Associate Director, Distribution Quality

vor 7 Monaten

Basel, Schweiz BeiGene Vollzeit

General Description:_

The position will report to the Senior Director, Distribution Quality, will provide GDP/GSP expertise and manage day to day operations for distribution of IMPs and commercial products globally for BeiGene. The incumbent will ensure that clinical and commercial products are supplied to these markets in accordance with regulatory expectations and applicable quality standards.

Essential Functions of the job:

- Develop and implement QMS for the distribution of pharmaceutical products, ensuring adherence to GDP/GSP requirements and other regulatory requirements and industry best practices.
- Manage distribution quality related activities, including cold chain, lane risk assessment, shipping validation, change control, deviations investigation, temperature excursion within the distribution network providing timely resolution and escalation as needed.
- Manage and oversight the distributors, LSPs and TSPs. Conduct Due Diligence as needed.
- Support HA inspections and internal audits.
- Establish and monitor of key performance metrics of distribution process.
- Work with commercial business team and other quality functions to support the product launch and market expansion.
- Cultivate productive and collaborative relationships, across functional areas and geographies, including Commercial, Supply Chain, External Supply Quality, Internal Supply Quality and Regional Quality teams, to maintain robust quality systems throughout the distribution process to the market.

Experience:

- Min 7 years pharmaceutical or biotechnology industry experience.
- Extensive GDP and GSP experience in a quality function.
- Extensive cold chain experience
- Worked in commercial environment, technical development and clinical environment experience is an asset as well as regional experience in EU.

Core Knowledge and Skill Requirements:

- In-depth knowledge of GDPs.
- In-depth knowledge of Quality principles, concepts, industry practices and standards.
- Working Knowledge and experience with regional pharmaceutical regulations and experience in working with regional Health Authorities like FDA, EMA and others.
- Good verbal, written and interpersonal communication skills.
- Ability to work independently with scientific/technical personnel.
- Experience with regulatory compliance inspections.
- Must possess strong presentation skills to speak effectively before groups; ability to respond.
- Good interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.

Computer Skills:

- PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)
- Veeva Vault Quality Docs; Veeva Vault Quality Suite; Veeva Submissions; SAP
- UL ComplianceWire; UL LearnShare

Travel:

- May travel approximately 25 %

Ability to work on a computer for extended periods of time

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

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

  • Associate Director Quality Assurance and Compliance

    vor 2 Monaten

    Basel, Schweiz Veristat Vollzeit

    Job Description: Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) - Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance...

  • Associate Director Quality Assurance and compliance

    vor 1 Monat

    Basel, Schweiz Veristat Vollzeit

    Job Description:Associate Director Quality Assurance and ComplianceThe Associate Director, Quality Assurance and Compliance (QAC) – Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands-on administration and management of Quality Systems and ensures compliance...

  • Associate Director Quality Assurance and compliance

    vor 4 Wochen

    Basel, Schweiz ““Veristat, Inc. Vollzeit

    Associate Director Quality Assurance and ComplianceThe Associate Director, Quality Assurance and Compliance (QAC) – Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities. This role provides hands-on administration and management of Quality Systems and ensures compliance with Good...

  • Associate Director Quality Assurance and compliance

    vor 2 Monaten

    Basel, Schweiz Veristat Vollzeit

    Job Description : Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) – Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures...

  • Associate Director, Product Quality Lead, Quality

    vor 4 Monaten

    Basel, Schweiz Moderna Vollzeit

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...

  • Associate Director, Global Logistics

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: The Associate Director of Global Logistics Project Resilience is a newly created position responsible to lead the Global Logistics Workstream in Moderna’s Resilience project to establish 3 manufacturing sites in Australia, Canada and UK. He/She must ensure that the logistics set-up is an accurate reflection of the business requirements and in...

