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Qa Team Head - (Genome Valley)

3-5 years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Full Time 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

Summary

The Quality Assurance (QA) Lead is responsible for leading a team of quality professionals at TRD GV sites, managing resources, and overseeing capacities. The role involves supervising, guiding, and supporting global TRD project teams in all quality-related aspects while ensuring alignment with organizational objectives and regulatory standards. The QA Lead plays a critical role in developing project strategies and ensuring the quality of deliverables.


About the Role

Major Accountabilities

  • Leadership & Management

    • Lead and manage the team, budget, and resources in line with organizational objectives.
    • Manage global TRD project teams and represent TRD QA in global quality board meetings and project development gate meetings.
    • Guide, mentor, and support functional experts within the QA team.
    • Participate in the recruitment process for hiring quality professionals.
  • Quality Oversight & Compliance

    • Ensure quality oversight on assigned development projects with strong quality guidance, scientific, and technical expertise.
    • Contribute to project strategy, contingency planning, and risk assessment to ensure timely achievement of quality deliverables.
    • Ensure compliance with cGMP guidelines and internal procedures in all project strategies.
    • Provide support for Health Authority inspections, particularly FDA and EMA.
  • Strategic & Cross-Functional Collaboration

    • Manage interactions between TRD QA and other departments inside or outside TRD.
    • Represent TRD QA in due diligence teams, providing quality assessments for potential in-licensing products.
    • Provide input to contracts and QA agreements with third parties, approving project-specific QA agreement amendments.
    • Lead or participate in global and cross-functional quality initiatives.
  • Manufacturing & Regulatory Readiness

    • Ensure alignment with regulatory requirements for health authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
    • Prepare and guide TRD project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission.

Minimum Requirements

Education & Experience

  • Master’s degree in a relevant field with 15+ years of experience in pharmaceutical quality or operations.
  • 3-5 years of experience in people management.
  • Broad understanding of quality standards and policies in Drug Substance, Drug Product, and Medical Devices manufacturing and control.
  • Experience in technical drug development, quality assurance, and/or quality control departments.
  • Experience with Technical Operations or equivalent experience in an external company.

Key Skills & Competencies

  1. Third-Party Management – Strong expertise in managing third-party collaborations.
  2. Manufacturing & Analytical Operations – Hands-on experience in pharmaceutical manufacturing and analytical processes.
  3. Data & Digital Technologies – Familiarity with digital transformation in quality assurance.
  4. People Management – Advanced leadership and mentoring skills.
  5. Stakeholder Management & Communication – Strong ability to influence, negotiate, and communicate with internal and external stakeholders.
  6. Agility & Flexibility – Ability to adapt to changing environments and business needs.
  7. Regulatory Expertise – Knowledge of cGMP guidelines and regulatory requirements for global health authorities.
  8. Project & Risk Management – Ability to proactively identify risks and develop contingency plans.
  9. Technical Proficiency – Computer literacy (e.g., MS Office, document management systems) and readiness to learn new systems.

Why Novartis?

At Novartis, we are committed to reimagining medicine to improve and extend lives. Our vision is to be the most valued and trusted medicines company in the world. Achieving this goal requires passionate, innovative, and collaborative individuals like you.

🔗 Learn more about our culture and mission: Novartis Strategy & People

What You’ll Receive

Novartis offers competitive benefits and rewards to support your personal and professional growth.

🔗 Explore benefits & rewards: Novartis Life Handbook


Commitment to Diversity & Inclusion

Novartis is dedicated to fostering an inclusive and diverse workplace that represents the patients and communities we serve.

Accessibility & Accommodation

If you require a reasonable accommodation due to a medical condition or disability during the recruitment process or to perform job functions, please contact:
📧 Email: diversityandincl.india@novartis.com
📝 Include: Job requisition number and contact details.


Join Our Novartis Network

If this role doesn’t match your experience or career goals but you’d like to stay updated on future opportunities, join our talent network.

🔗 Sign up here: Novartis Talent Community


Job Details

Category Details
Division Development
Business Unit Innovative Medicines
Location India
Site Hyderabad (Office)
Company Novartis Healthcare Private Limited
Functional Area Quality
Job Type Full-time
Employment Type Regular
Shift Work No