GlaxoSmithKline
Small Molecule R&D Quality Director
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
UK - London, Belgium-Wavre, Singapore - Tuas, UK - United Kingdom, USA - Pennsylvania - Upper Providence, WarePosted Date:
Sep 5 2024Job purpose:As the Small Molecule R&D Quality Director, you perform the quality assurance activities and quality oversight of the GMP functions performed within Small Molecule R&D, essentially related to the manufacturing of clinical material.Your responsibilities:Develop and implement strategy, policy and group objectives that build competency in operational excellence in quality assurance of clinical products.Are accountable for building continuous improvement into the processes and ways of working to optimize end to end quality and right first time.Interact with regulators and/or industry experts to represent GSK interests.Are responsible for leading the team in a dynamic matrixed environment by setting standards, objectives and measurements to drive business results and build a performance based culture.Manage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives.Are responsible for analysis, assessment, management, and communication of inherent and emerging risks to GSK management.Are responsible for the detection, communication and escalation of risks, and subsequent management of mitigation actions.Are accountable for team of global Quality Assurance managers, will motivate, focus and develop the team in an inclusive environment to build a high performing team.Are responsible for representing Quality R&D, providing relevant information to governance boards and one voice of GSK internally and externally.Are responsible for the timely release of material for clinical studies.Ensure a robust GxP training program, that appropriate qualification, validation and change control activities are undertaken within business partner areas.Are responsible for quality oversight, ensuring robust quality management systems are in place.Additional information:Reporting line: Head of R&D GMP Quality DirectorNumber of positions available: 1People management (direct/indirect reports, etc.): approx. 10 direct reportsBusiness travel requirements: 10%Primary location: Ware, UKSecondary locations: Upper Providence (US), Wavre (BE) or Singapore - Applicants should be based in or close to these locations with a valid local visa/work permit.Why You?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Minimum BA/BS degree in Science or Engineering or equivalent in experienceMinimum 10 years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA)Minimum 5 years of experience in a quality management roles in manufacturing or analytical testing and releaseDemonstrate knowledge of technical and operational domains within an R&D changing environment e.g. small molecules API and DP manufacturingAbility to lead, influence and negotiate at all levels within the organizationAbility to ensure a consistent approach in the interpretation and implementation of GMP/GDP standardsProblem solving and negotiation skillsAbility to evaluate riskAbility to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interestFluency in English both written and spokenPreferred Qualifications:If you have the following characteristics, it would be a plus:Master's or PhD in Science or EngineeringInterpersonal skills with demonstrated ability to engage, empower and influence peopleUnderstanding of cGMP and regulations applicable to GSK in the relevant countries (FDA/EU/WHO and other countries)Ability to evaluate product/technical compliance and quality issues and make sound recommendations regarding problem resolutionAbility to drive change and continuous improvementAbility to work transversally in matrix organization, with global perspectivesAbility to make independent decisions even under pressure and navigate in grey zonesAbility to communicate complex information both orally and in writingAbility to adapt, work under uncertainty and accommodate flexible work demands.Application closing date:
Sunday 15 September, 2024 EOBPlease take a copy of the Job Description, as this will not be available post closure of the advert.#LI-GSKWhy GSK?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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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UK - London, Belgium-Wavre, Singapore - Tuas, UK - United Kingdom, USA - Pennsylvania - Upper Providence, WarePosted Date:
Sep 5 2024Job purpose:As the Small Molecule R&D Quality Director, you perform the quality assurance activities and quality oversight of the GMP functions performed within Small Molecule R&D, essentially related to the manufacturing of clinical material.Your responsibilities:Develop and implement strategy, policy and group objectives that build competency in operational excellence in quality assurance of clinical products.Are accountable for building continuous improvement into the processes and ways of working to optimize end to end quality and right first time.Interact with regulators and/or industry experts to represent GSK interests.Are responsible for leading the team in a dynamic matrixed environment by setting standards, objectives and measurements to drive business results and build a performance based culture.Manage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives.Are responsible for analysis, assessment, management, and communication of inherent and emerging risks to GSK management.Are responsible for the detection, communication and escalation of risks, and subsequent management of mitigation actions.Are accountable for team of global Quality Assurance managers, will motivate, focus and develop the team in an inclusive environment to build a high performing team.Are responsible for representing Quality R&D, providing relevant information to governance boards and one voice of GSK internally and externally.Are responsible for the timely release of material for clinical studies.Ensure a robust GxP training program, that appropriate qualification, validation and change control activities are undertaken within business partner areas.Are responsible for quality oversight, ensuring robust quality management systems are in place.Additional information:Reporting line: Head of R&D GMP Quality DirectorNumber of positions available: 1People management (direct/indirect reports, etc.): approx. 10 direct reportsBusiness travel requirements: 10%Primary location: Ware, UKSecondary locations: Upper Providence (US), Wavre (BE) or Singapore - Applicants should be based in or close to these locations with a valid local visa/work permit.Why You?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Minimum BA/BS degree in Science or Engineering or equivalent in experienceMinimum 10 years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA)Minimum 5 years of experience in a quality management roles in manufacturing or analytical testing and releaseDemonstrate knowledge of technical and operational domains within an R&D changing environment e.g. small molecules API and DP manufacturingAbility to lead, influence and negotiate at all levels within the organizationAbility to ensure a consistent approach in the interpretation and implementation of GMP/GDP standardsProblem solving and negotiation skillsAbility to evaluate riskAbility to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interestFluency in English both written and spokenPreferred Qualifications:If you have the following characteristics, it would be a plus:Master's or PhD in Science or EngineeringInterpersonal skills with demonstrated ability to engage, empower and influence peopleUnderstanding of cGMP and regulations applicable to GSK in the relevant countries (FDA/EU/WHO and other countries)Ability to evaluate product/technical compliance and quality issues and make sound recommendations regarding problem resolutionAbility to drive change and continuous improvementAbility to work transversally in matrix organization, with global perspectivesAbility to make independent decisions even under pressure and navigate in grey zonesAbility to communicate complex information both orally and in writingAbility to adapt, work under uncertainty and accommodate flexible work demands.Application closing date:
Sunday 15 September, 2024 EOBPlease take a copy of the Job Description, as this will not be available post closure of the advert.#LI-GSKWhy GSK?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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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