Перейти к основному содержимому
BridgeBio

Commercialization Project Manager

УдалённоNetherlands только
Опубликовано
Роль
Управление проектами
Опыт
Лид
Занятость
Полная занятость
Зарплата не указана
Проверьте доступность

Доступно для: NL only. Укажите, откуда вы работаете, чтобы проверить доступность.

Коротко по делу

Project manager based in the Netherlands with 10+ years of Supply Chain/Project Management experience in Life Sciences commercial products. Must know change/variation management in regulated pharma, GMP/GDP, QMS/RIMS, project tools, and have multi-market experience across EU, LACAN, MENA, and APAC. Fluent written and spoken English required.

Ключевые навыки

Change Control ManagementVariation ManagementProject Management

Обязательные навыки

GMPGDPQMSSmartsheetMS Project

Обязательные языки

English Fluent in written and spoken English.

Чем предстоит заниматься

  • Drive successful execution of product commercialization activities within Supply Chain.
  • Act as the primary link between Packaging and Regulatory departments to execute Artwork milestones for timely product launch.
  • Own the Supply Chain Change Control strategy.
  • Support implementation of a Product Variation Management process.
  • Provide flexible project support across the broader Supply Chain portfolio.
  • Initiate, assess, and manage change controls related to commercialization activities.
  • Coordinate cross-functional impact assessments with Quality, Regulatory, Manufacturing, Packaging/Artwork and other teams as required.
  • Track change control progress against timelines and proactively escalate risks and delays.
  • Ensure change controls are documented in compliance with Good Documentation Practices and other GxP requirements.
  • Support creation and continuous improvement of the product Variation Management process.
  • Coordinate post-approval variations related to product changes, including CMC and Labeling.
  • Align with internal stakeholders on approval and implementation windows.
  • Maintain variation trackers and ensure traceability between variations, change controls, manufacturing and artwork updates.
  • Ensure Regulatory approval, Change Control and artwork development timelines are synchronized between departments.
  • Support other commercialization projects as needed, including new product launches, site transfers, packaging changes, and Supply Chain network changes.
  • Develop and maintain Commercial Supply Chain project plans, timelines and risk logs.
  • Facilitate cross-functional project meetings and drive actions to closure.
  • Provide status reporting to Supply Chain Leadership and other stakeholders.
  • Perform other duties as assigned.

Что требуется

  • Bachelor’s degree in a related field, such as Life Sciences, Supply Chain, Logistics, Project Management or Business Administration.
  • Minimum of 10 years of Supply Chain / Project Management experience, including Life Sciences industry experience with commercial products.
  • Demonstrated experience with change and variation management processes in a regulated environment.
  • Experience working across multiple markets/jurisdictions (EU, LACAN, MENA & APAC) is a must.
  • Experience supporting product launches and Life Cycle Management activities.
  • Experience coordinating artwork/labeling processes and understanding of regulatory submission cycles is strongly preferred.
  • Strong and clear understanding of GMP/GDP requirements and pharmaceutical industry best quality practices.
  • Familiarity with quality management systems (QMS) and regulatory information management systems.
  • Proficiency in project management tools, e.g. Smartsheet, MS Project.
  • Fluent in written and spoken English.
  • Strong cross-functional communication and stakeholder management skills.
  • Excellent analytical and problem-solving skills, with strong attention to detail.
  • Strong organizational skills with ability to manage multiple concurrent projects and timelines.
  • Approximately 5% travel anticipated.

Преимущества

  • Market-leading compensation.
  • 401(k) with employer match.
  • Employee Stock Purchase Program (ESPP).
  • Pre-tax commuter benefits for transit and parking.
  • Referral bonus for hired candidates.
  • Subsidized lunch and parking on in-office days.
  • 100% employer-paid medical, dental, and vision premiums for you and your dependents.
  • Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA).
  • Fertility and family-forming benefits.
  • Expanded mental health support, including therapy and coaching resources.
  • Hybrid work model with flexibility.
  • Flexible, take-what-you-need paid time off and company-paid holidays.
  • Comprehensive paid medical and parental leave.
  • Opportunities for skill development and internal mobility.
  • Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, and BetterUp Coaching.
  • Financial rewards, peer-to-peer recognition, and growth opportunities for strong performance.

BridgeBio develops life-changing medicines for patients with unmet needs, focusing on rare disease and biopharma innovation.

BiotechСредняяbridgebio.com/

Что говорят о компании

3.0/ 5

Детали

Способ откликаGreenhouse
Зарплата не указана