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Head Of Quality Strategy Post-Marketing (All Genders)

10+ years
Not Disclosed
10 Dec. 27, 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 Quality Strategy Post-Marketing

Location: [Location]
Department: Healthcare R&D


About Us:

At [Company Name], we're driven by a commitment to innovation and care. We’re working globally across healthcare, life sciences, and electronics to enhance the lives of people and create better solutions for the future. Our diverse, passionate teams are united in developing groundbreaking medicines, technologies, and intelligent devices that improve lives across the globe. Together, we push boundaries, spark creativity, and deliver impactful solutions for our customers, patients, and the planet.


Your Role:

As Head of Quality Strategy Post-Marketing, you will lead the development and execution of a global risk-based strategy for post-marketing processes. You will ensure proactive quality oversight, compliance with industry standards, and regulatory requirements across key areas such as Pharmacovigilance (PV), Medical Affairs, Regulatory Affairs, and Subsidiaries.

Your responsibilities will include:

  • Strategic Oversight: Develop and drive a global risk-based strategy for post-marketing quality oversight, aligning with international and local health authority regulations.
  • Monitor and Assess Quality: Use KPIs, metrics, and data analytics to monitor post-marketing processes, identifying signals, trends, and risks to ensure compliance and quality.
  • Cross-Functional Leadership: Provide strategic direction for due diligence projects and lead continuous improvement initiatives based on audits, inspections, and root cause analyses.
  • Collaboration and Communication: Work closely with executive management and cross-functional teams to resolve compliance risks and communicate critical quality issues effectively.
  • Regulatory and Governance: Provide expert guidance on GxP regulations and ensure alignment with Medical, Regulatory, and Pharmacovigilance strategies across regions.
  • Inspection Readiness: Oversee and drive inspection readiness activities to ensure adherence to industry standards, minimizing risks during audits or inspections.
  • Risk Management: Utilize risk management tools and techniques to evaluate and address risks, ensuring mitigation strategies are in place to prevent issues.

Who You Are:

  • Educational Background:

    • Advanced degree in a relevant scientific discipline (e.g., pharmacy, medicine, life sciences).
  • Professional Experience:

    • Minimum of 10 years of experience in Quality Assurance (QA), medical quality management, biomedical science, clinical development, or regulatory compliance.
    • Proven success in senior management roles with strong accountability and leadership capabilities.
    • Extensive experience in working autonomously within a matrix model and team environment, driving key initiatives and improvements.
  • Key Skills & Knowledge:

    • Deep knowledge of ICH GCP, GPV principles, and overall Quality Assurance practices.
    • Strong leadership in global, cross-functional environments with the ability to influence key stakeholders.
    • In-depth understanding of applied risk management, including risk assessment, evaluation, and communication.
    • Exceptional interpersonal, communication, negotiation, and problem-solving skills.
    • Expertise in driving continuous improvement in complex environments.

What We Offer:

At [Company Name], we celebrate diversity in all its forms. Our inclusive culture values innovation, collaboration, and creativity, providing opportunities for professional growth at every stage of your career. As part of our team, you’ll be empowered to work your magic and make a meaningful impact on human progress.


Apply now and become part of our diverse team!
Join us in shaping the future of healthcare and delivering innovative solutions that improve lives worldwide.