Sr Manager, QA Drug Product
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Sr Manager, QA Drug Product
What you will do
Let’s do this! Let’s change the world!
Reporting to the QA Director, the QA Senior Manager, Drug Product, effectively manages the daily work of direct reports responsible for the quality oversight of Drug Product Formulation and aseptic Fill Finish activities in the Drug Product Manufacturing facility at Amgen, Thousand Oaks. The QA Senior Manager will also be responsible for advancing quality systems, batch record review, investigations and managing change within the Drug Product facility.
Key responsibilities Include;
Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
Ensures that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.
Keeps up to date with emerging trends and regulatory advances in the areas of aseptic processing and drug product inspection and ensures appropriate staff development and training in areas of responsibility.
Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Deviations, CAPAs, and validation activities.
Champions Continuous Improvement 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
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
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.
Alerts senior management of significant quality, compliance, supply and safety risks, often requiring the coordination of activity across organizational units. Exercises judgment
Represents the quality unit during audits and inspections as needed.
Supports internal/external audits and inspections as part of the audit/inspection management team as needed.
Completes required assigned training and manages team training to permit execution of required tasks.
Performs additional duties as specified by 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 experience
Master’s degree and 6 years of Quality experience
Bachelor’s degree and 8 years of Quality experience
Associate’s degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
5 years of Quality experience, with at least 2 years of Management at a senior quality level
Experience in aseptic processing, sterilization practices and processes.
Experience interacting with multiple sites
Working/detailed knowledge of GMPs and global QA requirements as related to aseptic processing in US and multiple jurisdictions.
Proven leadership and organizational skills.
Skilled in technical writing and critical thinking.
Computer Skills: Microsoft Excel, Word, Power Point, Smartsheet; Adobe Acrobat; database related platforms.
Good organizational, communication and presentation skills, effective project and time management skills, and ability to work well under pressure.
Highly organized with excellent attention to detail.
Motivated, self-directed, able to work autonomously but also with proven ability to work in a team environment
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.
The annual base salary range for this opportunity in the U.S. is $143,192 – $170,286.
In addition to the base salary, 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.
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, 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.
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