Senior 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.

Senior Manager Quality Assurance

What you will do

Lets do this! Lets change the world!

The Senior Manager Site Quality Operations (SQO) effectively manages the daily work of direct reports responsible for the quality oversight of sitewide support functions for the Thousand Oaks site, including the Incoming QA function for raw materials and components, and a small group of Quality Management System (QMS) Specialists. The Senior Manager SQO will be responsible for advancing the quality systems, for overseeing incoming material batch record review and release as well as IQA investigations and change controls.

Key responsibilities:

• Ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.

• Keep up to date with emerging trends and regulatory advances in the areas of incoming raw materials and components.

• Ensure reliable, discerning and timely Quality disposition of raw materials and components, and Amgen transferred shipments of cell bank, drug substance, drug product, and finished drug product.

• Ensure QMS processes are appropriately designed, implemented and managed across the ATO site to ensure they are fit for purpose for effective phase appropriate practices in Process Development, Clinical and Commercial functions.

• Ensure QMS site process owners maintain voice of customer engagement with process end users along with maintenance and execution of an annual site Quality Process improvement plan describing continuous improvement and productivity initiatives, programs and projects based on execution performance

• Ensure Quality processes in scope are monitored and a process health summary is provided to site leadership on a routine basis.

• Ensure appropriate staff development and training in areas of responsibility.

• Perform review, approval and tracking of cGMP processes, procedures and records, including but not limited to Deviations, CAPAs, change controls, and validation records.

• Champion Continuous Improvement initiatives, programs and projects.

• Ensure that changes that could potentially impact product quality are assessed according to procedures.

• Ensure that deviations from established procedures are investigated and documented.

• Ensure that IQA records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

• Ensure that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.

• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and performed in accordance with established procedures and applicable regulations. Partner with other Amgen sites in the network to ensure consistency and continuous improvement.

• Ensure appropriate escalation of key QMS risks and accomplishments to senior management, through Management Review.

• Lead inspection readiness activities for the areas.

• Participate in Amgen internal/external audits and inspections, potentially interacting directly with regulatory and/or third party auditors.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dyanmic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of quality assurance experience OR

• Masters degree and 6 years of quality assurance experience OR

• Bachelors degree and 8 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 a minimum of 2 years 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:

• 5+ years of Quality experience

• 2+ years of Management at a senior quality level

• Experience interacting with multiple sites

• Working/detailed knowledge of GMPs and global QA requirements as related to aseptic processing in US and multiple jurisdictions

• Strong leadership capabilities and proven experience applying GMP requirements in an operational setting

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

• Strong level of analytical skills to evaluate and interpret information to arrive at logical and quality-minded conclusions balanced with a willingness to take informed and appropriate risks.

• Computer Skills: Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe Acrobat; database related platforms; knowledge of Electronic Document Management System (EDMS)

• Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.

• Ability to plan, monitor, and control a set of projects, ensuring efficient utilization of resources to achieve program objectives

• Good organizational skills, effective project and time management skills, and ability to work well under pressure.

• Innovative approach with aptitude for developing ideas into actionable objectives

• Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus

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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