Quality Assurance Senior Manager, Drug Substance

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Quality Assurance Senior Manager, Drug Substance

What You Will Do

Lets do this. Lets change the world. As a Quality Assurance Senior Manager, you will lead our Cell Bank QA and our B7 QA teams and will serve as the Quality Leader for Good Manufacturing Practices (GMP) Operations within the Cell Bank and the B7 commercial drug substance manufacturing facility. The QA Senior Manager will lead a team of QA staff, collaborate with cross-functional partners, and provide QA leadership and oversight in support of the operational teams key responsibilities which include:

• Meet site demands for cell bank production for clinical and commercial programs in the cGMP cell bank manufacturing area
• Meet site demands for drug substance intermediate production of a commercial product
• Identification and implementation of continuous improvement opportunities within our processes and systems
  
  
  

The QA Senior Manager will report to the Director of Quality Assurance for Drug Substance (DS) and be a member of the DS QA team that coordinates and contributes to serving Amgen patients via DS supply across all the ATO GMP facilities. As a member of this leadership team and as a member of the cross-functional leadership teams serving Cell Bank and B7, the QA Senior Manager will contribute to fostering and further developing the culture of Safety and Quality at ATO.

The job responsibilities will include but not be limited to:

• Staff Management - Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements, leads a culture of safety. Manages a team of QA professionals and prioritizes professional development of direct reports. Performs staff recruitment and selection, training, oversight, and performance evaluations according to Amgens talent management program.
• Quality Oversight and Leadership - Ensures the Quality Management System processes are implemented in accordance with established procedures. Provides direction and decision making for Quality system records and report such as investigations, CAPAs, Change Control. Reviews and approves records and reports. May serve as record or report owner. Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, and performed in accordance with established procedures and applicable regulations.
• Continuous Improvement - Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Amgen's Operational Excellence program to develop stronger capabilities in continuous improvement.
• Completes required assigned training to permit execution of required tasks
• Alerts senior management of significant quality, compliance, supply and safety risks
• May provide leadership and perform additional duties within other areas of the Quality Management System, including but not limited to: Management Review, Audits and Inspections, Change Control, Risk Management
  
  
  

What We Expect Of You

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

Basic Qualifications

• Doctorate degree and 2 years of quality assurance experience OR
• Masters degree and 6 years of quality assurance experience OR
• Bachelors degree and 8 years of quality assurance experience OR
• Associates degree and 10 years of quality assurance experience OR
• High school diploma / GED and 12 years of quality assurance experience
  
  
  

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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

• Excellent interpersonal skills
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
• Experience participating in, managing, and/or responding to health authority inspections, partner and corporate audits
• Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change
• Strong skills in data analysis skills and business case development
• Direct experience driving process improvements. Working knowledge of Operational Excellence, continuous improvement theory, Lean theory and/or Six Sigma
• Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development a plus
• Experience in Cell Banking operations, Cell Culture operations, protein purification and bioassays is a plus
• Experience with Quality Management Systems, including Change Control, Risk Management, Disposition
• Experience with Computer Systems such as MES, PI data historian, Delta-V automation systems
• Experience with Veeva for supporting investigations and CAPA
• Biology, Chemistry, or Engineering degree is desirable
  
  
  

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, well 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.

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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.