Quality Control Manager

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Quality Control Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for on-site management of Quality Control Bioanalytics team (Monday - Friday).

Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP).

The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.

Additional Responsibilities:

• Coordinates the scheduling and execution of testing including routine analysis and testing in support of technology transfer for product within the Bioanalytics Laboratories

• Provides technical expertise/guidance to lab staff and within cross-functional Amgen teams

• Leads the Bioanalytics Laboratory daily operations in relation to scheduling testing, project planning, management of materials, reagents, equipment, and laboratory staff

• Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioanalytics Lab activities

• Ensures lab operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls

• Represents the Bioanalytics Lab during Amgen internal/external audits and inspections.

• Direct interaction with regulatory agencies during on-site inspections

• Provides oversight of Bioanalytics Lab Quality Systems records including, lab investigations, Deviations, CAPAs and Change Controls

• Selects, develops, and evaluates laboratory staff to ensure functional objectives are met

• Handles assignment and accuracy of staff training

• Supports Continual Improvement and LEAN initiatives, programs and projects.

• Ensures that changes that could potentially impact product quality are assessed according to procedures.

• Ensures that deviations from established procedures are investigated and documented per procedures.

• Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements.

• Collaborates cross functionally as needed to ensure the Quality Management System processes are carried out in accordance with established procedures.

• Alerts senior management of quality, compliance, supply and safety risks.

• Supports internal/external audits and inspections as part of the audit/inspection management team.

What we expect of you

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

Basic Qualifications:

• High school diploma/GED and 12 years of Quality experience

• 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

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:

• Advanced degree in scientific field

• Strong knowledge in HPLC/UPLC, Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), and/or general chemistry testing including UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity

• Familiarity with technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines

• Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis

• Leadership capabilities and experience applying GMP requirements in a Quality Control setting

• Demonstrated ability to develop, coach and mentor employees

• Excellent interpersonal, verbal, and written communication skills with all levels within the organization

• Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment

• Ability to work in a team matrix environment and build relationships with partners.

• Identify, lead, and champion innovative projects to advance efficiency and enable LEAN principles across different functions.

• Establishment and review of department goals, strategies and KPIs.

• Experience with various laboratory equipment and computer systems

• Strong leadership and negotiation skills.

• Innovative thinking and ability to transform work organizations

• Exposure to Operational Excellence initiatives.

• Ability to coordinate multi-functional project teams and deliver on schedule.

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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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.

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.