Senior Director, Commercial Product Quality External Supply

2 weeks ago

Chaoyang Shi, China BeiGene Full time
Job Summary

BeiGene is seeking a highly experienced Senior Director, Commercial Product Quality External Supply to join our team. As a key member of our Commercial Product Quality team, you will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labeled, stored, and transported in a controlled manner that meets regulatory expectations and applicable Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality standards.

Key Responsibilities
  • Lead and develop a team of Quality professionals to ensure product quality from CMOs.
  • Closely work with Distribution and Regional Quality teams to oversee commercial product on the end-to-end supply chain.
  • Manage quality issues and changes at CMOs.
  • Ensure that quality processes meet Health Authorities' expectations and continuously improve them by timely capturing related regulation changes.
  • Advise and support Quality Agreement content, implementation, and updates.
  • Obtain quality performance information at CMOs and drive continuous improvement.
  • Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required.
  • Work cross-functionally and collaboratively in BeiGene with Manufacturing, Supply Chain, Regulatory CMC, and other Quality teams.
  • Provide quality support on product commercial supply, including timely batch release.
  • Support GCP inspections in IMP manufacturing perspective.
  • Execute product recalls from commercial supply chain when needed.
Requirements
  • Bachelor of Science degree or above in a related scientific discipline/technical field such as Pharmacy, Biology, Chemistry, or Engineering.
  • Minimum 12 years of pharmaceutical or biotechnology industry experience.
  • In-depth GMP experience in a quality and manufacturing function.
  • Prior experience in commercial GMP batch release.
  • In-depth knowledge of Quality principles, concepts, industry practices, and standards.
  • Working knowledge and experience with US, EU, ICH, and/or China GMP regulations as well as international regulations.
  • Excellent interpersonal skills, including communication, negotiations, facilitations.
  • Experience in working in a cross-functional and international environment.
  • Good presentation skills.
  • Ability to work independently.
  • Spoken/Written fluency in English required.
Travel

May travel regionally and intercontinentally estimated up to 30%.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

  • Senior Director, Commercial Product Quality External Supply

    4 weeks ago

    Chaoyang Shi, China BeiGene Full time

    Job SummaryWe are seeking a highly experienced Senior Director, Commercial Product Quality External Supply to join our team at BeiGene. As a key member of our Commercial Product Quality team, you will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labelled, stored, and transported...

  • Senior Director, Commercial Product Quality External Supply

    1 month ago

    Chaoyang Shi, China BeiGene Full time

    Job Summary:The Senior Director, Commercial Product Quality External Supply will be responsible for ensuring the commercial products at Contract Manufacturing Organizations (CMOs) are manufactured, packed, labeled, stored, and transported in a controlled manner that meets regulatory expectations and applicable Good Manufacturing Practice (GMP) and Good...

  • Director, Policy

    1 month ago

    Chaoyang, China Dolby Laboratories Full time

    Join the leader in entertainment innovation and help us design the future. At Dolby, science meets art, and high tech means more than computer code. As a member of the Dolby team, you’ll see and hear the results of your work everywhere, from movie theaters to smartphones. We continue to revolutionize how people create, deliver, and enjoy entertainment...

  • Director of Policy and Business Affairs

    3 weeks ago

    Chaoyang Shi, China Dolby Laboratories Full time

    Director of Policy and Business Affairs, ChinaDolby Laboratories is seeking a seasoned professional to lead our policy and business affairs efforts in China. As Director of Policy and Business Affairs, you will be responsible for developing and implementing strategic relationships with Chinese government authorities, policy-makers, industry/trade...

  • Director of Policy and Business Affairs

    1 week ago

    Chaoyang Shi, China Dolby Laboratories Full time

    Director of Policy and Business AffairsDolby Laboratories is seeking a highly skilled and experienced Director of Policy and Business Affairs to join our team in Beijing, China. As a key member of our Asia-Pacific government relations team, you will be responsible for developing and implementing strategic relationships with Chinese government authorities,...

  • Director, Policy and Business Affairs

    1 month ago

    Chaoyang Shi, China Dolby Laboratories Full time

    Job SummaryDolby Laboratories is seeking a highly experienced and skilled Director, Policy and Business Affairs to join our team in Beijing, China. As a key member of our Asia-Pacific government relations team, you will be responsible for developing and implementing strategic relationships with Chinese government authorities, policy-makers, industry/trade...

  • Director, GPLM

    6 months ago

    Dongguan Shi, China HARMAN International Full time

    A Career at HARMAN As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA. When you add that to the challenges we take on and solve together, you’ll discover that at HARMAN you can grow, make a difference and be proud of the...

