Director of Quality Assurance and Regulatory Affairs Neo Labs Pharmaceutical Irvine, CA Job Details Full-time $110,000 - $150,000 a year 3 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Manufacturing facility experience Bachelor's degree Packaging Pharmacy Chemistry Full Job Description Quality Assurance Manager / Director Job Overview NeoLabs Pharma is seeking an experienced Quality Assurance Manager / Director to lead and maintain the Quality Management System (QMS) for our GMP pharmaceutical manufacturing facility supporting peptide API manufacturing, CDMO operations, lyophilization, and future aseptic fill-finish manufacturing. This individual will provide leadership in Quality Assurance, regulatory compliance, and quality systems while partnering closely with Manufacturing, Validation, Engineering, QC, and Regulatory Affairs to support facility startup, commercial operations, and continuous improvement. Responsibilities  Lead, maintain, and continuously improve the site's Quality Management System (QMS).  Develop, review, approve, and maintain SOPs, specifications, batch records, quality documentation, and training programs.  Review and approve manufacturing batch records, finished product testing, product release, and stability protocols and studies.  Oversee deviations, investigations, CAPAs, change controls, complaints, nonconformances, and risk assessments.  Lead supplier qualification, vendor audits, quality agreements, incoming material release, shipping and receiving quality oversight, and packaging/label verification.  Support process validation, equipment qualification, cleaning validation, computerized system validation (CSV), environmental monitoring, aseptic process simulation (APS/media fills), and data integrity programs.  Ensure compliance with cGMP requirements and maintain inspection readiness through routine internal audits and quality oversight.  Serve as the primary Quality liaison during FDA, customer, and regulatory inspections, including preparation, inspection management, FDA Form 483 responses, corrective action plans, and regulatory follow-up.  Responsible of Drug Master Files (DMFs), regulatory submissions, technical documentation, and quality support for customer projects.  Ensure compliance with data integrity, electronic records, access control, document control, training, and record retention requirements.  Work closely with Manufacturing, Validation, Engineering, QC, and Regulatory Affairs to support facility startup and commercial manufacturing operations.  Promote a culture of quality, compliance, continuous improvement, and operational excellence. Regulatory Knowledge Strong working knowledge of

FDA 21 CFR

Parts 210, 211, and 11, ICH Guidelines (Q7, Q8, Q9, Q10), USP requirements, EU Annex 1, Annex 11, Annex 15, current cGMP regulations, and pharmaceutical Quality Management Systems. Experience supporting FDA inspections and customer audits is highly preferred. Preferred Experience  10+ years of Quality Assurance experience in pharmaceutical, biotechnology, peptide API, sterile manufacturing, or CDMO environments.  Experience developing and maintaining Quality Management Systems (QMS).  Experience with validation, qualification, aseptic processing, investigations, CAPAs, change control, supplier qualification, batch record review, product release, and regulatory inspections.  Experience with Drug Master Files (DMFs), computerized system validation (CSV), stability programs, media fills (APS), and data integrity requirements.  Experience supporting startup facilities and CQV, brownfield projects, or GMP facility remediation is highly desirable.  Previous leadership or management experience preferred. Education Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline. Leadership Expectations The Quality Assurance Manager / Director will serve as the site's Quality leader and work collaboratively across all departments to establish and maintain a robust Quality Management System that supports regulatory compliance, operational excellence, successful facility startup, and commercial manufacturing. This individual will be responsible for ensuring the facility remains inspection-ready and operates in full compliance with FDA, cGMP, and applicable international regulatory requirements.

Pay:

$110,000.00 - $150,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person