Senior Manager Manufacturing Support > Boudry > Joboolo CH :
Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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Overseeing the Manufacturingsupport activities, the SeniorManagerManufacturingSupport provides leadership to his team which assist the Manufacturing Department.
He/She is responsible as an OSD process expert to participate in cross-functional investments and business process projects both in Bulk manufacturing, packaging and Warehouse activities.
He is also in charge of managing compliance activities related to deviations, CAPAs, and change control management.The SeniorManager OSD ManufacturingSupport works in close collaboration and alignment with his Manufacturing peers based at Boudry.
He/She also acts as deputy for his peer ManufacturingSeniorManager.
Skills/Knowledge RequiredMinimum Master’s Degree in Chemical Engineering, Engineering, Pharmacist or Natural Science.At least 10 years’ experience of previous supervisory experience in OSD pharmaceutical industry.Excellent technical/scientific skills and knowledge (knowledge of key pharmaceutical OSD unit packaging and bulk operations).Excellent change management and organizational skills.Demonstrated project leadership/management experience.
Experience of multi-site/cross-site project management (PMI, PMP certification desirable).Excellent working knowledge of compliance aspects, deviation management, CAPA and Change Control is a QA environment, cGMP and the Pharmaceutical Regulatory framework.Excellent leadership skills and ability to influence and work across organizational boundaries.Excellent verbal and written communication skills.
Fluent in French and English.Organized and rigorous, able to provide leadership and coaching to the ManufacturingSupport team in order to maintain an environment of trust and personal accountable.Demonstrated ability to effectively communicate with his team but also at all levels of the organizations.Experience in Lean Manufacturing/Six Sigma certification desirable.Excellent problem-solving ability.Experienced at presenting during regulatory audits (ie, FDA,SwissMedic).Ability to effectively utilize Microsoft Office Suite (MS Project, Excel, Word).
Duties and ResponsibilitiesFollow up, coordination and management of CAPAs, deviations and Change Controls within the support team.Initiate deviations, performs impact assessment, and participate to or lead on the floor investigations.
Partner with QA and Boudry Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
Coach and backup his team on performing initiation and initial impact assessment of quality events.
Initiate Change Controls, follow up actions and implementation as well as effectiveness.Perform complaint investigations.Lead or participate to site-related cross-functional projects and act as OSD SME (ie new validation process, technical transfer activities, Implementation of new equipment…).Initiate, own, and follow up change controls related to manufacturing (bulk/packaging).
Manage stakeholders involved.Accountable during Health Authorities and Corporate audits/inspections.Apply risk management techniques.Lead risk assessments, data risk assessment and risk management cross functional teams (from draft to approval).Manage and develop the ManufacturingSupport team for all activities in scope (team organization, control, monitoring of the defined targets, Curriculum definition and team training and coaching).Define and set the strategic objectives and provide periodic reporting on overall activities as requested.Communicate pro-actively, consistently and coordinate with the different stakeholders and with the members of the Manufacturing Department to meet plant objectives.Owner of the defect library and the related training for the site.Coordinate improvement or development process linked to the manufacturing area.Lead corrective actions and improvement initiatives within the Manufacturing department.Ensure the KPIs of Support activities are defined and met as per targets.Conform to the directives and instructions defined in the pharmaceutical site quality system.Keep up to date with current industry best practices that may give an operational or strategic advantage to BMS.Define the mid-term strategy for the team with regards to activities/projects and to resource planning (gap-assessment, succession plans).
Commercial site contact for all product/technology transfer activities, including product & process development, scale-up and transfer, commercial control strategy, QbD and PAT and in general in the relationship with MS&T department.
Author and review manufacturing documents, including specifications, working practices, Forms and logbooks.
Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.Act as Backup function for his peers as necessary (Bulk, Packaging, Warehouse).
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