Regulatory QA Manager – FDA Submissions & Compliance

Grifols, S.A; Los Angeles (CA); On-site; USD 95,000 - 119,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

PTO

Paid holidays

401(K) match

Job summary

Grifols is seeking a Quality Assurance Technical Manager in California to lead FDA submissions and coordinate technical documentation to meet timelines. You will review validation protocols and ensure cGMP/GLP compliance across the QA function.

The role requires 5+ years in QA/regulatory fields, strong technical writing, and ability to work independently with cross-functional teams; SAP experience is a plus. Excellent organizational and communication skills are essential.

Qualifications

• Bachelor’s degree in the sciences or related field.
• Minimum 5 years’ experience in Quality Assurance, Regulatory Affairs, Compliance, Quality Engineering or Quality Control in the pharmaceutical/biotech industry with emphasis on cGMP/GLP.
• Comprehensive knowledge of cGMPs, FDA/EU requirements, and industry guidelines.
• Ability to work independently with minimal supervision.
• Strong organizational, analytical, and problem-solving skills with structured decision-making.
• Self-starter with strong work ethic and good judgment.
• Excellent technical writing and interpersonal skills; strong communication.
• Proficiency in MS Office.

Responsibilities

• Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation required to meet submission timelines.
• Review and approve validation IQ, OQ, PQ, CQ, FEQ, AMF and PV protocols and reports.
• Perform compliance reviews of Validation CAPAs ensuring action items are addressed and information is complete.
• Interface with various groups to ensure content in complex regulatory submissions is accurate and complete.
• Participate in regulatory and internal inspections/audits and respond to auditors as needed.
• Maintain current knowledge of FDA, EU and other regulatory agencies and industry standards.
• Release approved regulatory changes in SAP for manufacturing implementation.
• Review and approve R&D stability and characterization protocols and final reports.

Skills

Quality Assurance

Regulatory Affairs

Compliance

Quality Engineering

Quality Control

Education

Bachelor's degree in sciences

Tools

SAP

MS Office

Job description

Grifols is seeking a Quality Assurance Technical Manager in California to lead FDA submissions and coordinate technical documentation to meet timelines. You will review validation protocols and ensure cGMP/GLP compliance across the QA function.

The role requires 5+ years in QA/regulatory fields, strong technical writing, and ability to work independently with cross-functional teams; SAP experience is a plus. Excellent organizational and communication skills are essential.