24 days old

Regional Operations Manager - JAPAC

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114880125
Amgen

Job ID: R-81638
Location: Thousand Oaks, CA, US 91360

As Amgen expands globally, this is a key position in implementing the Japan/Asia Pacific Region's (JAPAC) strategy and product launch plans. This role will include collaboration cross-functionally to establish new supply routes, supply sites, distribution models, setting up systems, managing variations, and overall launch coordination.

Responsibilities:
  • Serve as the Operations champion for JAPAC Commercialization of assigned product(s)
  • Lead Regional Operations Team Meetings to manage launch and product life-cycle deliverables
  • Lead cross functional meetings that support the Regional communication plan
  • Represent the region/country on PDT; attend PST meetings; participate in Joint venture and partnership management activities for assigned products
  • Regularly and clearly communicate region's decision, risks, and project timeline to the PDT and appropriate Operations management/governance
  • Generate project charters and ensure project gate reviews are in alignment with international commercialization process; manage within regional budget requirements
  • Participate in Operational Excellence opportunities and drive regional improvements and cost savings by leveraging Network Knowledge sharing forums
  • Develop regional network supply strategy with Global Supply Chain and Sites
  • Own undisrupted patient supply, supply risk assessment and mitigation plans for assigned products
  • Support Demand and Supply Alignment activities for assigned product/market
  • Represent the supply network and work with region's cross functional team (Commercial, Finance, Regulatory Affairs, Quality) to develop compliant product supply strategy for the planning horizon
  • Represent the region commercial needs and work with supply network to resolve supply conflicts
  • Own cross functional alignment and setup of Physical and Financial Flows for product and country
  • Execute Operations Commercialization Strategy through regional strategy development and management; ensure regional adherence to CMC Excellence
  • Own product launch CCMS records and ERP systems setup (such as the creation of sales org, material # and customer #); partner with regional planner to ensure timely setup
  • Contribute to preparation and review of supply agreements and regulatory documentation as needed
  • Lead Regional variation management review process to determine supply strategy for assigned products
  • Ensure country regulations and requirements are clear and incorporated into the global process
  • Ensure compliant execution to meet local regulatory, trade, and quality regulations
  • Some international and domestic travel possible but expected less than 15%.


Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of operations experience

OR

Bachelor's degree and 4 years of operations experience

OR

Associate's degree and 10 years of operations experience

OR

High school diploma / GED and 12 years of operations experience

Preferred Qualifications:

  • Master's Degree in Business, Supply Chain, or Engineering
  • APICS or equivalent certification
  • 3+ years of experience in Pharmaceutical product commercialization, life cycle management, Planning,
  • Regulatory Affairs, Clinical Development and/or international supply chain operations
  • Understanding of marketing principles and competitor practices
  • Experience in project management across departments and geographies
  • Ability to recognize strategic implications of complex product development activities and manage them cross-functionally
  • Quick process understanding, insight and visualizing
  • Fluent in English oral and written; Proficiency in local JAPAC language a benefit
  • Strong analytical skills (incl. MS Excel, MS PowePpoint) and ability to summarize findings
  • Independent self-starter, able to work autonomously, under pressure and in teams
  • Relationship builder in which employer's interests prevail: be soft on the relationship when possible and be tough when needed
  • Motivated, persistent, eager to optimize, drive for excellence
  • Problem solver with high sense of responsibility to achieve results
  • Strong communication and presentation skills (verbal & written)
  • GMP knowledge and understanding of pharmaceutical regulations


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.

PI114880125

<b>Amgen</b><br/><br/><b>Job ID: </b>R-81638<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>As Amgen expands globally, this is a key position in implementing the Japan/Asia Pacific Region's (JAPAC) strategy and product launch plans. This role will include collaboration cross-functionally to establish new supply routes, supply sites, distribution models, setting up systems, managing variations, and overall launch coordination.<br><br>Responsibilities:<br><ul><li>Serve as the Operations champion for JAPAC Commercialization of assigned product(s)</li><li>Lead Regional Operations Team Meetings to manage launch and product life-cycle deliverables</li><li>Lead cross functional meetings that support the Regional communication plan</li><li>Represent the region/country on PDT; attend PST meetings; participate in Joint venture and partnership management activities for assigned products</li><li>Regularly and clearly communicate region's decision, risks, and project timeline to the PDT and appropriate Operations management/governance</li><li>Generate project charters and ensure project gate reviews are in alignment with international commercialization process; manage within regional budget requirements</li><li>Participate in Operational Excellence opportunities and drive regional improvements and cost savings by leveraging Network Knowledge sharing forums</li><li>Develop regional network supply strategy with Global Supply Chain and Sites</li><li>Own undisrupted patient supply, supply risk assessment and mitigation plans for assigned products</li><li>Support Demand and Supply Alignment activities for assigned product/market</li><li>Represent the supply network and work with region's cross functional team (Commercial, Finance, Regulatory Affairs, Quality) to develop compliant product supply strategy for the planning horizon</li><li>Represent the region commercial needs and work with supply network to resolve supply conflicts</li><li>Own cross functional alignment and setup of Physical and Financial Flows for product and country</li><li>Execute Operations Commercialization Strategy through regional strategy development and management; ensure regional adherence to CMC Excellence</li><li>Own product launch CCMS records and ERP systems setup (such as the creation of sales org, material # and customer #); partner with regional planner to ensure timely setup</li><li>Contribute to preparation and review of supply agreements and regulatory documentation as needed</li><li>Lead Regional variation management review process to determine supply strategy for assigned products</li><li>Ensure country regulations and requirements are clear and incorporated into the global process</li><li>Ensure compliant execution to meet local regulatory, trade, and quality regulations</li><li>Some international and domestic travel possible but expected less than 15%.</li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 2 years of operations experience<br><br>OR<br><br>Bachelor's degree and 4 years of operations experience<br><br>OR<br><br>Associate's degree and 10 years of operations experience<br><br>OR<br><br>High school diploma / GED and 12 years of operations experience<br><br>Preferred Qualifications:<br><br><ul><li>Master's Degree in Business, Supply Chain, or Engineering</li><li>APICS or equivalent certification</li><li>3+ years of experience in Pharmaceutical product commercialization, life cycle management, Planning,</li><li>Regulatory Affairs, Clinical Development and/or international supply chain operations</li><li>Understanding of marketing principles and competitor practices</li><li>Experience in project management across departments and geographies</li><li>Ability to recognize strategic implications of complex product development activities and manage them cross-functionally</li><li>Quick process understanding, insight and visualizing</li><li>Fluent in English oral and written; Proficiency in local JAPAC language a benefit</li><li>Strong analytical skills (incl. MS Excel, MS PowePpoint) and ability to summarize findings</li><li>Independent self-starter, able to work autonomously, under pressure and in teams</li><li>Relationship builder in which employer's interests prevail: be soft on the relationship when possible and be tough when needed</li><li>Motivated, persistent, eager to optimize, drive for excellence</li><li>Problem solver with high sense of responsibility to achieve results</li><li>Strong communication and presentation skills (verbal & written)</li><li>GMP knowledge and understanding of pharmaceutical regulations</li></ul><br> <br> Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/5DaNPxu4Egk7f8O6CpWBQ"> <p>PI114880125</p>

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Posted: 2019-10-25 Expires: 2019-11-25

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Regional Operations Manager - JAPAC

Amgen
Thousand Oaks, CA 91360

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