Quality Assurance Manager
Quality Assurance Manager
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$ 129509 - 129509
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Job Description
Career Category
QualityJob 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.
Quality Assurance Manager
What you will do
Lets do this! Lets change the world!
Amgen is searching for a Quality Manager site lead who will be responsible for Quality and Compliance oversight of contract manufacturing/testing sites. This Quality Manager will have significant responsibility working with supplier quality and manufacturing. The Quality Manager will also provide support to Quality Senior Manager site leads.
The Quality Manager will report into External Supply Qualitys North American regional team. This role can be filled in multiple locations in the United States.
Key responsibilities for this role include:
Be an integral quality partner of Amgens crossfunctional external supply team that includes: business operations analytical sciences process development and supply chain.
Perform general oversight and periodic evaluations of Quality performance for contract manufacturing/testing sites
Negotiate Quality Agreements (QAGR) and ensure adherence to QAGR terms.
Review and approve master batch records deviations change controls CAPAs CAPAEVs and Product Complaints
Provide data for Annual Product Review (APR)
Support audits/inspections (e.g. prepare topics to be presented during inspections). Support management of audit/inspection commitments to completion
Ensure inspection readiness (e.g. prepare playbooks participate in mock inspections)
Identify and mitigate risks at supplier site and raise to management as appropriate
Perform tactical batch disposition activities in support of lot release
Role may require occasional travel
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 2 years of quality or manufacturing experience OR
Bachelors degree and 4 years of quality or manufacturing experience OR
Associates degree and 8 years of quality or manufacturing experience OR
High school diploma / GED and 10 years of quality or manufacturing experience
Preferred Qualifications:
Bachelors of Science degree
8 years biotech or pharmaceutical industry experience
Significant Quality and/or Manufacturing experience at small and/or large molecule DS DP or FDP manufacturing facilities. Experience with synthetics/small molecules a plus.
Ability to facilitate and influence senior partners and balance workload and timelines
Ability to negotiate a strategic position after taking feedback from multiple sources
Strong project management (PM) problemsolving and analytical skills and familiarity with PM tools
Experience with analytical testing situations (e.g. method transfers analytical qualifications stability lab investigations in process testing release testing)
Shown ability to lead crossfunctional teams consistently deliver timely and quality results
A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issue to resolution
Ability to operate in a matrixed or team environment with site functional and executive leadership
Skilled in using risk based decisionmaking approaches
Experience with the regulatory activities and variation management
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 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. 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.
.Salary Range
109307.00 USD 129509.00 USDRequired Experience:
Manager
Employment Type
Full-Time
