Career CategoryQuality
Job DescriptionManager Quality Assurance- PQAIn 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
- Master's degree and 3 years of Quality experience OR
- Bachelor's degree and 5 years of Quality experience OR
- Associate's 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 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.
careers.amgen.com #AmgenNorthCarolina
Salary Range118,235.00USD -159,965.00 USD
