Sr Assoc QA - Global Supply Quality

Amgen Technology; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amgen, a leader in biotechnology, seeks a Sr. Associate QA to oversee quality across alliance partnerships and external supply. You will work within cross-functional teams to ensure GMP/GDP compliance and drive supplier quality initiatives.

Responsibilities include QA contact with partners, change control support, audits, and documentation per Quality Agreements, with emphasis on continuous improvement and cross-organizational collaboration.

Qualifications

• Bachelor's degree in science or engineering with 2+ years' experience.
• Understanding of GMP/GDP requirements.
• Familiarity with raw material testing.
• Experience overseeing supplier quality.
• Strong technical writing and alliance management skills.

Responsibilities

• QA contact role with partners to ensure quality agreements.
• Perform partner assessments for Change Control and Deviations.
• Support audits and documentation per Quality Agreements.
• Collaborate with external suppliers and partners.
• Ensure GMP/GDP compliance across supply lifecycle.
• Prepare, review and approve SOPs and GMP/GDP docs.
• Own business metrics related to supplier relationships.
• Work with cross-functional teams under Amgen leadership.

Skills

QA oversight

GMP/GDP

Alliance management

Quality documentation

Risk management

Process improvement

SOPs

Audits

Education

Bachelor's degree in science or engineering

Tools

Microsoft Office

Job description

Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives.

We are seeking a highly motivated individual for our Global Supply Quality (GSQ) team. This is an incredibly exciting opportunity to join a team of quality professionals.

HOW MIGHT YOU DEFY IMAGINATION

Youve earned your degree. How will you use that achievement to reach your goalsDo more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Live

What you will do

The Sr. Associate QA position is responsible for the Quality oversight of Amgens alliance partnerships and external supply portfolio management. This position is responsible for being an integral quality member of the Amgen cross-functional External Supply and Business Development teams that includes but is not limited to Amgen Contract Development Manufacturing, Process Development, Supply Chain, and Business Development.

Responsibilities

• Perform QA Contact rolefor partners to ensure adherence to quality agreements, identifying performance improvement opportunities
• Perform Partner/Client assessments for Change Control and Deviation records
• Perform Quality tasks in support of Partnership Alliance Quality in accordance with Quality Agreements (i.e. document revisions, document redactions, support partner audits)
• May perform QA responsibilities associated with Portfolio Strategy Execution, such as supporting Due Diligence activities
• Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP.
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP)and other applicable regulations
• Collaborate with external suppliers and partners
• Understand and incorporate risk management strategy into the overall external supply lifecycle
• Supportin tactical activities related to internal/external audits and inspections
• Take part in operational improvement initiatives, programs, and projects
• Develop solutions that are thorough, practical, and consistent with functional objectives
• Ownership of business metrics, performance assessments, and other key documents to inform the health of external supplier and partner relationships.
• Work under minimal supervision in line with Amgen Values and Leadership Attributes.

Win

What we expect of you:

Education and Experiences:

• We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:
• Bachelors degree in science or engineering and 2+ years of professional experience in related fields.
• Understanding of GMP/GDP requirements.
• Familiarity with raw material compendial testing
• Experience overseeing quality of suppliers or external parties
• Strong technical writing skills.
• Strong experience in Alliance Management

Preferred Qualifications

• Strong continuous improvement mindset and lean practices experience.
• Understanding of end-to-end supply chain business processes.
• Experience in project management across multiple departments and geographies.
• Quick process understanding, insight and visualizing.
• Strong analytical and problem-solving skills.
• Independent self-starter, able to work autonomously, under pressure and in teams.
• GMP/GDP knowledge and understanding of pharmaceutical regulations.
• Energetic, detail oriented, highly motivated with a can do outlook.
• Change management skills.
• Ability to communicate across all levels of the organization.
• Effective written and verbal communication skills.
• Experience with Microsoft Office Tools including Excel, Word, and PowerPoint.
• Ability to multi-task and prioritize