15 days old

Director Deviations, Risk Management & Inspection Readiness

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    119095865
Amgen

Job ID: R-96301
Location: Juncos, PR, US 00777

Come and Grow with us!

Are you ready to demonstrate your strategic leadership skills? We are looking for creative, highly motivated and strategically Director Drug Substance Deviations, Risk Management and Inspection Readiness professional to be part of the world's leader bio-pharmaceutical company with a versatile portfolio of products!

Our science-based approach has led to the discovery of novel therapies in the areas of cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Our patient-centered culture fuels our commitment to delight their experience with innovative medicine delivery systems. Located in Juncos, Puerto Rico, AML is Amgen's largest multi-product end-to-end manufacturing site where most of the combination products portfolio move through our 1.7 million square foot biotechnology facility.

This role will lead a team of compliance-focused, technical investigators responsible for ownership of major deviations and associated CAPA actions to prevent re-occurrence, execution of risk management activities, ensuring inspectional readiness across AML6 and AML7 drug substance manufacturing. Also, will be interacting directly with the Executive Leadership Team forum and closely work & collaborate with Amgen's manufacturing network to ensure innovation is incorporated into our processes and ensure to meet the expected results.

The departments

The AML-6 and AML-7 facilities are the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facilities highlight the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian & bacterial Drug Substance manufacturing facilities in the world.

Specific responsibilities include but are not limited to:

  • Responsible for effective and timely closure of all major manufacturing investigations involving cross-functional teams and ensuring robust CAPAs are implemented for AML6 and AML7, analyze investigations, assemble investigation teams, manage deviation workflow, root cause analysis (including advanced root cause analysis such as kepner-Tregoe), harmonize content and writing style and ensure applicability of actions at plant, site, and network levels is raised appropriately. Benchmark lead continuous improvement initiatives to enhance deviation/CAPA management for the business unit delivering efficient, risk-based and fit-for-purpose processes.
  • Identify key areas of highest risk across the business to create and oversee execution of inspection readiness and risk mitigation efforts, including Quality Risk Assessment Technical Reports, with direct visibility to senior leadership at the site and network level as applicable
  • Build and maintain a high-performing team, collaborate internally with cross-functional teams within Drug Substance facilities at the site, and with network peers, as well as externally with suppliers.
  • Champion the quality culture standards, leadership attributes, critical thinking skills and high reliability mindset in the team and peers. Develop and cultivate a higher-level quality compliance and problem-solving, predict and prevent mindset in the team and partner functions throughout the AML drug substance manufacturing network.
  • Ensure connectivity with the scientific and technical basis for our processes, systems and equipment, as well as the criticality of understanding the details of the execution and systems in place on the production floor.


The leader will provide key oversight for:
  • Develop training and ongoing short-term and long-term plans for staff working with major deviations, aligned with quality sciences and compliance, the manufacturing network and global business process owner including proper tools and ongoing coaching of performance against expectations for investigation proficiency.
  • Execution of critical inspection readiness activities including creating standards for successful inspection preparation and execution. Embed real-time collaboration for risk evaluation and scoping, inspection readiness materials development building stronger partnering with quality compliance and quality sciences throughout the investigation process (quality compliance 365).
  • Coach and mentor staff that will be communicating information to regulatory inspectors
  • Manage global health authority inspection preparation activities and provide leadership and oversight during inspections. Promote increased visibility to Amgen network and industry observations, near-misses and trends - ensure applicability actions are completed for the AML drug substance network and serve as a role model for information sharing and collaboration on improvement opportunities within the Amgen drug substance network.
  • Facilitate ongoing quality improvements by owning CAPA records and risk mitigation activities. Relentlessly drive robust effectiveness feedback/checks, prevention of event recurrence and consistent, reliable, efficient processes from the start and throughout their lifecycle across the AML drug substance manufacturing network.
  • Serves as main liaison between deviation team and QA organization for ongoing investigations, CAPAs, risk management, compliance


For this opportunity the basic qualifications are:

Doctorate degree and 4 years of experience in aPharmaceutical, Medical Device and/or Biotechnology industry.

Or

Master's degree and 8 years of experience in aPharmaceutical, Medical Device and/or Biotechnology industry.

Or

Bachelor's degree and 10 years of experience in aPharmaceutical, Medical Device and/or Biotechnology industry.

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Beyond that, additional preferred qualifications are:

  • Educational background in Life Sciences and/or Engineering
  • Strong technical knowledge and experience in drug substance manufacturing and processes
  • Extensive experience in directly managing and developing a technical organization
  • Organized approach skills to scoping and problem solving
  • Experience managing highly regulated organization
  • Proven problem solving and root cause analysis experience
  • Ability to change organizational culture around productivity and reliability
  • Strong continuous improvement mindset
  • Critical thinking, inquisitive with end to end mentality
  • Strong compliance, Quality, and regulatory knowledge
  • Strong communication and collaborative cross-functionally
  • Experienced in risk management and training strategy
  • Strong report writing and presentation skills
  • Excellent communications skills (verbal and written)
  • Proficient in English verbal and writing communication skills


The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

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 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 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

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.

