Quality Compliance Manager

12-14 years

Not Disclosed

Hyderabad

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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 Compliance Manager

Location: Amgen (Multiple Locations)
Company: Amgen

About Amgen:

Amgen has been a leader in biotechnology since 1980, with a mission to serve patients living with serious illnesses. With expertise in Oncology, Inflammation, General Medicine, and Rare Diseases, Amgen touches the lives of millions of patients annually. Our award-winning culture is driven by collaboration, innovation, and a science-based approach to advancing the treatment of the world’s toughest diseases.

Join us and make a lasting impact on patients’ lives while developing your career in one of the most dynamic industries in the world.

Role Overview:

As a Quality Compliance Manager, you will play a key role in supporting Amgen’s Good Clinical, Laboratory, and Manufacturing Practices (GxP) Intelligence operations. The focus will be on project management related to GMP/GDP/CMC/QMS. You will be part of a global network, providing valuable insights to Amgen’s internal teams and supporting external initiatives that influence operations worldwide.

Key Responsibilities:

Project Management & Operational Excellence:
- Lead and manage projects that support GxP Intelligence, focusing on operations related to GMP, GDP, CMC, and QMS.
- Gain internal and external knowledge of trends, early signals, and evolving issues affecting global operations.
- Set up, improve, and manage related databases and quality systems to ensure efficient operations.
Data Analysis & Reporting:
- Conduct assessments and analyze data to communicate findings and developments to key stakeholders.
- Share important information with internal teams and contribute to the alignment of global strategies.
Cross-functional Collaboration:
- Work closely with various functions, including R&D Policy, Governmental Affairs, supply chain, manufacturing, and development sites.
- Network across Amgen teams to promote collaboration and ensure effective execution of quality systems.
Continuous Improvement:
- Identify and undertake additional projects with a focus on continuous improvement and development opportunities.
- Provide support and backup for other quality roles as necessary, ensuring consistent high standards of work.

What We Expect of You:

We seek an individual who will bring their unique contributions to our mission of serving patients. The ideal candidate will possess the following qualifications:

Basic Qualifications:

Doctorate Degree and 1 year of relevant experience, OR
Master’s Degree and 6-8 years of relevant experience, OR
Bachelor’s Degree and 8-10 years of relevant experience, OR
Diploma and 12-14 years of relevant experience.

Key Skills:

Communication: Excellent communication skills, both written and verbal.
Project Management: Strong background in managing complex projects.
Conflict Resolution: Ability to resolve conflicts effectively.
Team Building & Networking: Proven experience in building networks and working collaboratively across functions.
Organization & Planning: Ability to plan, prioritize, and manage time effectively with attention to detail.

What You Can Expect From Us:

At Amgen, we prioritize the professional and personal growth of our employees. We provide a comprehensive and competitive benefits package and a collaborative environment that fosters innovation. As part of our team, you will have the opportunity to contribute to groundbreaking treatments and work alongside passionate colleagues who share a common mission to serve patients.

How to Apply:

Interested candidates are encouraged to apply through Amgen’s career portal:
careers.amgen.com

Amgen is an Equal Opportunity Employer:
Amgen embraces diversity and strives to provide an inclusive work environment. All qualified applicants will be considered for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations will be provided to individuals with disabilities as needed.

Transform the lives of patients, and your career, with Amgen!

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Quality Compliance Manager

Job Description

Job Title: Quality Compliance Manager

About Amgen:

Role Overview:

Key Responsibilities:

What We Expect of You:

Basic Qualifications:

Key Skills:

What You Can Expect From Us:

How to Apply:

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