Sr Mgr Quality Control

Career Category

Job Description

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 awardwinning 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.

Senior Manager Quality Control

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:

• Oversight of the QC Microbiology Lab operations including Environmental Monitoring
• Responsible for presenting the QC Microbiology lab area during audits and inspections and directly interacting with regulators
• Lead laboratory troubleshooting and problemsolving exercises
• Oversight of Microbiology laboratory investigations
• Support the implementation of new equipment and technologies
• 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
• Interfaces 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.

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 quality experience

Or

Masters degree and 6 years of quality experience

Or

Bachelors degree and 8 years of quality experience

Or

Associates degree and 10 years of quality experience

Or

High school diploma / GED and 12 years of quality 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:

• 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 multifunctional project teams and deliver on schedule.
• Demonstrated ability to coordinate and lead crossfunctional 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.

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 wellbeing. 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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff plans
• Flexible work models including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Salary Range