Sr Associate Quality Compliance

Role Name: Sr Associate Quality Compliance – Documentation Lead

Department Name: R&D Quality

Role GCF: 4

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

The Controlled Documentation Lead supports end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system.

Roles & Responsibilities:

• Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards.
• Track documentation milestones and follow up with contributors to ensure deadlines are met.
• Provide in-depth technical editing and proofreading support to maintain consistency with approved templates and formatting standards.
• Conduct rigorous Q checks to ensure all documents meet regulatory, procedural, and formatting requirements.
• Maintain and update controlled document templates and ensure consistent application across documents.
• Support audits and inspections through documentation readiness activities.
• Collaborate with cross-functional teams to execute document-related tasks and resolve workflow issues.

Basic Qualifications and Experience:

• Masters Degree in Sciences or related field with 3-5 years exp in Pharmaceutical/Biotechnology/Clinical research

Functional Skills:

Must-Have Skills:

• Strong project management skills including milestone tracking and workflow oversight.
• High proficiency in technical editing and document formatting.
• Familiarity with regulatory documentation in a GCP or similar environment.
• Experience with document management systems and inspection readiness.

Good-to-Have Skills:

• Experience working in a multinational environment with global teams.
• Proven ability to manage multiple documents simultaneously while maintaining high quality.

Soft Skills:

• Excellent verbal and written communication skills.
• Strong problem-solving abilities and adaptability to changing priorities.
• Strong attention to detail and accuracy.
• Excellent organization and coordination skills.
• Clear and concise communication abilities.
• Team-oriented and proactive approach.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.