Manager Quality Assurance - PQA

Amgen Inc.; Holly Springs (NC); On-site; USD 118,000 - 160,000; Full time

Benefits offered by this job

Retirement plan

Medical/Dental/Vision

Life and disability insurance

Flexible spending accounts

Annual bonus program

Stock-based incentives

Generous time-off

Job summary

Amgen Inc. is seeking a Manager Quality Assurance – PQA to lead the Plant Quality Assurance team for ANC startup activities and ongoing 24/7 support. You will oversee quality documents, validation tasks, and change control while ensuring compliance with cGMP and GDP.

You will manage staff, drive process improvements, and participate in inspection readiness, partnering with diverse teams to meet safety and quality goals across manufacturing operations.

Qualifications

• High school diploma / GED with 12 years quality experience.
• Associate’s degree with 10 years quality experience.
• Bachelor’s degree with 5 years quality experience.
• Master’s degree with 3 years quality experience.
• Doctorate degree.

Responsibilities

• Staff for the PQA team are on-site workers and support 24/7 operations.
• Oversee startup activities for facilities, equipment, and systems and ensure alignment with quality systems.
• Lead a team of PQA staff, manage schedules, and provide ongoing quality oversight.
• Develop and communicate procedures and standards for operations and quality.
• Support site audits, inspections, and incident triage as needed.

Skills

People management

Leadership

Quality assurance

Communication

Project management

Team collaboration

Education

Bachelor degree

Master degree

Doctorate

Associate degree

Tools

CDOCS

Trackwise

Maximo

LIMS

MES Werum

Job description

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.

• 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
• Associate’s degree and 10 years of Quality experience
• Bachelor’s degree and 5 years of Quality experience
• Master’s degree and 3 years of Quality experience
• 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 benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range 118,235.00USD -159,965.00 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen