QA Manager — GMP Compliance & Audits Leader

Open Scientific; Deer Park (NY); On-site; USD 70,000 - 80,000; Full time

Job summary

Open Scientific is seeking an experienced QA Manager to oversee quality systems for a label manufacturer serving clinical trials and investigational drug products. The ideal candidate will have at least 5 years of management experience in the pharmaceutical/nutraceutical/food industry and hands-on GMP compliance.

This role includes writing and approving SOPs, leading a 22-person quality team, coordinating customer audits, calibration programs, validation (IQ/OQ/PQ), and maintenance of MSDS and

Qualifications

• Minimum 5 years of management experience in pharma/nutraceutical/food industries.

Responsibilities

• Oversee all quality systems for the label manufacturer of clinical trials and investigational drug products.
• Manage a staff of 22 including 3 managers and 2 supervisors.
• Develop, write, revise and approve all SOPs.
• Lead customer audits and respond to audit findings.
• Implement calibration programs, mock recalls, AQL sampling plans, line clearance methods.

Skills

QA Management

SOP Development

Audits & Compliance

GMP Knowledge

Tools

IQ/OQ/PQ Validation

Job description

Open Scientific is seeking an experienced QA Manager to oversee quality systems for a label manufacturer serving clinical trials and investigational drug products. The ideal candidate will have at least 5 years of management experience in the pharmaceutical/nutraceutical/food industry and hands-on GMP compliance.

This role includes writing and approving SOPs, leading a 22-person quality team, coordinating customer audits, calibration programs, validation (IQ/OQ/PQ), and maintenance of MSDS and