Manager Quality Assurance - PQA

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

MANAGER QUALITY ASSURANCE – PQA

What you will do

• Let’s do this. Let’s change the world. In this vital 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.

* Staff for the PQA team are on-site workers.

The Plant Quality Assurance team will work different shift structures to provide ongoing support to our functional teams and 24/7 operations. After the facility startup phase, the successful incumbent will be expected to transition to a shift working schedule, including weekends, and is intended to serve 1st shift hours (very early morning through mid-afternoon). Specific hours will be determined based on operational needs.

• •Oversee ANC startup activities for facilities, utilities, equipment, systems and processes
• •with alignment and integration into the Amgen Quality Systems, including: Interview
• •candidates to build the ANC PQA team, Author/review/approve quality documents, related
• •to: Standard Operating Procedures (SOPs), user requirements, risk assessments, training
• •materials, engineering documents, automation documents, commissioning test
• •protocols/reports, environmental & utility qualification protocols/reports, validation
• •protocols/reports, Oversee execution of, and change management related to, the following:
• •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 current Good Manufacturing Practices (cGMP), Good Documentation
• •Practices (GDP) and other applicable regulations
• •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
• •operate
• •Develop and communicate goals and objectives to staff and key partners
• •Monitor goal performance and coordinate action for improvement of team and overall Plant
• •Quality Assurance (PQA) performance by championing department 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 for manufacturing processes, environmental characterization reports
• •and change control documents.
• •Support site audits and inspections.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications:

• •High school diploma / GED and 12 years of Quality experience OR
• •Associate’s degree and 10 years of Quality experience OR
• •Bachelor’s degree and 5 years of Quality experience OR
• •Master’s degree and 3 years of Quality experience OR
• •Doctorate degree

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, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• •Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
• •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
• •Experience leading and/or managing teams
• •Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
• •Quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry
• •Experience and systems knowledge in areas of manufacturing investigations, Corrective Actions/Preventative Actions (CAPA), product release, validation and/or change control
• •Experience in 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

A comprehensive employee