27 days old

Executive Director Site Quality Head

Amgen
West Greenwich, RI 02817
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  • Job Code
    129466605
Amgen

Job ID: R-111859
Location: West Greenwich, RI, US


    HOW MIGHT YOU DEFY IMAGINATION?

    At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

    Executive Director, Quality Site Head

    Live

    What you will do

    Let's do this. Let's change the world. In this vital role you will lead all aspects of the Quality function operations for the site. Responsibilities include leading the Site Quality Leadership Team, quality operations and support organizations, site quality resources and projects while assuring regulatory compliance. The ED Quality Site Head will report to the VP of Quality Operations.
    • Lead and direct all aspects of the Quality function for assigned Amgen site(s) including Quality Assurance, Quality Control (lab testing), Quality Compliance, and Quality Systems
    • Ensure that pharmaceutical drug substances, drug products, and combination products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations and specifications
    • Ensure that pharmaceutical drug substances, drug products, and combination products as used in early development studies are manufactured, tested, stored, and distributed according to phase-appropriate current Good Manufacturing Practices (cGMP) and other applicable regulations and specifications
    • Implement and maintain the Amgen Quality Management System across the site in accordance with corporate standards
    • Periodically review the Quality Management System and performance metrics to identify, report, address and correct all quality issues
    • Lead the Site Quality Leadership Team, and acts as site Quality representative for various site and global leadership forums and teams
    • Ensure that there is an adequate number of qualified personnel who possess an adequate combination of education, experience and training are provided to perform assigned Quality Unit functions in accordance with requirements and specifications
    • Ensure Quality oversight and Quality disposition (approval or rejection) of raw materials, pharmaceutical product, production records, documents and procedures
    • Serve as the site Quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd party auditors
    • Alert senior management of significant quality, compliance, supply and safety risks
    • Work in partnership with Manufacturing, Engineering, Process Development and Supply Chain leadership to assure quality of Amgen products comply with applicable regulations and specifications
    • Support Continual Improvement initiatives, programs and projects of the Quality System
    • Collaborate with other members of the Site Leadership Team in strategic planning, ensure goal alignment across the site
    • Develop a budget, manage expenditures, and oversee issue resolution
    • Represent the site at local community and civic functions
    • Coach and works with staff to establish career development plans and partner with HR to recruit, develop, retain and motivate outstanding staff
    • Develop safety goals and ensure they are communicated and achieved
    • Ensure an organizational structure capable of adapting to changing business needs and champion the Amgen value

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The Executiveprofessional we seek is a Quality site Leader with these qualifications:

    Basic Qualifications:
    • Doctorate degree and 6 years of Quality and/or Operations experience Or
    • Master's degree and 10 years of Quality and/or Operations experience Or
    • Bachelor's degree and 12 years of Quality and/or Operations experience And
    • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

    Preferred Qualifications:
    • 15+ years pharmaceutical/biotech industry experience in Quality, Manufacturing, Process Development, or Engineering
    • Persuasion and negotiation skills and the ability to interact successfully and partner with senior management within and outside of Quality
    • Excellent communication skills, both written and oral
    • Experience owning, tracking, and reporting on a department budget
    • Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes
    • Organizational savvy and presence to build effective relationships across functions
    • Demonstrated knowledge of cGMPs consistent with applicable international rules and regulations
    • Analytical/critical thinking skills with an experienced global perspective
    • Demonstrated team development and leadership skills
    • Self-motivated and highly driven leader; works as a team player and/or independently
    • Up to 25% Domestic and international travel may be required

    Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
    • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
    • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
    • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

    Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

    We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

    Amgen focuses on areas of high unmet medical need and uses 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 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.

    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.



    PI129466605
    Posted: 2021-01-29 Expires: 2021-03-01

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    Executive Director Site Quality Head

    Amgen
    West Greenwich, RI 02817

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