Manager QA

What you will do

Role Description:

In this role, you will serve patients through internal collaboration with Amgens global quality teams, manufacturing sites, commercial supply chains, Amgen affiliates, warehouses, and external logistic partners in various regions and countries. You will contribute to ensuring high-quality and right-first-time quality systems activities at Amgen, build and support a resilient supply network, and conclude with a positive patient experience.

The Manager of Quality Assurance will support the implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, as well as will be responsible for leading a team of quality professionals who will maintain and approve various quality documents, including but not limited to Quality documentation and metrics, validation documentation, investigations, CAPA and audit records, and quality agreements. This role will involve collaboration with various Amgen teams 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, structured manner.
• Ensure team members are appropriately qualified and trained to perform quality activities per company procedures.
• Conduct goal setting, performance reviews, and compensation planning
• Develop, implement, and maintain the quality records in compliance with industry standards and regulatory requirements.
• Continuously improve documentation processes to enhance efficiency and quality by applying lean principles and automation
• Conduct internal audits and coordinate external audits to ensure quality compliance.
• Analyze data and metrics to identify trends and areas for improvement within the quality systems.
• Work cross-functionally and cross-regionally with various Amgen teams and stakeholders to ensure seamless task transitions 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.
• Provide support for domestic and foreign regulatory agency site inspections.
• What we expect of you
• We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications and Experience:

• Doctorate degree OR
• Masters degree with 2 to 4 years of experience in quality management systems or a related field OR
• Bachelors degree with 4 to 6 years of experience in quality management systems or a related field OR
• Diploma with 8 to 10 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.