OPM Biosciences
OPM Biosciences is a rapidly expanding cell culture media and CDMO services provider with a strong global footprint. As the first cell‑culture media company publicly traded in China, OPM is now scaling its commercial presence in the United States, supporting biopharma, cell and gene therapy, vaccine, and biologics scientists with next‑generation CHO and HEK293 products & services.
About the role You’ll build and run the Quality System for our U.S. R&D and pilot operations—covering cell line development (CLD), cell culture process development, and small‑scale powder/liquid media production. You’ll own document control, deviations/CAPA, batch record review, supplier quality, and lot release, while getting the site “GMP-ready” as we scale.
What you’ll do Quality Management System (QMS)
Stand up and maintain a phase‑appropriate QMS (SOPs, forms, records) aligned with cGMP principles, ISO 9001/13485 good practices, and ICH Q9 risk management.
Own document control, training, change control, deviations/investigations, CAPA, and management review.
Implement data‑integrity by design (ALCOA+), including audit trails and controlled lab notebooks/eQMS.
CLD & Cell Culture Development QA oversight
QA oversight of cell banking (RCB/WCB): qualification, traceability, storage, chain‑of‑custody.
Ensure biosafety & compliance for BSL‑2 labs; oversee mycoplasma/sterility policies & materials control.
Review study plans, protocols/reports (DoE, comparability), and ensure reference standards control.
Approve deviations, investigations, and corrective actions tied to development studies.
Small‑Scale Media Production QA oversight
Establish batch record issuance, review, and lot release (spec, COA, label control).
Define in‑process/finished product specs (appearance, pH, osmolality, bioburden/endotoxin, clarity, assay).
Oversee equipment qualification (IQ/OQ/PQ), calibration, maintenance logs, and cleaning validation.
Set up environmental monitoring (ISO‑classified rooms as applicable) and gowning/behavioral controls.
QA support for sterile filtration (filter integrity), powder blending, mixing, packaging, and labeling.
Define material specifications and change‑notification requirements; maintain approved supplier list (ASL).
Audits, Compliance & Readiness
Lead internal audits; host client audits; coordinate responses/closure.
Build phase‑appropriate validation/qualification and change‑management strategies for GMP readiness.
Partner with EHS on biosafety/chemical compliance and waste management.
People, Training & Culture
Build a small but high‑performing QA team; coach R&D/Operations on quality best practices.
Own quality training curricula and effectiveness checks across functions.
Champion continuous improvement (Lean/6σ mindset) and right‑first‑time execution.
What you’ll bring
6+ years in Quality within biologics, cell culture, media, CDMO, or adjacent life‑sciences manufacturing; 2+ years in a QA lead/manager role.
Hands‑on experience with CLD/cell culture workflows and pilot‑scale media production (powder and/or liquid).
Strong command of cGMP principles, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+), and phase‑appropriate compliance for R&D → clinical scale‑up.
Proven track record standing up QMS elements (deviations/CAPA, change control, doc control, batch review, training).
Exposure to equipment/utilities qualification (e.g., cleanrooms, HVAC, PW/DI water, cold rooms), EM programs, and quality risk management.
Excellent cross‑functional communication; comfortable working with both scientists and operators.
Bachelor’s in life sciences or engineering required; advanced degree a plus.
Nice to have
Start‑up/CDMO experience; client‑audit hosting.
eQMS/LIMS experience; statistics for trending (e.g., control charts, process capability).
Familiarity with sterile filtration, endotoxin control, and cleaning validation for media operations.
Benefits
Competitive base salary + bonus.
Health, dental, vision; 401(k); paid time off.
We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
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About the role You’ll build and run the Quality System for our U.S. R&D and pilot operations—covering cell line development (CLD), cell culture process development, and small‑scale powder/liquid media production. You’ll own document control, deviations/CAPA, batch record review, supplier quality, and lot release, while getting the site “GMP-ready” as we scale.
What you’ll do Quality Management System (QMS)
Stand up and maintain a phase‑appropriate QMS (SOPs, forms, records) aligned with cGMP principles, ISO 9001/13485 good practices, and ICH Q9 risk management.
Own document control, training, change control, deviations/investigations, CAPA, and management review.
Implement data‑integrity by design (ALCOA+), including audit trails and controlled lab notebooks/eQMS.
CLD & Cell Culture Development QA oversight
QA oversight of cell banking (RCB/WCB): qualification, traceability, storage, chain‑of‑custody.
Ensure biosafety & compliance for BSL‑2 labs; oversee mycoplasma/sterility policies & materials control.
Review study plans, protocols/reports (DoE, comparability), and ensure reference standards control.
Approve deviations, investigations, and corrective actions tied to development studies.
Small‑Scale Media Production QA oversight
Establish batch record issuance, review, and lot release (spec, COA, label control).
Define in‑process/finished product specs (appearance, pH, osmolality, bioburden/endotoxin, clarity, assay).
Oversee equipment qualification (IQ/OQ/PQ), calibration, maintenance logs, and cleaning validation.
Set up environmental monitoring (ISO‑classified rooms as applicable) and gowning/behavioral controls.
QA support for sterile filtration (filter integrity), powder blending, mixing, packaging, and labeling.
Define material specifications and change‑notification requirements; maintain approved supplier list (ASL).
Audits, Compliance & Readiness
Lead internal audits; host client audits; coordinate responses/closure.
Build phase‑appropriate validation/qualification and change‑management strategies for GMP readiness.
Partner with EHS on biosafety/chemical compliance and waste management.
People, Training & Culture
Build a small but high‑performing QA team; coach R&D/Operations on quality best practices.
Own quality training curricula and effectiveness checks across functions.
Champion continuous improvement (Lean/6σ mindset) and right‑first‑time execution.
What you’ll bring
6+ years in Quality within biologics, cell culture, media, CDMO, or adjacent life‑sciences manufacturing; 2+ years in a QA lead/manager role.
Hands‑on experience with CLD/cell culture workflows and pilot‑scale media production (powder and/or liquid).
Strong command of cGMP principles, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+), and phase‑appropriate compliance for R&D → clinical scale‑up.
Proven track record standing up QMS elements (deviations/CAPA, change control, doc control, batch review, training).
Exposure to equipment/utilities qualification (e.g., cleanrooms, HVAC, PW/DI water, cold rooms), EM programs, and quality risk management.
Excellent cross‑functional communication; comfortable working with both scientists and operators.
Bachelor’s in life sciences or engineering required; advanced degree a plus.
Nice to have
Start‑up/CDMO experience; client‑audit hosting.
eQMS/LIMS experience; statistics for trending (e.g., control charts, process capability).
Familiarity with sterile filtration, endotoxin control, and cleaning validation for media operations.
Benefits
Competitive base salary + bonus.
Health, dental, vision; 401(k); paid time off.
We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
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