PI119095865

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96301<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/><b>Come and Grow with us!</b><br><br>Are you ready to demonstrate your strategic leadership skills? We are looking for creative, highly motivated and strategically <b>D</b><b>irector Drug Substance Deviations, Risk Management and Inspection Readiness </b>professional to be part of the world's leader bio-pharmaceutical company with a versatile portfolio of products!<br><br>Our science-based approach has led to the discovery of novel therapies in the areas of cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Our patient-centered culture fuels our commitment to delight their experience with innovative medicine delivery systems. Located in Juncos, Puerto Rico, AML is Amgen's largest multi-product end-to-end manufacturing site where most of the combination products portfolio move through our 1.7 million square foot biotechnology facility.<br><br>This role will lead a team of compliance-focused, technical investigators responsible for ownership of major deviations and associated CAPA actions to prevent re-occurrence, execution of risk management activities, ensuring inspectional readiness across AML6 and AML7 drug substance manufacturing. Also, will be interacting directly with the Executive Leadership Team forum and closely work & collaborate with Amgen's manufacturing network to ensure innovation is incorporated into our processes and ensure to meet the expected results.<br><br><b>The departments</b><br><br>The AML-6 and AML-7 facilities are the home of best-in-class, multi-product Drug Substance Manufacturing Operations. The facilities highlight the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian & bacterial Drug Substance manufacturing facilities in the world.<br><br><b>Specific responsibilities include but are not limited to:</b><br><br><ul><li>Responsible for effective and timely closure of all major manufacturing investigations involving cross-functional teams and ensuring robust CAPAs are implemented for AML6 and AML7, analyze investigations, assemble investigation teams, manage deviation workflow, root cause analysis (including advanced root cause analysis such as kepner-Tregoe), harmonize content and writing style and ensure applicability of actions at plant, site, and network levels is raised appropriately. Benchmark lead continuous improvement initiatives to enhance deviation/CAPA management for the business unit delivering efficient, risk-based and fit-for-purpose processes.</li><li>Identify key areas of highest risk across the business to create and oversee execution of inspection readiness and risk mitigation efforts, including Quality Risk Assessment Technical Reports, with direct visibility to senior leadership at the site and network level as applicable</li><li>Build and maintain a high-performing team, collaborate internally with cross-functional teams within Drug Substance facilities at the site, and with network peers, as well as externally with suppliers.</li><li>Champion the quality culture standards, leadership attributes, critical thinking skills and high reliability mindset in the team and peers. Develop and cultivate a higher-level quality compliance and problem-solving, predict and prevent mindset in the team and partner functions throughout the AML drug substance manufacturing network.</li><li>Ensure connectivity with the scientific and technical basis for our processes, systems and equipment, as well as the criticality of understanding the details of the execution and systems in place on the production floor.</li></ul><br><br><b>The leader will provide key oversight for:</b><br><ul><li>Develop training and ongoing short-term and long-term plans for staff working with major deviations, aligned with quality sciences and compliance, the manufacturing network and global business process owner including proper tools and ongoing coaching of performance against expectations for investigation proficiency.</li><li>Execution of critical inspection readiness activities including creating standards for successful inspection preparation and execution. Embed real-time collaboration for risk evaluation and scoping, inspection readiness materials development building stronger partnering with quality compliance and quality sciences throughout the investigation process (quality compliance 365).</li><li>Coach and mentor staff that will be communicating information to regulatory inspectors</li><li>Manage global health authority inspection preparation activities and provide leadership and oversight during inspections. Promote increased visibility to Amgen network and industry observations, near-misses and trends - ensure applicability actions are completed for the AML drug substance network and serve as a role model for information sharing and collaboration on improvement opportunities within the Amgen drug substance network.</li><li>Facilitate ongoing quality improvements by owning CAPA records and risk mitigation activities. Relentlessly drive robust effectiveness feedback/checks, prevention of event recurrence and consistent, reliable, efficient processes from the start and throughout their lifecycle across the AML drug substance manufacturing network.</li><li>Serves as main liaison between deviation team and QA organization for ongoing investigations, CAPAs, risk management, compliance</li></ul><br><br><b>For this opportunity the basic qualifications are:</b><br><br>Doctorate degree and 4 years of experience in aPharmaceutical, Medical Device and/or Biotechnology industry.<br><br>Or<br><br>Master's degree and 8 years of experience in aPharmaceutical, Medical Device and/or Biotechnology industry.<br><br>Or<br><br>Bachelor's degree and 10 years of experience in aPharmaceutical, Medical Device and/or Biotechnology industry.<br><br>And<br><br>4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources<br><br><b>Beyond that, additional preferred qualifications are:</b><br><br><ul><li>Educational background in Life Sciences and/or Engineering</li><li>Strong technical knowledge and experience in drug substance manufacturing and processes</li><li>Extensive experience in directly managing and developing a technical organization</li><li>Organized approach skills to scoping and problem solving</li><li>Experience managing highly regulated organization</li><li>Proven problem solving and root cause analysis experience</li><li>Ability to change organizational culture around productivity and reliability</li><li>Strong continuous improvement mindset</li><li>Critical thinking, inquisitive with end to end mentality</li><li>Strong compliance, Quality, and regulatory knowledge</li><li>Strong communication and collaborative cross-functionally</li><li>Experienced in risk management and training strategy</li><li>Strong report writing and presentation skills</li><li>Excellent communications skills (verbal and written)</li><li>Proficient in English verbal and writing communication skills</li></ul><br><br><b>The benefits</b><br><br>Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.<br><br>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.<br><br>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.<br><br>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.<br><br>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<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/DowaA7Tm5BNdcYwysqmY6"> <p>PI119095865</p>

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Posted: 2020-03-17 Expires: 2020-04-17

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Director Deviations, Risk Management & Inspection Readiness

Amgen
Juncos, Puerto Rico 00777

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