16 days old

Sr Mgr QA - Deviations - Life Cycle Management Drug Product

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    122045803
Amgen

Job ID: R-102185
Location: Juncos, PR, US 00777

Are you looking for a meaningful new opportunity to test and growth your QUALITY skills? We have an immediate need for a SR MANAGER QUALITY ASSURANCE to join the Major Deviation Life Cycle Management team. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our Drug Product and Supporting Areas at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role:

The Sr Mgr QA role will lead the Quality staff supporting the Deviation Lifecycle Workstream supporting investigations for major deviations investigations and its associated CAPA and CAPA Effectiveness Verification records along with all the associated GMP documentation (procedures, testing results, risk assessments, etc). This position will focus in supporting AML Drug Product Operations consists of 3 plants, AML-1 Inspection & Packaging, AML 14-Formulation & Filling, and AML-23 Solid Dosage Facilities, as well as the Process Development and Supply Chain Operations. Sr Manager QA needs to have the ability to work under pressure, adapt to changes in priorities, and have negotiations skills to influence staff and peers to ensure deliverable and results are timely met.

Specific responsibilities include but are not limited to:

  • Responsible for Major Deviations, CAPAs, CAPA Effectiveness Verification as Quality contact and all associated documents which include GMP document revision, and Quality System records with role of Quality contact.
  • Ensures true Root Cause are identified and appropriate corrective actions are implemented.
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
  • Supports Continual Improvement initiatives, programs and projects
  • Ensures that changes that could potentially impact product quality are assessed according to procedures
  • Ensures that deviations from established procedures are investigated and detailed per procedures
  • Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
  • Ensures that Quality Assurance personnel are qualified and trained to perform assigned functions in accordance with cGMP with requirements
  • Ensures the Quality Management System is 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


Education/Experience:

Doctor degree and 2 years of Quality or Manufacturing experience in pharmaceutical, medical device or biotechnology industry

Or

Master's degree and 6 years of Quality or Manufacturing experience in pharmaceutical, medical device or biotechnology industry

Or

Bachelor's degree and 8 years of Quality or Manufacturing experience in pharmaceutical, medical device or biotechnology industry

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:

  • Educational background in Life Sciences or Engineering
  • Demonstrated ability to manage a group of direct reports
  • Experience working with Quality Systems, especially investigations and corrective actions
  • Experience managing Regulatory/Internal audits interactions
  • Experience managing a team of quality professionals
  • Ability to delegate wisely and effectively
  • Works effectively with diverse departmental groups
  • 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
  • Able to make sound, quality decisions independently
  • Excellent communication (both written and verbal), facilitation, and presentation skills in English and Spanish
  • Skilled in risk management
  • Demonstrate the Amgen Values/Leadership Practices


The benefits:

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

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 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 millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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 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 millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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 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 millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.



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Posted: 2020-07-30 Expires: 2020-08-30

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Sr Mgr QA - Deviations - Life Cycle Management Drug Product

Amgen
Juncos, Puerto Rico 00777

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