Director of Medical Staff Office Hca Healthcare
San Jose, CAToday
Highlights
As the QA Manager, 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. 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.
Numbers & Facts
| Location | Pleasanton, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Job Description:
- As the QA Manager, 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.
Key Responsibilities
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.
Supplier & Materials Quality
- Qualify raw-material suppliers (audits/questionnaires), set incoming inspection plans, manage SCARs.
- 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/6 mindset) and right-first-time execution.
Qualifications
- 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.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
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