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Job Description

Manager, Plant Quality

New Albany, OH

IMPORTANT: This role requires local presence at the New Albany site near Columbus, Ohio.

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Does the thought of building an entirely new site, from the ground up excite you? Do you love building and developing high performing teams? If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the facility will not only feature the best in-class assembly and packaging technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027.

Manager, Plant Quality: New Albany, Ohio

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be managing the Plant Quality Assurance (PQA) team, responsible to oversee the assembly and packaging operations. A key aspect of this role is to apply sophisticated thinking to ensure quality and compliance to GMP regulations for all assembly and packaging operations.

The Manager PQA will play a key role in the Quality Assurance team, focused on building a strong PQA team and establishing efficient Plant Quality processes. The PQA team oversees quality of manufacturing operations (assembly and packaging) and is responsible for batch disposition of the produced Finished Drug Product at the site. Your team will work closely with the manufacturing team to assure product is produced according quality standards and in alignment with the regulatory filing. The team assures the Finished Drug Product is dispositioned in a timely manner to supply every patient every time.

You will support all activities for the set-up of the new assembly and packaging area, working closely with manufacturing to define production processes using a risk-based approach and qualify equipment. You will build and supervise an impactful PQA team supporting manufacturing in a non-standard shift structure that may include second, third and/or weekend as a normal schedule. You will implement the Amgen Quality Management system (QMS) within the PQA area (e.g., Standard Operating Procedures (SOPs) creation, deviation management, change control, CAPA etc.).

• Own the realization of operational activities for PQA while providing technical expertise/guidance to the staff and ensuring Finished Drug Product is dispositioned in a timely manner; handle daily operations in relation to planning and management of the team and their tasks.

• Responsible for selection, training, evaluation, staff relations and development of staff. Interacts with management in optimizing organizational structure and responsibilities.

• Provide oversight of the QMS process implementation applied in manufacturing, including deviation management, CAPAs, work-orders and change controls.

• Interact with Manufacturing, Process Development and other stakeholders for escalated cases of deviations related to process, equipment or materials.

• Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.

• Own and review related SOPs, methods, protocols and reports. Provide training and oversight for support staff.

• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for equipment implementation. Drive Lean Transformation and Operational Excellence initiatives

Win

What we expect of you

Doctorate degree

OR

Master’s degree and 3 years of Quality, Operations or Process Development experience

OR

Bachelor’s degree and 5 years of Quality, Operations or Process Development experience

OR

Associate’s degree and 10 years of Quality, Operations or Process Development experience

OR

High school diploma / GED and 12 years of Quality, Operations or Process Development experience

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with these qualifications:

• Educational background in life sciences or equivalent

• Experience in a GMP controlled environment

• Availability to work in first or second shift once commercial production starts.

• Familiarity with equipment commissioning and qualification activities

• Affinity with digital innovation and data sciences

• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners

• Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues

• Strong organizational skills, including ability to follow assignments through to completion

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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