  • Business Analytics Associate Director

    vor 6 Monaten

    Basel, Schweiz Novartis Vollzeit

    390892BR **Business Analytics Associate Director**: Switzerland **About the role** Location: Basel, Switzerland (Hybrid) **About this role**: Our **Business Analytics Associate Director** manages metrics for 400+ trials, provides analytics as a service, and advance automation and data science tools to enable data driven decision making to reduce clinical...

  • Associate Director Strategy

    vor 1 Monat

    Basel, Schweiz Abbott Laboratories Vollzeit

    **Abbott **is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Associate Director Rwe

    vor 1 Monat

    Basel, Schweiz Datalynx AG Vollzeit

    For our client, a well-known pharmaceutical company in Basel, we are looking for an Associate Director RWE (M/F/d). **Background** We are looking for an experienced Associate Director RWE & Innovative Evidence to join our team. You will play a crucial role in developing, supporting, and implementing evidence strategies that inform business decisions and...

  • Associate Director Strategy

    vor 1 Monat

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Abbott...

  • Associate Director Strategy

    vor 1 Woche

    Basel, Schweiz Abbott AG Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Abbott...

  • Director Digital Quality

    vor 7 Monaten

    Basel, Schweiz Panda International Vollzeit

    **Director Digital Quality**: **Location** - Basel, Switzerland **Business Sector** - Biotechnology **Job ref** - 22276 **Published** - about 5 hours ago **Director Digital Quality** Are you a professional with expertise in digital quality management within the Pharmaceutical and Biotechnology manufacturing industry? Join a top-tier organization in...

  • Associate Director Strategy

    vor 1 Monat

    Basel, Schweiz Abbott Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott...

  • Associate Director, R&d Quality Systems, Strategy

    vor 2 Monaten

    Basel, Schweiz BeiGene Vollzeit

    General Description: The Associate Director of R&D Quality Systems, Strategy, and Excellence (International & Affiliate) plays a pivotal role in ensuring the consistent implementation and alignment of global quality policies, procedures, and GxP standards at the local and regional levels. This global position is responsible for supporting local affiliates...

  • Associate Director Strategy

    vor 4 Wochen

    Basel, Schweiz Abbott Vollzeit

    JOB DESCRIPTION:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Associate Director Business Development

    vor 2 Monaten

    Basel, Schweiz TFS HealthScience Vollzeit

    Are you passionate about building strong client relationships and identifying business opportunities? Do you thrive in dynamic environments and enjoy working closely with clients to deliver customized solutions? TFS HealthSciences, a leading Contract Research Organization (CRO), invites you to join as an **Associate Director of Business Development** for...

  • Associate Director Global Program Mgnt

    vor 6 Monaten

    Basel, Schweiz Novartis Vollzeit

    391607BR **Associate Director Global Program Mgnt**: Switzerland **About the role** The key accountabilities for the Associate Director, Global Program Management, Oncology are as follows: - Lead project teams with respect to the timing, scenario/options development, risk management, opportunities / challenges, and requirements of interfacing with...

  • Associate Director Business Development

    vor 2 Wochen

    Basel, Schweiz TFS HealthScience Vollzeit

    Are you passionate about building strong client relationships and identifying business opportunities? Do you thrive in dynamic environments and enjoy working closely with clients to deliver customized solutions? TFS HealthSciences, a leading Contract Research Organization (CRO), invites you to join as an Associate Director of Business Development for...

  • Associate Director Business Development

    vor 1 Monat

    Basel, Schweiz TFS HealthScience Vollzeit

    Are you passionate about building strong client relationships and identifying business opportunities? Do you thrive in dynamic environments and enjoy working closely with clients to deliver customized solutions? TFS HealthSciences, a leading Contract Research Organization (CRO), invites you to join as an Associate Director of Business Development for...

  • Associate Director, Accounting

    vor 6 Monaten

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    For our client, an International Pharmaceutical company located in the Basel area, Switzerland, we are looking for a **Associate Director, Accounting & Consolidation** The Associate Director Accounting & Consolidation performs the **consolidation **and is **responsible for supporting quarterly reporting**. The position holder supports **bookkeeping and...