Manager QA

Amgen Inc. Thousand Oaks , CA 91360

Posted 7 months ago

Career Category

Quality

Job Description

The QA Manager will be a member of the Drug Substance Plant QA team and will provide Quality oversight for Drug Substance Manufacturing and support Facilities & Engineering operations. Examples of Drug Substance manufacturing operations include Cell Bank, Cell Culture, and Purification. The individual will contribute to fostering the culture of Safety and Quality at ATO. The QA manager provides Quality and Compliance oversight for the operational staff during execution of GMP processes, procedures, and use of the Amgen Quality Management System.

The QA manager will lead team of Quality professionals with a strong focus on staff development, ensuring product quality, and building the best team. The QA Manager will also lead cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals, to ensure on-time patient supply of high-quality medicines, and to improve compliance and inspection readiness in operational areas of responsibility.

Responsibilities include:

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

  • Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner

  • Observes GMP operations within a clean room environment and provides appreciative and constructive feedback to staff and managers

  • Reviews and provides Quality approval for electronic batch records, and GMP documentation such as revisions to procedures and GMP documents, work orders, investigation reports, change control records, corrective action / preventive action records, and other GMP records

  • Alerts management of significant quality, compliance, supply and safety risks

  • Participates as a QA team member during regulatory inspections, third party audits, and internal audits

  • Makes certain the Quality Management System processes are executed in accordance with established procedures

  • May author and own cGMP documents and reports

  • May also perform other duties as assigned

  • May serve as a team member with cross-functional colleagues on internal audits

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

AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

  • Excellent interpersonal skills

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

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

  • Experience with cGMP production environments. Direct work experience with cGMP processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development

  • Experience participating in, managing, and responding to corporate audits/regulatory inspections

  • Experience with TrackWise for supporting investigations and CAPA

  • Experience with Quality Management Systems, including Change Control, Risk Management, Disposition

  • Demonstrated ability to work as both a team player and independently

  • Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change

  • Biology, Chemistry, or Engineering degree

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
QA Sr Manager Device Site Lead

Amgen Inc.

Posted 2 months ago

VIEW JOBS 1/12/2020 12:00:00 AM 2020-04-11T00:00 Career Category Quality Job Description This QA Sr. Manager role will be responsible for the quality oversight of one or more device suppliers. This person is an integral member of the Amgen cross-functional device supplier team that includes, but is not limited to, business operations, final product technologies, process development, supply chain and final product technologies quality. Key Responsibilities * Quality liaison between Amgen and the device supplier * Negotiator and Approver of quality agreements * Prepare external site for inspections including development of inspection playbooks. * Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during Notified Body audits of supplier, as applicable or required * Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas * Review/Approve supplier investigations, event and change notifications * Quality approver of deviations, change controls, CAPA, CAPA EVs * Identify and mitigate risk at the supplier and/or escalate to management * Perform Person in Plant activities as required * Manage audit commitments to completion * Perform tactical batch disposition activities in support of lot release * Continuously assess supplier status through periodic monitoring reporting * Partner with Operations site lead on issues, improvements, site performance and overall relationship management * Domestic and international travel required - on average ~20% Basic Qualifications Doctorate degree and 2 years of Quality experience OR Master's degree and 6 years of Quality experience OR Bachelor's degree and 8 years of Quality experience OR Associate's degree and 10 years of Quality experience OR High school diploma / GED and 12 years Quality experience Preferred Qualifications * 10 + years biotech or pharmaceutical industry experience * Experience with Quality Processes and systems such as QMTS and IRPC * History of involvement with inspection and audits * Able to facilitate and influence senior stakeholders and partners * Able to successfully manage workload and timelines * Familiarity with basic project management tools * Ability to negotiate a strategic position after taking feedback from multiple sources * Strong project management, problem-solving, and analytical skills * Strong influencing skills * Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results * Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution * Ability to operate in a matrixed or team environment with site, functional, and executive leadership * Experience driving decision making by using DAI principles * Experience with relationship management with external parties * Experience with the "variation management" process Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 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, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. 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, or disability status. . Amgen Inc. Thousand Oaks CA

Manager QA

Amgen Inc.