QA Regulatory Lead – Pharma Submissions & Compliance

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

Benefits offered by this job

Bonus program

Benefits package

Tuition reimbursement

Job summary

Grifols inLos Angeles is seeking an experienced Quality Assurance Technical Manager to lead regulatory submissions and ensure compliant technical documentation. You will review validation protocols, collaborate across teams, and support inspections with precise responses.

The role requires a strong background in QA/regulatory affairs, cGMP/GLP knowledge, and excellent technical writing. Join Grifols and contribute to global healthcare leadership.

Qualifications

• Bachelor’s degree in sciences or related field.
• Minimum 5 years’ experience in QA, Regulatory Affairs, Compliance, QA Engineering or QC, with cGMP/GLP emphasis.
• Solid knowledge of FDA/EU/regulatory agency requirements.
• Ability to work independently with minimal supervision.
• Strong organizational, analytical and problem-solving skills.

Responsibilities

• Write, review and approve submissions to the FDA and other regulatory agencies.
• Review and approve validation IQ, OQ, PQ, CQ, FEQ, AMF and PV protocols/reports.
• Perform compliance reviews of Validation CAPAs and verify completeness and accuracy.
• Interface with groups to ensure accuracy of complex submissions for FDA and others.
• Participate in regulatory and internal inspections with written responses.
• Maintain current knowledge of FDA/EU and industry standards.
• Release approved regulatory changes in SAP for manufacturing.
• Review R&D stability and characterization protocols and final reports.
• Provide scientific/technical advice and edit SOPs, LSs, regulatory submissions.

Skills

Regulatory affairs

Quality Assurance

cGMP knowledge

GLP knowledge

Technical writing

Analytical skills

Interpersonal skills

MS Office proficiency

Education

Bachelor’s degree in sciences or related field

Tools

SAP

Job description

Grifols inLos Angeles is seeking an experienced Quality Assurance Technical Manager to lead regulatory submissions and ensure compliant technical documentation. You will review validation protocols, collaborate across teams, and support inspections with precise responses.

The role requires a strong background in QA/regulatory affairs, cGMP/GLP knowledge, and excellent technical writing. Join Grifols and contribute to global healthcare leadership.