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Quality Assurance Senior Manager, Drug Substance

Employer
Amgen
Location
Thousand Oaks, California
Start date
Nov 17, 2023

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Quality Assurance Senior Manager, Drug Substance

Live

What you will do

Lets do this! Lets change the world!

Are you looking for a meaningful new opportunity to test and growth your leadership skills? We have an immediate need for a Quality Assurance (QA) Senior Manager to join our team at Amgen, Thousand Oaks CA. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support of our mission to serve patients.

Amgen is a leading global biotechnology company, with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses. Our medicines have made a dramatic difference in the lives of millions.

As a Quality Assurance Senior Manager, you will lead our B23 Drug Substance QA team and will serve as the Quality Leader for Good Manufacturing Practices (GMP) Operations within the B23 Drug Substance Clinical and Commercial 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 drug substance production for clinical and commercial programs in the cGMP manufacturing area

  • 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 Drug Substance supply, 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

Win

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 employee with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Quality or Operations experience

Or

Masters degree and 6 years of Quality or Operations experience

Or

Bachelors degree and 8 years of Quality or Operations experience

Or

Associates degree and 10 years of Quality or Operations experience

Or

High school diploma / GED and 12 years of Quality or Operations experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

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 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 the teachings of Dr W. Edwards Deming, Operational Excellence, Six Sigma, Lean a plus

  • 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 TrackWise for supporting investigations and CAPA

  • Biology, Chemistry, or Engineering degree is desirable

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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 and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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