Manager Quality Assurance - PQA

Amgen•Holly Springs, NC

3d•$118,235 - $159,965•Onsite

About The Position

The Manager Quality Assurance will lead the Plant Quality Assurance (PQA) team and work directly 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 initial focus is preparing the new facility for operational readiness. PQA staff work on-site, and the team supports 24/7 operations through different shift structures. Following the startup phase, 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 hires, trains, develops, and manages Quality Assurance professionals who support GMP manufacturing and effective, compliant change management. It provides quality oversight and guidance to Manufacturing, Facilities & Engineering, and other support functions on deviations, quality systems, and compliance. The manager oversees facility startup and qualification activities, manages team operations and performance, and supports ongoing compliance, inspection readiness, audits, and manufacturing quality activities.

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 resource allocation. 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 with 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.
Strong written and verbal communication skills, including technical writing and presentations, and the ability to collaborate effectively with technical and senior management staff.
Quality assurance experience, or a combination of quality and manufacturing experience, in the biotechnology or pharmaceutical industry.
Systems knowledge or experience in manufacturing investigations, CAPA, product release, validation, and/or change control.
Experience with regulations, standards, and guidelines applicable to biotech manufacturing in a multi-product environment.
Ability to develop team and staff goals, manage performance, and coach and develop staff.
Ability to manage timelines and deliver results that meet or exceed department and company 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, with decisive, independent, risk-based decision-making on the manufacturing floor.

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 factory acceptance, commissioning tests, facility qualifications, validation activities, and related change management.
Manage PQA staff and daily operations, including training verification, schedules, task prioritization, and staff support.
Oversee staff and team performance and prioritize staff development.
Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with 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 for others to follow.
Develop and communicate goals and objectives to staff and key partners; monitor performance and coordinate improvement actions.
Champion department operational excellence and Lean efforts to improve PQA performance.
Assist project teams with priorities, timelines, and securing resources.
Represent Quality Assurance on incident triage teams and provide guidance 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.