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Global Head Investigational Medicinal Products Quality

0-2 years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Global Head, Investigational Medicinal Products Quality
Location: Basel, Mannheim, Penzberg, or South San Francisco
Category: Quality
Job Id: 202502-102879


Position Overview:

As the Global Head of Investigational Medicinal Products (IMP) Quality, you will be responsible for setting the strategic direction and driving the effective delivery of Roche’s investigational medicines, ensuring compliance with regulatory and quality standards throughout early to late-stage clinical trials. This leadership role will have a global impact and will shape the way Roche delivers high-quality IMP products that meet the needs of patients worldwide.

Key Responsibilities:

  • Strategic Leadership & Collaboration:

    • Oversee the IMP value chain of product, process, and operations.
    • Develop and implement phase-appropriate strategies for IMP products to ensure they meet Health Authority expectations globally.
    • Collaborate with global leaders across Pharma Technical Operations Quality (PTQ), Pharma Cell & Gene Therapy (PTC), Pharma Technical Development (PTD), and other internal functions to advance the IMP portfolio.
  • Strategic Partnerships & Decision Making:

    • Strengthen partnerships with Roche Early Research and Development (gRED/pRED), Global Product Strategy (GPS), Partnering, and Pharma Tech Operations (PT).
    • Engage in executive decisions related to corporate partnerships, deals, and asset acquisitions, ensuring high standards in operational and product quality.
  • Team Leadership:

    • Lead a diverse global team based in multiple locations (South San Francisco, Penzberg, Kaiseraugst, and Basel).
    • Inspire and motivate teams, emphasizing Lean Leadership principles, and ensuring excellence in performance, collaboration, and business outcomes.
  • Digital Transformation & Quality Systems:

    • Support the evolution of digital transformation efforts, including the introduction of new quality systems and innovative technologies.

Qualifications & Requirements:

  • Education:

    • B.S/M.S. degree in Science, Drug Development, Chemical Engineering, or a related field. A Ph.D. is an advantage.
  • Experience:

    • Extensive experience in the pharma/biopharma industry, with in-depth understanding of technical development, FDA, EMA, ICH guidelines, and cGMP requirements.
    • Proven track record of leadership in Quality and Compliance.
    • Demonstrated success leading teams in multicultural organizations, managing financials, and driving business processes.
    • Experience in Quality Operations, Release/Lot-disposition responsibilities, and holding roles like Qualified Person (QP) or Responsible Person (RP) is an advantage.
  • Skills:

    • Strong leadership abilities with an emphasis on building and developing high-performing, global teams.
    • Excellent communication skills to convey decisions and information effectively, including in challenging situations.
  • Travel:

    • Willingness to travel up to 50% of the time.

Why Roche?

At Roche, you’ll work alongside over 100,000 people worldwide, striving to improve healthcare and deliver life-changing medicines. We believe in fostering an inclusive, diverse environment where innovation, curiosity, and diversity are at the heart of everything we do.