Quality Assurance Senior Manager

Amgen • Columbus, OH

7d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Quality Assurance Senior Manager What you will do Let’s do this. Let’s change the world. In this role of Quality Senior Manager you will be responsible for quality oversight of multiple secondary packaging components external suppliers which provide global goods and services to Amgen. You will be part of a multifunctional team and work within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. You will work closely with External Supply, Process Development, Combination Product Quality, and various other parts of Operations. This role also has regional responsibilities across multiple manufacturing sites. The Quality Senior Manager will report into Associate Director of External Supply Quality for North America. This role can be filled in multiple locations in US, but proximity close to Amgen's advanced packaging facility in Ohio is preferred. Travel may be required.

Requirements

• Doctorate degree and 2 years of Quality and Compliance experience OR Master’s degree and 4 years of Quality and Compliance experience OR Bachelor’s degree and 6 years of Quality and Compliance experience OR Associate’s degree and 10 years of Quality and Compliance experience OR High school diploma / GED and 12 years of Quality and Compliance experience

Nice To Haves

• Educational background in Life Sciences
• Strong technical knowledge and experience within operations in the pharmaceutical or GMP-regulated industry
• Relevant work experience within Drug Product and Finished Drug Product operations
• 5+ years of experience overseeing quality of suppliers
• Robust problem-solving and root-cause analysis experience
• Strong continuous improvement mentality
• Strong compliance, quality, and regulatory knowledge with critical thinking, inquisitive with an end-to-end mentality
• Strong communication skills with proficiency in the English language and collaborative cross-functionally behavior
• Strong report writing and presentation skills
• Experience driving decision-making by using DAI principles
• Understanding of industry requirements/expectations of a QMS
• Savvy with data and Artificial Intelligence tools
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Knowledge of Primary and Secondary packaging is a plus

Responsibilities

• Ensure appropriate quality oversight of suppliers in line with global regulations, defines quality requirements for suppliers and monitors performance
• Monitors and assigns quality status and, if required, determines remediation actions and additional oversight needed, including technical site visits
• Maintains key quality performance indicators for suppliers of responsibility
• Review and approval of quality records such as; Quality Agreements, supplier investigations, deviations, supplier change notifications, change controls, CAPAs, and CAPA-EV’s
• Manage supplier audits to completion
• Act as point of contact for Amgen sites to resolve concerns and support projects regarding secondary packaging materials and suppliers
• Represent Amgen at product-specific regulatory inspections and/or during Notified Body audits of supplier site
• Identify and mitigate risks at supplier site and raise to management as appropriate
• Onboard and offboard suppliers and/or manufacturing location as needed
• Lead departmental improvement projects regarding continuous improvement and automation

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed