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Manager QA

3 months ago

West Greenwich, United States Amgen Full time

**HOW MIGHT YOU DEFY IMAGINATION?**

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

**Manager, Quality Assurance**

**Live**

**What you will do**

Lets do this Lets change the world In this vital role you will responsible for Disposition of raw materials and product that ultimately serves patients. This centralized team also provides quality oversight for the ARI warehouse operations, including on the floor support, deviation, change control, and documentation review. Because all processes ultimately feed into the disposition process, the role offers opportunity to work broadly across the site and within the network. The ideal candidate will be a voice to influence and drive change at the network level as part of the global disposition network. The Manager, QA Disposition includes the following responsibilities:

**Responsibilities include the following:**

+ Leads and empowers a team of Quality professionals to ensure key deliverables related to disposition of raw materials and product are met.

+ Monitor key metrics related to the health of the disposition process.

+ Provide Quality Oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing.

+ Provide Quality Oversight to the Warehouse Floor operations including sampling, Dock operations, shipping, and Incoming/Receiving of Raw Materials.

+ Lead resolution of impactful events using risk based, balanced thinking and cross functional collaboration.

+ Provide Quality disposition advice in support of deviation and change control strategies.

+ Facilitate continuous improvement at the site and network level as it relates to the Disposition quality process.

+ Performs review and approval of cGMP processes, procedures, documents, and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations, Raw Materials and Drug Substance documentation.

+ Oversee the Raw Material Reject Cage.

+ Support Audits and Inspections

**Win**

**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 a self-starter with these qualifications.

**Basic Qualifications:**

+ In addition to meeting at least one of the below 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

+ High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience OR

+ Associates degree and 10 years Quality, Manufacturing, Process Development or Process Engineering experience OR

+ Bachelors degree and 5 years Quality, Manufacturing, Process Development or Process Engineering experience OR

+ Masters degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience OR

+ Doctorate degree

**Preferred Qualifications:**

+ Previous quality operations experience, preferably in quality operations (PQA, QC, Quality Systems, Compliance)

+ Demonstrated leadership ability

+ Experience with key quality processes including deviation/capa, change control, and testing

+ Experience with key computer related systems: Trackwise, SAP, BTRS, and Lab Information Management System

+ Demonstrated ability to apply risk based thinking to decision making

+ Solution focused

+ Ability to effectively communicate and collaborate with cross functional teams, network peers, and management.

**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 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.

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.

**careers.amgen.com**

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.