In this role you will be serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.
The QA Manager will support implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers and contract manufacturers. You will be responsible for leading a team of quality professionals who will be maintaining and approving various quality documents including but not limited to: supplier documentation, analytical results investigations, CAPA and audit records. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams
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:
- Excellent analytical and troubleshooting skills.
- Strong verbal and written communication skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals
- Strong presentation and public speaking skills.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.
