Senior Specialist Quality Compliance

2 months ago

Holly Springs, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Specialist Quality Compliance

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be part of the Regulatory Compliance function, the Senior Specialist of Inspection Lifecycle Management (ILM) will be involved in the preparation for, execution of and response to Regulatory Agency and Business Partner inspections at the Amgen North Carolina (ANC) site. Preparation includes cross-functional and cross-site collaboration along with a strong on site presence for assuring a perpetual state of inspection readiness for ANC. Execution of the inspections includes serving in roles with direct interaction with inspectors as well as serving in support rooms/functions as needed. The role also includes leading the generation of formal response commitments for the ANC site, cascading inspection outcome information across Amgen sites and functions, identifying improvement opportunities and tracking commitment and improvement actions to completion.

Being a part of the ILM team includes being responsible for establishing and maintaining best practice and effective inspection lifecycle processes from preparation/readiness through execution and inspection outcome processes, so they can be applied consistently across Amgen globally. The position will apply knowledge of current regulations, standards and guidelines, in addition to requirements of applicable Standard Operating Procedures (SOPs), in the support of inspections.

In addition, the position may entail serving as a Subject Matter Expert (SME) for GMP compliance topics in support of various aspects of the Quality Management System (QMS), supporting Amgen's self-inspection program as well as being responsible for fulfilling various regulatory requests and documentation related to ANC site inspection/certification status.

  • Collaborate with functional areas and across Amgen in preparation for inspections
  • Perform site inspection readiness efforts including strategy sessions and pressure tests
  • Participate in inspections that may require direct/indirect interaction with regulators
  • Lead response and improvement actions resulting from Regulatory Agency and/or Business Partner inspections
  • Lead maintenance and continuous improvement for at least one (1) inspection lifecycle process stage and support all others
  • Represent site and Regulatory Compliance function on global networks
  • Provide clients with guidance on regulatory compliance expectations and trends
  • Provide leadership toward resolving site and multi-site compliance risks
  • Provide support to Regulatory submission teams
  • Support self inspection (internal audits) program
  • Perform tasks and participate on project teams as assigned to complete site, departmental, team and goals of the company.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The quality compliance professional we seek is a leader with these qualifications.

    Basic Qualifications:

  • High school diploma / GED and 12 years of Quality Compliance experience OR
Associates degree and 10 years of Quality Compliance experience ORBachelors degree and 6 years of Quality Compliance experience ORMasters degree and 4 years of Quality Compliance experience ORDoctorate degree and 2 years of Quality Compliance experience

Preferred Qualifications:

Bachelors Degree in Life Sciences or EngineeringExperience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspectionsExperience in auditing and defending processes, procedures and decisions during Health Authority inspections7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and proven experience in compliance, data analysis, project management, and quality systemsExperience managing staff and/or leading cross-functional teams, projects and/or programsThorough understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operationsPrevious exposure to bulk drug and drug product manufacturing and quality assurance processesExperience with facility start upsDetailed solid understanding of EU and US Good Manufacturing Practices (cGMPs)Proficiency in ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively.Experience with process improvement projectsProficiency in navigating through ambiguity and provide a structured problem-solving approachTrack record of building or participating as a member of impactful teamsProficiency in coordinating and leading cross-functional project teams to deliver to expectations and on scheduleAbility to maintain remote working relationships with team mates at other Amgen sites in order to identify and align to standard methodologies

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com

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