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Associate Director , External Manufacturing Lead (Remote)

3+ years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, External Manufacturing Lead (Remote)
Company: Jazz Pharmaceuticals
Location: London, City of London, UK – [Remote/Home-Based]
Category: Technical Operations
Req ID: R010161


Brief Description

The Associate Director, External Manufacturing Lead (EML) will oversee the performance of an external Contract Manufacturing Organisation (CMO) portfolio for Jazz’s commercial products. This role involves managing relationships with CMOs, ensuring contract compliance, and leading cross-functional teams to execute manufacturing and supply plans. The EML will be responsible for improving CMO performance, mitigating risks, and driving continuous improvement initiatives to enhance supply chain efficiency while maintaining alignment with Jazz’s Technical Operations strategy.


Essential Functions/Responsibilities

Contract Manufacturing Organisation (CMO) Relationship and Performance Management

  • Build and manage strong business relationships with CMOs, ensuring mutual value creation and a culture of continuous improvement.

  • Oversee CMO performance, ensuring they meet quality, cost, delivery time, and compliance standards.

  • Lead Business Review Meetings (BRMs) and document outputs in alignment with Jazz’s procedures.

  • Proactively manage CMO performance and resolve issues to align with business objectives.

  • Define and implement multiyear performance improvement initiatives with CMOs.

Leadership and Cross-functional Collaboration

  • Lead cross-functional teams, ensuring successful execution of manufacturing and supply plans.

  • Act as the primary point of contact for all performance and supply-related issues, mitigating disruptions.

  • Set objectives for assigned CMOs and align them with broader organizational goals.

  • Manage the selection, onboarding, and performance of CMOs to support Jazz’s Technical Operations strategy.

Planning and Execution

  • Develop and oversee manufacturing and supply plans for Drug Substance, bulk Drug Product, and Finished Product, ensuring timely and on-budget execution.

  • Lead internal and external meetings, drive agendas, and prioritize issues to enhance decision-making.

  • Track and report performance against budget, ensuring cross-functional resources are effectively leveraged.

Risk Management

  • Identify and document supply risks, developing and executing mitigation plans.

  • Communicate and escalate risks to senior management as necessary.

  • Support the generation of business continuity plans for Jazz’s external network.

Innovation and Continuous Improvement

  • Foster a culture of continuous improvement within teams and CMOs to enhance product quality, reduce costs, and improve supply chain efficiency.

  • Share best practices and drive excellence in external manufacturing by collaborating with business partners.

Data Analysis and Reporting

  • Develop and implement best practices and KPIs to enhance CMO performance.

  • Utilize data analytics to monitor supplier performance, identify trends, and present performance reports to senior management.

Supplier Compliance and Contract Management

  • Oversee Master Services Agreements (MSAs) with CMOs, ensuring alignment with business needs.

  • Partner with Quality, Legal, and Procurement teams to ensure compliance with quality and legal agreements.

  • Lead CMO governance to ensure compliance with policies, regulatory requirements, and industry standards.


Qualifications

  • Education: Bachelor’s degree required (Life sciences preferred).

  • Experience:

    • Strong background in managing CMOs within the pharmaceutical/biopharmaceutical industry.

    • Proven track record in supply chain management, supplier relationship management, and performance improvement.

    • Experience in leading cross-functional teams and managing risks.

  • Skills:

    • Expertise in GMP, regulatory compliance, and pharmaceutical manufacturing.

    • Familiarity with supply chain and manufacturing software/tools (e.g., SAP, ERP systems).

    • Ability to use data analytics to monitor performance and drive decision-making.

  • Industry & Functional Experience:

    • Pharmaceutical, Biotech, or Life Sciences industry experience.

    • Experience in External Vendor Management, Manufacturing Operations, and Procurement.

  • Language: Proficiency in English (both written and spoken).


Additional Information

  • Physical Demands: Primarily office-based with some travel requirements.

  • Work Environment: Remote/home-based with occasional travel.

  • Schedule: Flexible, with an emphasis on meeting organizational objectives.


Compensation

  • Benefits: Eligible for medical, dental, and vision insurance, retirement savings plans, and flexible paid vacation.

For more information on benefits, please visit: Jazz Benefits.


Jazz Pharmaceuticals is an equal opportunity employer.