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Sr. Manager- Product Quality

3-5 years
Not Disclosed
10 Jan. 16, 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

Job Title: Quality Assurance Manager
Location: Eli Lilly Gurgaon Office
Travel Required: 20-30% within India

At Lilly, we unite caring with discovery to improve lives around the world. As a global healthcare leader, headquartered in Indianapolis, Indiana, our mission is to bring life-changing medicines to those who need them, improve disease understanding, and give back to our communities through philanthropy and volunteerism. We are seeking individuals who are committed to making life better for people around the world.

Scope of the Position:

The Quality Assurance Manager will oversee the quality assurance of Lilly pharmaceuticals within the Lilly India Affiliate and Nepal, ensuring compliance with industry standards and regulatory requirements.

Responsibilities:

  • Ensure compliance with Good Distribution Practices (GDP) and relevant regulatory requirements across the supply chain.
  • Collaborate with cross-functional teams, including Regulatory Affairs, Supply Chain, Pharmacovigilance, and Affiliate Management.
  • Proactively identify quality risks and work with relevant teams to implement corrective actions.
  • Swiftly resolve any quality-related issues or complaints, escalating as needed, to minimize operational impact and enhance customer satisfaction.
  • Conduct regular audits and inspections of warehouses to ensure quality and compliance standards are met.
  • Travel to various locations within India (5-7 working days per month) for audits and inspections.
  • Support the collection and management of product complaints.
  • Provide training and guidance on quality standards, procedures, and regulations to external parties and internal teams.
  • Maintain accurate documentation in line with Good Documentation Practices and ensure audit readiness at all times.

Requirements:

  • Bachelor’s degree in Pharmacy or a related life sciences field; postgraduate degree preferred.
  • 3-5 years of experience in Quality Assurance; regulatory experience is a plus.
  • Strong knowledge of GDP and India’s regulatory requirements for Quality Assurance.
  • Experience in warehouse auditing.
  • Strong communication skills, both verbal and written, with the ability to effectively communicate complex information to various stakeholders.
  • Excellent organizational and time-management skills with the ability to manage multiple priorities.
  • Position based at the Eli Lilly Gurgaon office, with frequent travel within India (approximately 5-7 working days per month).

Lilly is committed to providing equal employment opportunities and accommodations for individuals with disabilities. If you need assistance in the application process, please complete the accommodation request form on our website.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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