Manager Quality Assurance - PQA

Amgen•Holly Springs, NC

1d•Onsite

About The Position

The Manager Quality Assurance for the PQA team will work with plant manufacturing and engineering staff during the Amgen North Carolina facility startup and transition to ongoing bulk drug substance manufacturing, including development, clinical, launch, and commercial operations. The manager will hire, train, develop, and manage Quality Assurance professionals supporting GMP manufacturing and effective, efficient, compliant change management. The role partners with Manufacturing, Facilities & Engineering, and other functions to provide coaching and guidance on deviations, quality systems, and compliance. The initial focus is preparing the new facility for Operational Readiness. PQA staff work onsite and support 24/7 operations through different shift structures. After startup, the manager is expected to move to a shift schedule that includes weekends and is intended to cover first-shift hours, from very early morning through mid-afternoon. Specific hours depend on operational needs. The role oversees facility startup activities and quality oversight, manages team operations and performance, supports inspection readiness, and contributes to procedures, operational excellence, project delivery, incident response, audits, and inspections. It reviews and approves manufacturing and quality documents, protocols, reports, and change controls to support compliant manufacture, testing, storage, and distribution.

Requirements

Meet one of the following education and Quality experience combinations: high school diploma or GED and 12 years of Quality experience; associate degree and 10 years; bachelor's degree and 5 years; master's degree and 3 years; or doctorate degree.
Have experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing allocation of resources. Managerial experience may run concurrently with the required technical experience.

Nice To Haves

Scientific degree in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies.
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.
Experience leading and/or managing teams.
Demonstrated written and verbal communication skills, including technical writing and presentations, and ability to collaborate effectively with technical and senior management staff.
Quality assurance or combined quality and manufacturing experience in the biotechnology or pharmaceutical industry.
Experience and systems knowledge in manufacturing investigations, CAPA, product release, validation, and/or change control.
Experience with regulations, standards, and guidelines that apply to biotech manufacturing in a multi-product environment.
Ability to develop meaningful team and staff goals, manage performance, and coach and develop staff.
Ability to manage timelines and deliver results to meet or exceed department and company goals and objectives.
Ability to communicate clearly, facilitate discussions, and present to audiences at all levels of a site organization.
Ability to solve complex problems and evaluate scientific data.
Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs.

Responsibilities

Oversee startup activities for facilities, utilities, equipment, systems, and processes, integrating them with Amgen Quality Systems.
Interview candidates and build the ANC PQA team.
Author, review, and approve quality documents, including SOPs, user requirements, risk assessments, training materials, engineering and automation documents, commissioning test protocols and reports, environmental and utility qualification protocols and reports, and validation protocols and reports.
Oversee execution of and change management for factory acceptance, commissioning tests, facility qualifications, and validation activities.
Manage PQA staff and daily operations, including training verification, schedules, ongoing tasks, prioritization, and support needs.
Oversee staff and team performance and prioritize staff development.
Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP, and other applicable regulations.
Participate in Inspection Readiness activities to ensure facilities, equipment, materials, organization, processes, and procedures comply with cGMP and other applicable regulations.
Develop or contribute to procedures and standards by which others will operate.
Develop and communicate goals and objectives to staff and key partners.
Monitor goal performance and coordinate improvement actions for team and overall PQA performance, championing operational excellence and Lean efforts.
Assist project teams with priorities, timelines, and securing resources.
Represent Quality Assurance on incident triage teams or provide guidance and technical leadership to support incident response.
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.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.