Manager Quality Assurance - PQA

Career Category

Quality

About the Opportunity

At Amgen, our shared mission—to serve patients—drives all that we do. Amgen is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina. The new plant will combine traditional stainless steel fed batch and single use technology ("FleX Batch" manufacturing), and integrate innovations to advance digitalization and sustainability, supporting Amgen's plan to be carbon neutral by 2027.

Manager Quality Assurance - PQA

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 support 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 regarding 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 with alignment and integration into the Amgen Quality Systems, including: interviewing candidates to build the ANC PQA team; authoring/reviewing/approving quality documents (SOPs, user requirements, risk assessments, training materials, engineering and automation documents, commissioning test protocols/reports, environmental & utility qualification protocols/reports, validation protocols/reports); overseeing execution of, and change management related to, factory acceptance, commissioning tests, facility qualifications and validation activities.
• 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 distributed according to cGMP, Good Documentation Practices (GDP) and other applicable regulations
• Participate in Inspection Readiness program activities
• Develop or contribute to the development of procedures and standards by which others will operate
• Develop and communicate goals and objectives to staff and key partners
• Monitor goal performance and coordinate action for improvement of team and overall PQA performance by championing operational excellence and Lean efforts
• 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 guidance and/or technical leadership
• Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change
• Review and approve operational and product manufacturing procedures, process validation protocols and reports, environmental characterization reports and change control documents
• 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, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

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

Preferred Qualifications

• Previous managerial experience directly managing people and/or 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 managing multiple, competing priorities in a fast-paced environment
• Demonstrated proficiency in written and verbal communication (including technical writing and presentations)
• Ability to communicate and collaborate effectively with technical and senior management staff within a site organization
• Experience and systems knowledge in manufacturing investigations, CAPA, product release, validation and/or change control
• Ability to develop meaningful team and staff goals, manage performance and coach
• Ability to manage timelines and deliver results to meet or exceed department goals
• Ability to solve complex problems and evaluate scientific data; decisive, independent risk-based decision-making on the floor

Benefits

• Full support and career-development resources to expand your skills and maximize your potential
• A diverse and inclusive community of belonging
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Salary Range

118,235.00 USD - 159,965.00 USD

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.