Associate Director of Quality – External Suppliers

Socket.dev; Gaithersburg (MD); On-site; USD 130,000 - 194,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid vacation and holidays

Job summary

Socket.dev in the United States is seeking an Associate Director Quality to lead quality management for external suppliers across Formulation, Fill, Finish & Packing. You will oversee supplier quality systems, conduct assessments, and partner with regulatory agencies to ensure GMP compliance.

This role requires a Bachelor's in a science/technical field and 10 years in a related role, with strong knowledge of cGMP, quality systems, and cross-functional collaboration. Travel up to 25% is expected.

Qualifications

• Bachelor or higher in a science/technical field with pharma exposure.
• Deep knowledge of cGMPs, quality systems, and the pharmaceutical supply chain.
• Excellent written and spoken English; ability to interact with regulators.

Responsibilities

• Oversee Quality Supplier Management including annual assessments and quality agreements.
• Review and approve cGMP documentation and validation plans with suppliers.
• Lead cross-functional quality improvements and regulatory inspection readiness.
• Escalate and resolve supplier quality issues to ensure on-time product supply.

Skills

Quality Management

Regulatory Compliance

GMP Knowledge

Project Management

Cross-functional Collaboration

Communication Skills

Problem Solving

Negotiation

Travel up to 25%

Education

Bachelor's degree in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering

Master's Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field

Job description

Socket.dev in the United States is seeking an Associate Director Quality to lead quality management for external suppliers across Formulation, Fill, Finish & Packing. You will oversee supplier quality systems, conduct assessments, and partner with regulatory agencies to ensure GMP compliance.

This role requires a Bachelor's in a science/technical field and 10 years in a related role, with strong knowledge of cGMP, quality systems, and cross-functional collaboration. Travel up to 25% is expected.