Senior Manager Quality Control

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.

Senior Manager Quality Control

Live

What you will do

Lets do this! Lets change the world! In this vital role, you will lead the Amgen Thousand Oaks, Quality Control Microbiology Laboratories. This is a unique opportunity to learn about and support testing of Amgen products through various stages of the product lifecycle. The QC Senior Manager will report directly to the Director of Quality Control and as a member of the QC leadership team will contribute to fostering and further developing a culture of safety, quality and compliance.

The QC Senior Manager will be accountable for the following functions in support of core QC laboratory operations:

Microbiology Laboratory:

• Responsible for effectively managing the day-to-day operations of the QC Microbiology lab

• Maintains laboratory schedule to support testing of validation, in-process, release and stability sample types applying various Microbiology-based test methods

• Ownership of site and global procedures related to Microbiology lab testing and processes

• Responsible for presenting the QC Microbiology lab area during audits and inspections and directly interacting with regulators

• Lead laboratory troubleshooting and problem-solving exercises

• Oversight of Microbiology laboratory investigations

• Implementation of new equipment and technologies

• Management of direct reports including the QC Environmental Monitoring Lab Manager

• Support staff training, career development and performance management

• Responsible for ensuring compliance with safety guidelines, cGMPs and other applicable regulatory requirements.

Additional Responsibilities:

• Participate in Amgen global network teams

• Establish and enable LEAN principles across area of responsibility

• Establish and enable department goals, strategies and KPIs

• Champion site and QC global process improvements

• Collaborate with management on significant matters, often requiring the coordination of activity across organizational units

• Plans and organizes project assignments of substantial variety and complexity

• Translates complex data into actionable information and applies strong technical knowledge to meet business objectives

• Identifies process gaps, introduces innovative solutions, and leads operational excellence projects to improve efficiency and productivity, while decreasing expense/operating costs.

• Leads root cause analysis discussions for more complex problems to develop and efficiently implement effective permanent solutions.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a strong leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of related experience

Or

Masters degree and 6 years of related experience

Or

Bachelors degree and 8 years of related experience

Or

Associates degree and 10 years of related experience

Or

High school diploma / GED and 12 years of related 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:

• Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control.

• Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources.

• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners.

• Track record of building or participating as a member of high performing team.

• Experience in leading and owning complex investigations.

• Experience in auditing and defending processes, procedures and decisions during regulatory inspections.

• Experience with various laboratory computer systems and applications.

• Strong leadership and negotiation skills with a demonstrated ability to influence different styles.

• Demonstrated innovative thinking and ability to transform work organizations.

• Strong technical writing skills within a highly regulated environment.

• Exposure to Operational Excellence initiatives.

• Understanding of quality management systems and quality control processes related to drug substance and drug product for clinical and commercial operations.

• Demonstrated ability to navigate through ambiguity and provide structured problem solving.

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

• Demonstrated ability to coordinate and lead cross-functional teams.

• Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization.

• Demonstrated skills in staff motivation, coaching/mentoring and professional development.

• Great teammate who is able to collaborate and provide leadership through influence to achieve the required results.

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.

The annual base salary range for this opportunity in the U.S. is $126,081 - $155,021.

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

Apply now

for a career that defies imagination

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

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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.