Sr. Manager, Facility Quality, Biologics Manufacturing
Full Time
San Francisco, CA
Posted
Job description
This is a stellar opportunity leading a broad set of Facility Quality Operations for large scale commercial biologics bulk manufacturing and fill/finish capabilities. This is a once-in-a-lifetime Expat leadership opportunity within the World?s Largest biologics CMO expanding from 362,000L to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody and mRNA vaccine manufacturing capabilities. You will be charged with overseeing the following activities:
Leading overall inspection readiness including regulatory inspections, client audits and due diligence.- Leading GMP document review and approval for change control, CAPA, deviations, SOPs and other GMP documents.
- Generating and executing validation protocols for facility and utilities validation activities including HVAC, WFI and Clean Steam.
- Providing Quality recommendations for facility maintenance and utilities operations.
- Leading Quality Assurance oversight of product release, batch record execution, batch record review, approval of production deviations, change controls, compliance, and investigations.
- Leading Quality Engineering operations including Validation, Technical Operations, Technical Troubleshooting, and CAPA.
- Overseeing Quality Risk Management activities.
- Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance.
- Hosting regulatory inspections, leading inspection readiness activities, and leading Pre-Approval Inspections (PAI) and serving as a facility tour escort during regulatory inspections, audits and virtual audits.
- Working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA.
8+ years Biopharmaceutical or Biotechnology industry experience.- BS, MS or Ph.D. in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biology, Chemistry or related Engineering or life sciences related field. MBA a plus.
- Experience hosting and leading global regulatory audits and regulatory inspections.
- Quality Operations leadership facilities, utilities (HVAC, WFI and Clean Steam) or plant maintenance related operations.
- Quality leadership experience working on bulk manufacturing of commercial biologics including monoclonal antibodies and recombinant protein therapeutics.
- Experience working in a Facility Operations, Facility Maintenance or Facility Quality Operations position.
- Strong experience ensuring cGMP compliance and working directly with global regulatory agencies including the FDA, EMEA, MHRA, Health Canada, PMDA, and KFDA.
About the Company:
Expatriate Benefits Package:
Competitive base salary, target bonus, retirement allowance and excellent medical benefits.- Company paid luxury apartment in Songdo.
- International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools.
- Company paid airfares to visit the US (or country of origin).
- 3 weeks of vacation time.
- Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels
- Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University.
- Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport.
You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/
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