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 SubstanceLive
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
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.
Doctorate degree and 2 years of Quality or Operations experience
Masters degree and 6 years of Quality or Operations experience
Bachelors degree and 8 years of Quality or Operations experience
Associates degree and 10 years of Quality or Operations experience
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
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
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
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.