Director Quality Assurance
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Posted on:
22 hours ago
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1 Vacancy
Job Summary
Career Category
QualityJob Description
Director Quality Assurance
Amgen Singapore Manufacturing Singapore
HOW MIGHT YOU DEFY IMAGINATION
Amgen is one of the worlds leading independent biotechnology companies. For over 4 decades Amgen has pioneered biotechnology breakthroughs to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Director Quality Assurance in Amgen Singapore Manufacturing.
Live
What you will do
Main Responsibilities:
- Quality Professional with extensive background and experience in commercial production of Biologics and traditional GMP active pharmaceutical ingredient (API) drug substances.
- Provide Quality leadership and oversight to plant operations ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System through phases of facility design commissioning process qualification regulatory approval and market supply to establish a Quality culture for routine operations.
- Oversee Quality Assurance support for all ASM manufacturing activities (including on-the-floor quality oversight batch record review quality records approval) IS PD F&E QC Validation and Supply Chain GMP activities (including on-the-floor quality oversight Incoming Quality Data Integrity Assessments Periodic Reviews PLC Delta V Enterprise Systems)
- Supervise in New Product Introduction (NPI) team to ensure robustness of product changeover as well as cross contamination controls are in place.
- Oversee site inspection management participate in regulatory inspections and interact directly with regulatory inspectors.
- Act as delegate to Quality Assurance Executive Director when required to support business needs.
All listed tasks and responsibilities are deemed as essential functions to this position; however business conditions may require reasonable accommodations for additional tasks and responsibilities.
Win
What we expect of you
Basic Qualifications
- Doctorate degree in Chemistry Chemical Engineering Science or related technological field and 4 years of directly related experience OR
- Masters degree in Chemistry Chemical Engineering Science or related technological field and 8 years of directly related experience OR
- Bachelors degree in Chemistry Chemical Engineering Science or related technological field and/or 10 years of directly related experience
Preferred Qualifications
- Preferred 12 years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry
- Experience with leading teams conducting batch record review raw material and product release
- Experience in pharmaceutical equipment operation design and control
- Experience in leading teams providing floor support troubleshooting unit operations and resolving and documenting investigations to support cGMP production
- Experience in leadership roles with facility commissioning and validation strategy development and execution
- Strong communication skills (technical writing and verbal communication/presentation)
- Work in and lead teams effectively with variety of communication and working styles
- Ability to independently conduct budget workforce planning and staff management and development
- Demonstrated skills in the following areas:
- Lead and manage projects
- Commissioning and Qualification
- Scheduling and budget
- Collaboration
- Facility Licensing Regulatory audits and inspections
- Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
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.
Equal Opportunity Statement
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 a 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 an accommodation.
.Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
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 ... View more
