Manager Quality Assurance

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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 award-winning 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.

Manager Quality Assurance

What you will do

Lets do this! Lets change the world!

The IQA Manager will be a member of the Building 31 Plant QA team and will provide Quality oversight for the GMP Receiving function, including the review for release of incoming product and raw material shipments. The Incoming Quality Assurance (IQA) function is responsible for the review of transportation documentation, sampling of materials requiring testing for release, and the inspection and dimensional analysis of materials requiring that assessment for release. The IQA Manager will be responsible for leading and directing the IQA staff, being an informed Subject Matter Expert in IQA responsibilities, and maintaining a broad, general understanding of quality and compliance related competencies.

The IQA Manager will lead in a matrixed environment with informal performance accountability to multiple functions within Building 31. They may represent Quality on cross functional teams to achieve departmental goals and to foster a culture of Safety in the building.

Responsibilities include:

• Lead and direct Incoming Quality Assurance staff, including managing their performance and supporting their development.

• Provide real-time QA oversight and support for GMP Receiving operations. This currently extends to the receipt and review for release of product and raw material shipments in Building 31.

• Collaborate with the warehouse supply chain team to resolve quality and compliance issues identified in the operation and to support process improvements.

• Ensure that changes that could potentially impact product quality are assessed according to procedures (ex: change control, work order, etc.)

• Review and approve cGMP documents and records (e.g., Deviations, CAPAs, electronic batch record, change controls, SOP, etc.) ensuring compliance with appropriate documentation

• Alert senior management of quality, compliance, supply and safety risks

• Support and represent Quality during audits and inspections

• Support Lean Transformation and Operational Excellence initiatives

• Maintain the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements

• Ensure Quality Management System processes are executed in accordance with established procedures

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 individual with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Masters degree and 3 years of quality assurance experience OR

• Bachelors degree and 5 years of quality assurance experience OR

• Associates degree and 10 years of quality assurance experience OR

• High school diploma / GED and 12 years of quality assurance 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:

• Excellent interpersonal skills

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

• Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent

• Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry

• Proficient with database use, including data input, archival, and query retrieval

• Great attention to detail and high degree of accuracy in task execution and GMP documentation

• Highly effective verbal and written communication skills, strong interpersonal skills

• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

• Experience working with dynamic cross-functional teams and proven abilities in decision making

• Experience in management or leadership roles

• Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.

• Strong organizational skills, including ability to follow assignments through to completion

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 well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

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

for a career that defies imagination

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

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.

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