Quality Assurance Manager

Career Category

Job Description

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.

QA Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will oversee the daily operations of the quality assurance team, ensuring that the company's products meet established quality standards. They implement and manage QA systems, coordinate audits, and lead initiatives to address and prevent quality issues.

Responsibilities:

• Partner with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of quality and safety and ensuring the facility operates successfully, efficiently, compliantly, and safely.

• Provide quality oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.

• Lead the quality assurance team with a focus on strategic direction, staff development, and maintaining a high-performance culture.

• Champion quality initiatives and collaborate with cross-functional teams to drive and deliver continuous improvement projects.

• Process optimization - assess and optimize quality processes to enhance efficiency and effectiveness

• Ensure compliance with cGMP practices and regulatory requirements.

• Provide leadership and support during both internal/external audits and inspections and audits. Will directly interact with regulatory agencies during on-site inspections.

• Develop and manage training programs to ensure team competencies and understanding of cGMP requirements.

• Manage quality-related issues effectively, ensuring solutions are implemented to prevent recurrence.

• Evaluate team performance and provide coaching to support career growth and professional development.

• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.

• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.

• Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.

• Flexibility to cover different shifts as required by the 24/7 facility production schedule. This role could support a day or swing shift schedule, including partial weekend coverage as part of the standard shift structure.

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.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 3 years of quality experience OR

• Bachelor’s degree and 5 years of quality experience OR

• Associate’s 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 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:

• Bachelor’s Degree in Science

• 5 plus years of aseptic processing experience in QA or Manufacturing

• Regulatory Knowledge: Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements.

• Leadership Skills: Strong leadership and people management skills, with the ability to mentor, develop, and motivate a team.

• Analytical Thinking: Excellent analytical and problem-solving skills, with the ability to make sound decisions based on data.

• Communication Skills: Exceptional communication and interpersonal skills, with the proficiency to interact effectively with all levels of the organization and external partners.

• Attention to Detail: High attention to detail and the ability to manage multiple priorities in a fast-paced environment.

• Continuous Improvement: A commitment to continuous improvement and staying current with the latest industry trends and best practices.

• Aseptic Knowledge: Expertise in aseptic processing and cleanroom operations, with a focus on maintaining sterility and preventing contamination.

• Risk Management: Ability to identify, assess, and mitigate risks to product quality and patient safety.

• Operational Excellence: Experience in supporting manufacturing operations, with a focus on efficiency, compliance, and safety.

• Collaboration: Proven ability to develop strong partnerships and work collaboratively with cross-functional teams, including manufacturing and Facilities & Engineering (F&E) colleagues.

• Audit and Inspection Readiness: Experience in preparing for and leading audits and inspections by regulatory authorities.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll 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 sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models, including remote and hybrid work arrangements, where possible

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

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying 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.

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 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. 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.

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