  • Director of Policy and Business Affairs

    4 weeks ago

    Chaoyang Shi, China Dolby Laboratories Full time

    Director of Policy and Business Affairs, ChinaDolby Laboratories is seeking a seasoned professional to lead our policy and business affairs efforts in China. As Director of Policy and Business Affairs, you will be responsible for building and maintaining strategic relationships with Chinese government authorities, policy-makers, industry/trade associations,...

  • Assistant Director of Housekeeping

    5 months ago

    Dongguan Shi, China Four Seasons Hotels and Resorts Full time

    About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to be treated in return. Our team members around the world create amazing experiences for our guests, residents, and partners through a commitment to luxury with...

  • Policy Director

    4 weeks ago

    Chaoyang Shi, China Dolby Laboratories Full time

    Director of Policy & Business Affairs, ChinaDolby Laboratories is seeking a seasoned professional to lead our policy and business affairs efforts in China. As a key member of our Asia-Pacific team, you will be responsible for building and maintaining strategic relationships with Chinese government authorities, policy-makers, industry/trade associations, and...

  • Senior Legal Counsel, China

    1 month ago

    Chaoyang Shi, China Principal Financial Group Full time

    Job SummaryThe Principal Financial Group is seeking a highly skilled and experienced Senior Legal Counsel to join our team in China. As a key member of our legal department, you will provide sound and timely legal advice and services to the company, ensuring corporate affairs are conducted within the framework of applicable laws and regulations, internal...

  • Director, China Clinical Development Lead

    2 months ago

    Shanghai Shi, China Teva Pharmaceuticals Full time

    Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...

  • Product Manager

    5 months ago

    Chaoyang, China Novogene Full time

    Location: China Work place:TianjinResponsibilities: Manages AMEA margin and pricing for products.Plan product strategic development direction and formulate long-term competitive strategy for products. Plan the annual product development direction and formulate the annual product plan.Collaborate with Marketing Manager on Intelligence, and marketing trends to...

  • Global Business Director, Home

    5 months ago

    Guangzhou Shi, China CSA Group Full time

    Employment Status: Regular Time Type: Full time BUILDING A WORLD CLASS TEAM STARTS WITH YOU At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500...

  • Commercial IT Manager

    1 month ago

    Shanghai Shi, China Teva Pharmaceuticals Full time

    Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...

  • Global Business Director, Home

    5 months ago

    Guangzhou Shi, China CSA Group Full time

    Statut d'emploi: Permanent Type d'heures: À temps plein Nous avons besoin de vous pour former une équipe de calibre mondial Les activités du Groupe CSA reposent sur l’atteinte d’un idéal : rendre le monde meilleur, plus sûr et plus durable.Cet ideal est au coeur de notre mission depuis 1919, année où nous avons élaboré notre première...

  • Sales Director, Greater China

    5 months ago

    Guangzhou Shi, China BSI Full time

    Great that you're thinking about a career with BSI! Overview / Purpose of the position We are looking for a Sales Director to provide Commercial Leadership and Sales Excellence to the sales team for the BSI Assurance business focusing on Greater China cluster (Mainland China and Hong Kong). To ensure strategic sales growth in the region and increase...

  • Director of Engineering

    4 months ago

    Shenyang Shi, China Hyatt Corporation Full time

    Director of Engineering - Andaz Nanjing Andaz Andaz Nanjing Hexi CN - 32 - NanjingEngineering/Facility MaintenanceDirectorFull-timeReq ID: NAN000111Local Summary You will be responsible for the efficient running of the division in line with Hyatt Hotels Corporation's Corporate Strategic Priorities, whilst meeting employee, guest and owner...

  • Senior Specialist Social Marketing China

    3 days ago

    Chaoyang, China Dolby Laboratories Full time

    Dolby Overview: Join the leader in entertainment innovation and help us design the future. At Dolby, science meets art, and high tech means more than computer code. As a member of the Dolby team, you’ll see and hear the results of your work everywhere, from movie theaters to smartphones. We continue to revolutionize how people create, deliver, and...

  • Senior Enterprise Sales Executive

    1 month ago

    Chaoyang Shi, China Infoblox Full time

    Position Overview At Infoblox, we are at the forefront of cloud-first networking and security solutions. Recognized as a Top 25 Cyber Security Company, we empower organizations to leverage the cloud for seamless, scalable, and reliable network experiences. Our clientele includes a significant portion of the Fortune 500, and our achievements are driven by...