Manager QA - Drug Substance (Night Shift)

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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 award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

MANAGER QA - DRUG SUBSTANCE OPS (NIGHT SHIFT)

What you will do

Let’s do this. Let’s change the world! In this vital role in support to Amgen’s Quality Assurance program, we are seeking a highly motivated and proactive leader to join us as Manager QA, to lead and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico in a non-standard shift operation (night shift).

Specific responsibilities include but are not limited to:

• Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management.
• Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations.
• Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards.
• Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays.
• Approve Master Production Records (MPs), process validation protocols and reports, Environmental Characterization reports, and planned incidents.
• Represent QA in New Product Introduction (NPI) teams and during audits and inspections.
• Lead investigations and plant audits; approve change-over completion activities.
• Ensure deviations are properly investigated and documented; verify accuracy and completeness of production records and test results.
• Collaborate cross-functionally to ensure QMS processes follow established procedures.
• Bring up quality, compliance, supply, and safety risks to senior management.
• Ensure controlled documents have assigned owners and that periodic reviews are completed on time.

What we expect of you

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

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of experience in regulated industry experience

Or

Bachelor’s degree and 5 years of experience in regulated industry experience

Or

Associate’s degree and 10 years of experience in regulated industry experience

Or

High school diploma / GED and 12 years of experience in regulated industry experience

In addition to meeting at least one of the above requirements, you must have 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:

• Educational background in Life Sciences or Engineering
• Experience with processes involved with Quality Assurance, manufacturing and distribution, Quality Control, validation, and process development.
• Validated expertise in Quality Systems such as Deviations, CAPA and Change Control
• Experience leading cross functional teams with the influencing and negotiating skills
• Strong organizational, project management and change management skills
• Strong communication skills (both written and oral), and comprehend in English and Spanish
• Ability to provide direction and establish goals for individual staff members and work groups, empower staff, manage and distribute workloads.
• Ability to interact with regulatory agencies

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.

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:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 an annual site shutdown
• Flexible work models, including remote work arrangements, where possible

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

careers.amgen.com

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Sponsorship

Sponsorship for this role is not guaranteed.

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 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.