QC Manager
Novartis
3 months ago
On-site
Carlsbad, CA
$114,000 - $211,900 USD yearly
Operations
Responsibilities:
- Manage QC Analytical activities aligned to site objectives; coordinate departmental operational activities and ensure QC team metrics (KQI/KPI) meet requirements.
- Perform incoming, in-process, and release testing; review laboratory data.
- Coordinate with internal/external partners for Quality Control; serve as technical expert.
- Initiate local hiring; lead OpEx projects.
- Investigate deviations/OoX/complaints; define and implement CAPAs.
- Support transfer projects and validation studies.
- Report and follow up HSE incidents.
- Support new equipment commissioning (OQ, PQ); plan resources/capacity and manage workload.
- Support leadership/performance of QC Analytical team; ensure availability of equipment, chemicals, and consumables.
- Review/revise SOPs; ensure training per cGxP; manage documentation/methods per cGxP; manage exceptions.
- Ensure DI and compliance with cGxP and regulatory requirements; lead GxP audits/inspection plan fulfillment.
- Review/release equipment qualification; ensure methods/procedures up to date; ensure calibration status.
- Review/approve microbiological testing.
Qualifications & Skills:
- Bachelor’s degree in Chemistry, Biology, or related field.
- 5+ years QC experience in pharma (preferably radiopharmaceuticals); 2+ years people manager experience.
- Experience managing a cGMP laboratory; knowledge of cGMP/GxP, EP/USP; FDA radiopharmaceutical regulations.
- Analytical methods/equipment knowledge: HPLC, iTLC, endotoxin, bioburden, pH, NVP, viable particle counters.
Work setup:
- Shift work with weekend requirements; on-site Carlsbad, CA (no relocation support).
Compensation & Benefits:
- Salary range: $114,000–$211,900/year; performance cash incentive; possible annual equity.
- Comprehensive benefits (health/life/disability, 401(k) with match) and time off.
Application instruction (accommodation):
- For reasonable accommodations, email [email protected] or call +1(877)395-2339 and include the job requisition number.
- Manage QC Analytical activities aligned to site objectives; coordinate departmental operational activities and ensure QC team metrics (KQI/KPI) meet requirements.
- Perform incoming, in-process, and release testing; review laboratory data.
- Coordinate with internal/external partners for Quality Control; serve as technical expert.
- Initiate local hiring; lead OpEx projects.
- Investigate deviations/OoX/complaints; define and implement CAPAs.
- Support transfer projects and validation studies.
- Report and follow up HSE incidents.
- Support new equipment commissioning (OQ, PQ); plan resources/capacity and manage workload.
- Support leadership/performance of QC Analytical team; ensure availability of equipment, chemicals, and consumables.
- Review/revise SOPs; ensure training per cGxP; manage documentation/methods per cGxP; manage exceptions.
- Ensure DI and compliance with cGxP and regulatory requirements; lead GxP audits/inspection plan fulfillment.
- Review/release equipment qualification; ensure methods/procedures up to date; ensure calibration status.
- Review/approve microbiological testing.
Qualifications & Skills:
- Bachelor’s degree in Chemistry, Biology, or related field.
- 5+ years QC experience in pharma (preferably radiopharmaceuticals); 2+ years people manager experience.
- Experience managing a cGMP laboratory; knowledge of cGMP/GxP, EP/USP; FDA radiopharmaceutical regulations.
- Analytical methods/equipment knowledge: HPLC, iTLC, endotoxin, bioburden, pH, NVP, viable particle counters.
Work setup:
- Shift work with weekend requirements; on-site Carlsbad, CA (no relocation support).
Compensation & Benefits:
- Salary range: $114,000–$211,900/year; performance cash incentive; possible annual equity.
- Comprehensive benefits (health/life/disability, 401(k) with match) and time off.
Application instruction (accommodation):
- For reasonable accommodations, email [email protected] or call +1(877)395-2339 and include the job requisition number.