearly identified and understood, risks are proactively managed and mitigated, problems are rapidly and thoroughly investigated, and best practices are established.

    This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the followingDesigning and continuously improving compliance processes that will impact MDSRecommending and implementing effective and sustainable solutions across the business linesBeing the change champion in driving compliant and effective solutions/embedding ways of workings across teams and business linesIdentifying compliance approaches and strategies which will ensure a now and future-ready organizationMeasuring the performance of the MDS organization and using this data to proactively identify issues, mitigate risks, and generate solutions which improve compliance and efficiencyLeading teams/sub-teams and supporting investigations, activities, or risk mitigation actions in areas of expertisePresenting to internal R&D forumsSpecific accountabilities may include:Leading data analysis and trending for key metrics, detecting and highlighting signals through the appropriate escalation channelsParticipating in appropriate Tiered Quality Councils and/or Risk Councils, including generation and analysis of data, with a focus on proactive monitoringAuthoring/reviewing SOPs and other documents necessary to support the Quality Management SystemSupporting internal/external audits, including serving as Subject Matter Expert of the respective disciplineDriving Quality Culture initiatives within the MDS organizationWhy you?

    Basic Qualifications:

    We are looking for professionals with these required skills to achieve our goals:Bachelor's Degree with 3+ years' experience in GxP processes supporting drug development and/or supply.

    Experience in compliance requirements (external and/or within GSK) in operational compliance/product quality. Specifically, knowledge of the Internal Control Framework, external regulatory requirements regarding data (e.g. data integrity, ALCOA CCEA), and risk management.

    Experience in various IT systems/solutionsExperience analyzing data to measure and monitor compliance and drive continuous improvementExperience working in a matrix team.


    Preferred Qualifications:

    If you have the following characteristics, it would be a plus:Excellent communication (written and verbal) skillsAbility to be a champion of change within an organization and embed new ways of working.

    Ability to closely monitor and communicate progress on daily tasks. Ability to escalate issues and recommendations to management for discussion in a timely manner.
    Ability to understand needs of customers/stakeholders and develop solutions.

    Experience leading a global matrix team to deliver business relevant compliance solutionsExperience managing scale and complexity across an organization, driving effective ways of working, interaction, and connectivity, and ensuring delivery through systems, processes, and peopleAttention to detail, with the ability to operate at both a detailed and summary level, and to put data analysis into context by seeing the bigger picture, to spot trends and extrapolateAbility to thrive in a fast-paced environment with potential for significant change#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

    Why 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, its 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.
    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.

    This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

    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 GSKs compliance to all federal and state US Transparency requirements.

    For more information, please visit GSKs Transparency Reporting For the Record site.#J-18808-Ljbffr
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