Quality Assurance Senior Manager

Lets do this. Lets change the world. In this vital role you will be serving patients through internal collaboration with Amgens global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgens missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.

The Senior Manager Quality Assurance 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

• Oversee a team of 10 to 14 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 teams performance.
• Develop solutions that are thorough, practical, and consistent with functional objectives.
• Work cross functionally with various Amgen teams and key collaborators 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.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 2 years of experience in quality management systems or a related field OR
• Masters degree with 8 to 10years of experience in quality management systems or a related field OR
• Bachelors degree with 10 to 14 years of experience in quality management systems or a related field OR
• Diploma with 14 to 18 years of experience in quality management systems or a related field.

Preferred Qualifications:

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 key collaborators 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.