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    Head Pid Governance And Process

    Abbott
    12+ years
    Not Disclosed
    Mumbai
    10 Dec. 30, 2024
    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: Head of Product Ideation and Design (PID) Governance and Process

    Department: Innovation & Development (I&D)
    Location: Not specified
    Job Function: Governance, Process Management, Quality Systems

    Primary Job Function

    The Head of PID Governance and Process oversees the effective and compliant execution of Product Development, Clinical Supplies, Pre-Clinical, and Packaging activities, ensuring alignment with internal and external standards. The role focuses on driving innovation and solutions that address operational excellence needs across global and regional PID activities.

    Core Job Responsibilities

    Governance

    • Self-Assessment and Risk Management: Develop and implement the PID self-assessment plan, including risk assessments and proposing topics for evaluation. Ensure continuous improvement through tracking and reporting activities.
    • Audit Support: Assist PID functions in internal and external audits, and collaborate on internal management reviews to ensure compliance.
    • Collaboration with Quality: Work closely with the Innovation & Development Quality function to ensure alignment with Abbott procedures and industry standards.
    • Continuous Improvement: Champion best practices within the organization and contribute to ongoing process enhancements.
    • Learning & Compliance: Take ownership of continuous learning to stay updated on Abbott policies, regulations, and industry practices impacting procedural standards and quality systems.

    Process

    • Quality System Ownership: Manage and maintain functional Quality System documents related to Product Development, ensuring compliance with Abbott corporate and external standards (ICH GxP and other regulatory requirements).
    • Document Creation and Review: Collaborate with subject matter experts to develop and update functional Quality system documents, ensuring clarity, accuracy, and compliance.
    • Training Oversight: Own the department’s training content and matrix, ensuring personnel are compliant with training plans that align with EPD procedures.
    • Non-Compliance Management: Identify and remediate non-compliance areas in collaboration with quality, compliance, and ethics teams.
    • Operational Training Needs: Identify and address training gaps, delivering relevant content with internal and external subject matter experts.
    • External Stakeholder Management: Oversee relationships with external service providers, ensuring adherence to contractual deliverables.

    Position Accountability / Scope

    • Internal Stakeholders: PID team, Quality Assurance, Regulatory Affairs, Operations, Clinical Development, Office of Ethics & Compliance, I&D Centers.
    • External Stakeholders: Business partners, contractors, consultants, vendors.

    Minimum Education

    • Bachelor of Science in a life sciences-related field or equivalent experience.

    Experience

    • 12+ years in the pharmaceutical industry, with a strong background in Product Development, Pre-clinical, Clinical Supplies, or Packaging.
    • Familiarity with global fast-paced environments, understanding industry regulations, and experience in quality management.
    • Experience in authoring and reviewing procedural documents, with strong written and spoken English communication skills.
    • Proficiency in MS Office (Excel, Word), and experience in records management and quality control systems.

    Key Skills and Attributes

    • Attention to Detail: High standards of accuracy, organization, and multi-tasking.
    • Independent Worker: Ability to apply professional knowledge and experience with minimal guidance.
    • Effective Communication: Ability to engage stakeholders at all levels of the organization.
    • Fluency in English: Essential for communication and documentation.

    This leadership role is crucial for ensuring operational efficiency and compliance across multiple facets of the PID process, with a strong focus on continuous improvement, governance, and stakeholder management within a global pharmaceutical environment.

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