Senior Manager QA, International Affiliates

What you will do

Role Description:

In this role, you will serve patients through internal collaboration with Amgens global quality teams and manufacturing sites and external engagement with suppliers of raw materials and devices. You will make key contributions to ensure high quality and right-first-time materials are received at Amgen, build a resilient supply network, and conclude with a positive patient experience.

The Senior Manager of Quality Assurance will support the implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers, distributors, and logistics. Service providers, transport service providers, warehouses, 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 and metrics, validation documentation, investigations, CAPA and audit records, and quality agreements. This role will involve collaboration with various Amgen teams at multiple regions and local affiliates to ensure seamless handoffs between teams

Roles & Responsibilities:

• Oversee a group of 5 to 10 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 established 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 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.
• What we expect of you

Basic Qualifications and Experience:

• Doctorate degree OR
• Masters degree with 6 to 8 years of experience in quality management systems or a related field OR
• Bachelors degree with 8 to 10 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.

Must-Have Skills:

• Working foundation in quality assurance roles and proven team leader.
• Minimum of 2 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.