Roles & Responsibilities:

Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner.
Ensure team members are appropriately qualified and trained to perform needed activities per company procedures.
Conduct goal setting, performance reviews, and compensation planning to align with organizational goals.
Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and regulatory requirements.
Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation.
Develop, monitor and report metrics to senior management to assess the health of the team's performance.
Develop solutions that are thorough, practical, and consistent with functional objectives.
Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks and continuity across groups.
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), Good Distribution Practices (GDP) and other applicable regulations.
This role may require working in shifts or extended hours within the same shift to support global time zones.

What we expect of you

Basic Qualifications and Experience:

Doctorate degree OR
Master's degree with 4 to 6 years of experience in quality management systems or a related field OR
Bachelor's degree with 6 to 8 years of experience in quality management systems or a related field OR
Diploma with 10 to 12 years of experience in quality management systems or a related field.
Experience managing staff in a GXP environment

Functional Skills:

Must-Have Skills:

Working foundation in quality assurance roles and proven team leader.
Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them

Good-to-Have Skills:

Experience in investigations, project management and trending and analysis
Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
Proven experience in designing and/or improving processes at conceptual level
Desire to partner with internal and external stakeholders across teams
Understanding of industry requirements/expectations of a robust Quality Management System and documentation.

Soft Skills:

Software Trainee

Cambridge Coordinator