1+ months

Senior Manager & Site Lead Information Systems

Amgen
Woburn, MA 01801
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  • Job Code
    120804739
Amgen

Job ID: R-100406
Location: Woburn, MA, US 01806

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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in our detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and an unyielding focus on safety, quality, and compliance.

This role of Senior Manager, Information Systems (IS) for AWM reports directly to the Head of Manufacturing IS and dotted line to the AWM Site Head. In this role, the Sr. Manager has responsibility for leading a team of business analysts supporting the site business functions.

Responsibilities:
  • Provides leadership for the Information Systems department, delivering technical oversight to all application delivery, maintenance and integration. Oversee local IS talent management, including performance, career development, and succession planning.
  • Plays a critical role in building and maintaining strong business partnership with the Manufacturing site leadership team at the Woburn, Massachusetts site.
  • Ensures Information System services continue to support the business goals and processes, working closely with the IS Service Owners and teams, across the full IS lifecycle: influencing strategy, supporting project delivery and ensuring effective support, as well as handling raised issues and resolving problems.
  • Mentors, develops, leads and deploys hardworking Information Systems professionals to implement innovative and effective information systems solutions.
  • Ensures that systems are implemented and maintained in compliance with 21 CFR Part 11 and follows the IS Project Management Lifecycle Methodology.
  • Develops and maintains inspection readiness programs for multiple Regulatory agencies, as well as be main point of contact for presentations during inspections.
  • Management and organization of third-party organizations such as contractors, engineering firms and consultants, as well as internal, multi-functional area resources.
  • Coordination of business process and system issues across multiple departments, multiple functions and multiple locations.
  • Financial management including; budget planning, budget management, and business case development. Develop short/long term strategies, goals, objectives, and associated budgets required to ensure appropriate IS and site execution.
  • Lead the Information Systems Operational Excellence program and its execution.
  • Sets energizing performance expectations and provides timely feedback.
  • Delivers strong results consistent with compliance requirements and Amgen values.
  • Foster and maintain relationships with key site and network partners.


Basic Qualifications:

Doctorate degree and 2 years of Information Systems experience
OR
Master's degree and 6 years of Information Systems experience
OR
Bachelor's degree and 8 years of Information Systems experience
OR
Associate's degree and 10 years of Information Systems experience
OR
High school diploma / GED and 12 years of Information Systems experience
AND
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

Management/Leadership
  • Experience leading an organization direct line management experience for projects or departments.
  • Experience with teams that span globally or across multiple locations.
  • Experience in mentoring, motivating, leading and guiding information systems groups of business system analysts and other information technology professionals, responsible for support of multiple systems, applications and functional areas.
  • Ability to clearly quantify the business value of IS investments through fact-based models.
  • Proven experience and track record of compliance in a highly regulated Good Manufacturing Practices (GMP) environment.
  • Management and coordination of third-party organizations such as contractors, engineering firms and consultants.
  • Strong leadership experience and aptitude with demonstrated ability to effectively lead and partner in a sophisticated, matrix environment.


Technical
  • Operational Excellence mindset with diverse, and profound Continuous Improvement methodology experience (e.g., Lean, Six Sigma, Total Quality Management (TQM), etc.).
  • Diverse operations experience preferably in the manufacture of biologics with aseptic processing, drug substance and/or drug products focus.
  • Previous experience leading strategic planning efforts and the implementation of plans for coordinating multi-site enterprise-wide system solutions.
  • Experience implementing key performance metrics systems.
  • Demonstration of effective coordination of business process and system issues across multiple departments, multiple functions and multiple locations.
  • Proven adaptability, teamwork and decisiveness in a rapidly evolving/growing business environment.
  • Implementation experience of software and hardware components within an FDA regulated environment.
  • Experience with data aggregation and presentation (reporting, dashboards).


Competencies
  • Established Leadership capabilities
  • Passion for Operational Excellence
  • Financial acumen
  • Communications skills, both oral and written, including executive presentation skills
  • Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
  • Ability to tactfully negotiate and positively influence peers and executive leadership
  • Analytical skills to identify potential improvement opportunities


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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.



PI120804739
Posted: 2020-06-12 Expires: 2020-07-14

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Senior Manager & Site Lead Information Systems

Amgen
Woburn, MA 01801

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