Manager Quality Assurance PQA

HOW MIGHT YOU DEFY IMAGINATION

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills experience and passion to work toward your goals At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over 10 million patients worldwide. Come do your best work alongside other innovative driven professionals in this meaningful role.

Live

What you will do

Does the thought of building an entirely new site from the ground up excite you Do you love cultivating sustainable systems and high performing teams If you have a passion execution excellence and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.

Amgen one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs North Carolina a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats traditional stainless steel fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing which makes the facility more dynamic and efficient as well as requiring a smaller physical footprint than a traditional plant. Additionally the plant will integrate innovations to advance digitalization and sustainability aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.

Lets do this. Lets change the world.

In this dynamic role you will be the Manager Quality Assurance for the PQA team and will work directly with plant manufacturing and engineering staff during the Amgen North Carolina (ANC) facility startup and transition to on-going bulk drug substance manufacturing including development clinical launch and commercial operations.
The Manager Quality Assurance will hire train develop and manage Quality Assurance professionals to successfully deliver on role to support (Good Manufacturing Practices) GMP Manufacturing and to oversee and manage change in an effective efficient and compliant manner. This includes partnership with Manufacturing Facilities & Engineering and other support functions providing coaching guidance and direction in regards to deviations quality systems and compliance aspects.

The initial focus of this role will be on the ANC startup to prepare the new facility for Operational Readiness.

*Candidate will be working on site supporting a shift working schedule to include late afternoon and nights. Role for Second shift (Example 2pm-10:30pm).

Responsibilities:

• Oversee ANC startup activities for facilities utilities equipment systems and processes
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• Manage a team of PQA staff and their daily operations (verify training schedules ongoing tasks prioritization and support needed)
• Oversee staff/team performance
• Prioritize and support staff development
• Provide on-going Quality oversight to ensure products are manufactured tested stored and
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• Participate in Inspection Readiness program activities to ensure facilities equipment materials organization processes and procedures comply with cGMP practices and other applicable regulations
• Develop or contribute to the development of procedures and standards by which others will
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• Develop and communicate goals and objectives to staff and key partners
• Monitor goal performance and coordinate action for improvement of team and overall Plant
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• Assist project teams in establishing priorities project timelines and in securing resources
• Actively represent Quality Assurance on incident triage teams or support efforts by providing
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• Partner with internal personnel at various management levels to resolve issues establish
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• Review and approve operational and product manufacturing procedures process validation
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• Support site audits and inspections.

Basic Qualifications

• Doctorate degree OR
• Masters degree and 3 years of Quality experience OR
• Bachelors degree and 5 years of Quality experience OR
• Associates degree and 10 years of Quality experience OR
• High school diploma / GED and 12 years of Quality experience

In addition to meeting at least one of the above requirements you must have experience directly managing people and/or leadership experience leading teams projects prograns or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

* Experience can also include Manufacturing Operational Excellence Engineering and/or Data/Information Systems experience

Preferred Qualifications

• Previous managerial experience directly managing people and/or experience leading teams
  projects programs or directing the allocation of resources
• Experience and training in CDOCS Trackwise Maximo LIMS MES Werum and other systems and applications
• Experience in managing multiple competing priorities in a fast-paced environment
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate clearly facilitate discussions and present to audiences at all levels of the organization.
• a site organization with ability to communicate and collaborate effectively with technical and senior management staff.
• Experience and systems knowledge in areas of manufacturing investigations Corrective Actions/Preventative Actions (CAPA) product release validation and/or change control
• Ability to develop meaningful team and staff goals manage performance and coach and
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• Ability to manage timelines and deliver results to meet or exceed department
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• Ability to solve complex problems and evaluate scientific data. Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs.

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 benefitswith 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.

#AmgenNorthCarolina

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering developing manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

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