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Sr. Manager- Product Quality

3-5 years
Not Disclosed
10 Dec. 24, 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

Join Lilly: Where Caring Meets Discovery

At Lilly, we unite compassion with innovation to make life better for people worldwide. Headquartered in Indianapolis, Indiana, Lilly is a global healthcare leader. Our employees are committed to discovering and delivering life-changing medicines, advancing the understanding of diseases, and giving back to communities through philanthropy and volunteerism. We put people first and give our best effort in everything we do. We’re looking for individuals who are determined to make a positive impact on the world.


Role: Quality Assurance Manager - Lilly India & Nepal

The Quality Assurance Manager will oversee compliance with Good Distribution Practices (GDP) and relevant regulatory requirements across the Lilly supply chain in the India affiliate and Nepal. This role ensures quality assurance processes are executed smoothly and compliance is maintained throughout the product lifecycle. The position involves collaborating with cross-functional teams and managing key quality-related activities such as audits, complaints, and documentation.


Key Responsibilities

  • Ensure Compliance: Ensure adherence to Good Distribution Practices (GDP) and other applicable regulations across the supply chain.
  • Cross-Functional Collaboration: Work closely with teams such as Regulatory Affairs, Supply Chain, Pharmacovigilance, and affiliate management to ensure smooth operations.
  • Risk Identification & Mitigation: Proactively identify quality risks and implement corrective actions in collaboration with relevant teams.
  • Issue Resolution: Address and resolve quality-related issues swiftly, escalating as needed to minimize operational disruptions and customer impact.
  • Audits & Inspections: Conduct regular audits and warehouse inspections to verify compliance with quality standards and regulatory requirements.
    • Travel Required: Approximately 5-7 working days per month within India.
  • Product Complaints: Provide support in collecting and managing product complaints to ensure accurate handling.
  • Training & Guidance: Deliver training and guidance on quality standards, regulations, and procedures to external parties and internal teams.
  • Documentation & Compliance: Maintain accurate documentation in line with Good Documentation Practices (GDP), ensuring audit readiness at all times.

Requirements

  • Education: Bachelor’s degree in pharmacy or a related life sciences field; Postgraduate degree is a plus.
  • Experience: 3-5 years of experience in Quality Assurance, with experience in regulatory affairs considered an advantage.
  • Travel: Ability to travel frequently (20-30% travel time within India).
  • Auditing Experience: Experience in warehouse auditing is required.
  • Regulatory Knowledge: Strong knowledge of Good Distribution Practices (GDP) and other relevant regulations in India.
  • Communication Skills: Strong verbal and written communication skills, with the ability to present complex information clearly to stakeholders.
  • Organizational Skills: Strong organizational and time-management skills, with the ability to manage multiple priorities effectively.

Additional Information

  • Location: Eli Lilly Gurgaon Office
  • Travel Requirements: Frequent travel (approximately 5-7 working days/month) within India.

Diversity and Inclusion at Lilly

Lilly is dedicated to creating an inclusive and diverse workplace. We ensure equal opportunities for all, including individuals requiring accommodations during the application process. If you need assistance, please complete our Accommodation Request Form.


Lilly is an Equal Opportunity Employer
We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.

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