Sr. Manager Quality Assurance – Aseptic Processes Validation
Juncos, Region Metropolitana, PR
hace 19 horas


If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission to serve patients drives all that we do.

It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.

It’s time for a career you can be proud of. Join us.

Sr. Manager Quality Assurance Aseptic Processes Validation

What you will do

Let’s do this. Let’s change the world! In this vital role you will lead the Quality Operations for AML14 supporting aseptic operations.

The Sr Mgr QA will provide oversight to the Aseptic Processes Validation Life Cycle, ensuring staff is well trained and execution in compliance with procedures and regulations.

Actively engaged with projects and deviations impacting the aseptic aspects on the formulation and filling operation areas to ensure requirements are complete and in compliance to current regulations.

Accountable for the Quality and Compliance state of the Aseptic Processes in a NON-STANDARD SHIFT Operations.

AML14 Operations consists of multiple suites encompassing component preparation, formulation and 3 filling lines, working 7 days a week.

Area is very dynamic, with a high number of production lots, investigations and projects, required in an expedited timeline.

Specifics responsibilities include but are not limited to :

  • Lead the Aseptic Validation Team, which encompasses the Environmental Monitoring Qualification, Airflow Visualization Studies and Aseptic Process Simulation.
  • Support for Major Deviations, CAPAs, CAPA EVs as Quality contact and all associated documents which include GMP document revision, and Quality System records with role of Quality contact or assessor.
  • Support the true Root Cause are identified and appropriate corrective actions are implemented.
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Supports Continual Improvement initiatives, programs and projects
  • Ensures that changes that could potentially impact product quality from the aseptic control are assessed according to procedures.
  • Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.
  • Ensures that Aseptic Validation personnel are qualified and trained to perform assigned functions in accordance with cGMP with requirements.
  • Ensures the Aseptic Validation Plans are implemented, maintained and reviewed in accordance with cGMP regulations.
  • Alerts senior management of significant quality, compliance, supply and safety risks.
  • Develops area goals, productivity, projects, and tracks progress.
  • Develops area budget and handles expenditures.
  • Works effectively with diverse departmental groups.
  • What we expect of you

    We are all different, yet we all use our unique contributions to serve patients! The Sr. Manager QA we seek is a collaborative strong leader with these qualifications.

    Doctor degree and 2 years of Quality or Manufacturing support experience in GMP regulated environment.

    Master’s degree and 6 years of Quality or Manufacturing support experience in GMP regulated environment.

    Bachelor’s degree and 8 years of Quality or Manufacturing support experience in GMP regulated environment.

    2 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.
  • Demonstrated ability to manage validation scientists and support others areas with skills in risk management.
  • Experience working with Aseptic Validations processes, including environmental qualification, air visualization studies and media fills.
  • Ability to delegate wisely and effectively.
  • Excellent team development and leadership skills.
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, Quality Control, validation, and process development.
  • Commands respect from team, peers, and management.
  • Detailed knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply.
  • Experience making quality decisions independently.
  • Excellent communication (both written and verbal), facilitation, and presentation skills in English and Spanish.
  • Demonstrate the Amgen Values / Leadership Practices.
  • Ability to lead changes in a high demand environment and adapt to changes in priorities.
  • Thrive

    What you can expect of us

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

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work / life balance, and career benefits
  • 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.


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