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Qa Manager

6-8 years
Not Disclosed
10 April 9, 2025
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:

QA Manager

Job ID:

R-209217

Location:

India – Hyderabad

Work Location Type:

On Site

Date Posted:

March 4, 2025

Category:

Quality


About the Company:

Amgen is a leading biotechnology company that has been at the forefront of innovation since 1980. With a mission to serve patients suffering from serious illnesses, Amgen focuses on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Through research, manufacturing, and delivery of innovative medicines, Amgen aims to help people live longer, fuller, and healthier lives.


Role Overview:

The QA Manager will be responsible for overseeing quality assurance activities at the Amgen Technology and Innovation Center in Hyderabad. The role involves managing a team of quality professionals and collaborating with internal global teams as well as external contract manufacturing organizations to ensure the production and supply of high-quality products.


Key Responsibilities:

  • Manage a team of approximately six staff, ensuring structured, compliant task execution

  • Ensure team members are trained and qualified per company standards

  • Conduct performance reviews, goal-setting, and compensation planning

  • Implement and maintain quality records in line with GMP and regulatory requirements

  • Identify and drive process improvements using lean principles and automation

  • Track and report quality metrics to senior leadership

  • Collaborate cross-functionally to ensure seamless process transitions

  • Prepare, review, and approve SOPs and GMP/GDP documentation

  • May require shift work or extended hours to accommodate global time zones


Qualifications:

Educational Background (one of the following):

  • Doctorate degree, or

  • Master’s degree with 4–6 years of experience in quality management systems or a related field, or

  • Bachelor’s degree with 6–8 years of experience, or

  • Diploma with 10–12 years of experience

Additional Requirement:

  • Experience managing staff in a GXP environment


Required Skills:

Must-Have:

  • Minimum of 6 years’ experience in a cGMP manufacturing environment

  • Strong foundation in quality assurance practices

  • Proven leadership and team management skills

  • In-depth understanding of regulatory expectations

  • Ability to influence and inspire others

Good-to-Have:

  • Experience in investigations, project management, and data analysis

  • Supplier management, raw materials, packaging, or device manufacturing experience

  • Knowledge of API, drug substance, drug product, packaging, and device manufacturing

  • Process design or improvement at a conceptual level

  • Understanding of robust QMS and documentation standards

Soft Skills:

  • Excellent analytical and problem-solving capabilities

  • Strong written and verbal communication

  • Ability to work in global, virtual teams

  • Self-motivated and organized

  • Strong public speaking and presentation skills

  • Team-oriented mindset


What to Expect from Amgen:

  • Competitive benefits and career development opportunities

  • Collaborative and innovation-driven culture

  • Supportive environment for both professional and personal growth

  • Inclusive workplace committed to advancing science and improving lives


Application:

Apply now at careers.amgen.com for a career that defies imagination.

Amgen is an Equal Opportunity Employer and is committed to providing reasonable accommodations during the recruitment process for individuals with disabilities..