External Quality Small Molecule Regional Director

Job title:

External Quality Small Molecule Regional Director

Company

GlaxoSmithKline

Job description

Job purpose:As External Quality Small Molecule Regional Director you,Provide Quality leadership to the GSK supply network for our externally supplied pharmaceutical drug productsOversee and provide direction to a team of Quality Managers in maintaining and managing the quality of commercial supply (new and established performance products)Ensure inspection readiness activities for selected manufacturing sitesActively participate in the development and execution of the region quality strategy for the GSK external and supplier networkLead a team focused on the quality management of CMOs based in the regionLead the quality team in providing quality and compliance direction.Your responsibilities:Manage and develop an empowered team with necessary skills to support the current and future businessDevelop and deliver, through aligned group objectives, of a quality strategy for the assigned network in the Global Supply ChainEngage with CMOs (Contract Manufacturing Organizations) and set aligned goals through business review meetings and governance processesCompliance of assigned operations- both in terms of assured supply to patient and regulatory compliance (no interruption to supply)Interact with Regulatory authorities during inspections and/or through industry groups to represent GSK interestsEnsure on time delivery of NPIs and product transfers linked to their teamEnsure that our external network respond effectively to regulatory findings and product incidentsInterpret and apply regulations/policies to unique and often complex issuesLead and direct effectively in a dynamic matrixed environment by setting standards, objectives and measurements to drive business results and build a performance based cultureManage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectivesBuild an environment to optimize employee productivity and encourage the use of Continuous Improvement tools to add value to the organizationResponsible for assessment, communication and mitigation of inherent and emerging risks to GSK managementDesign and develop mutual solutions to issues that show measurable improvement on key indicators and added value to external/internal customers.Additional information:Reporting line: Director, External Quality Europe located in FranceNumber of positions available: 1People management (direct/indirect reports): yesGeographical scope: manage CMO network for small molecules outside EU and USPrimary location: Wavre, BelgiumSecondary location: EuropeApplication closing date: Monday July 15, 2024 EOBWhy You?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Minimum BA/BS degree level in Science e.g. Biology, Chemistry, Pharmacy or EngineeringMinimum 10 years of experience in Technical and Quality Operations in highly regulated marketsDemonstrate experience in pharmaceutical manufacturing and quality operationsKnowledge of regulatory requirementsUnderstanding of GMP’s, quality systems and quality control processesLeadership: you demonstrate strong influence, negotiation, communication skills, and are able to inspire, develop and motivate teams and coworkersPrioritize, plan and organizeMake risk- based decisionsManage across boundaries and demonstrate a high sense of cultural awarenessFluent in English both written and spokenPreferred Qualifications:If you have the following characteristics, it would be a plus:Master’s degree level or PhD in Science or EngineeringExperience in Quality Control, QP release or GMP auditingPlease take a copy of the Job Description, as this will not be available post closure of the advert.#LI-GSKIf you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.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, 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.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.

Expected salary

Location

Waver, Waals Brabant

Job date

Mon, 24 Jun 2024 23:10:41 GMT

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