Amgen Sr. Manager Labeling in Thousand Oaks, California

Amgen is Seeking a Labeling Performance Senior Manager to work out of their Thousand Oaks, CA location.

The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents and the USPI to provide quality product labels and drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.

The Labeling Performance Sr Manager reporting into the Head of Global Labeling, will direct and oversee End to End (E2E) global labelling process, governance and metrics to enhance compliance and continuously improve performance of the E2E global labeling process. This position will establish and deliver a Global Quality Management system for labelling across all Amgen products and markets where Amgen products are solid, set a framework for and provide strategic leadership on global labeling process improvement initiatives. This position is responsible for providing strategic guidance & periodic updates to senior management on the health of the E2E process, including data and insights for quarterly updates to the CEO.

Specific responsibilities of the Senior Manager include:

  • Accountable for the overall process and health of the end to end labeling process through a robust QMS and suite of performance metrics and dashboard

  • Accountable for cross functional labeling processes, policies, SOP's and controlled documents

  • Accountable for reporting on global compliance of the timely implementation of all label changes

  • Thought leader on industry best practices

  • Leading larger or more complex global labeling projects

  • Accountable for the Global Labeling Budget

  • Accountable to establish and lead global labeling governance to enhance compliance and to continuously improve performance of the end to end labeling process including Labeling Management Review

  • Is the Secretary of the ELB, establish and implement operating rules, agendas, tools and tracking of labeling governance bodies.

  • Analyze, resolve and escalate issues to senior leadership

  • Ownership of global end to end process and labeling systems (LEXA)

  • Accountable for the suite of labeling performance metrics/KPIs that ensure business excellence and global compliance

  • Accountable to track and report the health of end to end global labeling change implementation across all Amgen products through routine monitoring, investigation & issue management (includes deviations / waivers)

  • Member of the Global Labeling leadership team

  • Lead and collaborate with cross functional labeling partners to drive process excellence and develop / implement improvement initiatives

  • Provide monthly update of compliance status, highlighting any failed KCIs or risks to head of labeling & head of GPS&L

  • Leads E2E BPOs to resolve E2E Labeling process issues

  • Accountable for hiring, succession planning & resource management / workload distribution

  • MAP documentation and personal development plans (self and direct reports)

  • Set and oversee labeling performance budget

Basic Qualifications:

Doctorate degree and 2 years of Pharmaceutical/Biotech and/or labeling experience

OR Master's degree and 6 years of Pharmaceutical/Biotech and/or labeling experience

OR Bachelor's degree and 8 years of Pharmaceutical/Biotech and/or labeling experience

OR Associate's degree and 10 years of Pharmaceutical/Biotech and/or labeling experience

OR High school diploma / GED and 12 years of Pharmaceutical/Biotech and/or labeling 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:

  • Previous experience working in industry in support of Global Labelling, Regulatory, Quality Management/Quality Engineering

  • Advanced knowledge of labeling regulations with particular focus on the regulatory environment in global markets.

  • Accomplish business results through teams/ability to influence without direct authority

  • Proficiency in anticipating and resolving problems

  • Understanding the impact of emerging regulatory requirements and their implications for Amgen

  • Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect

  • Excellent people, time and project leadership/management skills

  • Ability to take initiative and drive results

  • Proficiency in anticipating and resolving problems

  • Oral and written communication and presentation skills

  • Influencing, negotiation and decision-making skills

  • People and financial management

  • Previous experience in leadership and management of people, process and systems

  • Previous experience in labeling

  • Demonstrates leadership attributes

  • Excellent interpersonal skills

  • External visibility (e.g., through industry committees)

  • Manage individual and complex group projects

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.