Quality Systems Director — Pharma Compliance & QMS

SHARP STERILE MANUFACTURING LLC; Lee (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

SHARP STERILE MANUFACTURING LLC in Lee, MA is seeking a Director of Quality Systems to lead the QA Quality Systems division, ensuring cGMP compliance and regulatory alignment for pharmaceutical and biotech activities. The role involves overseeing document control, training, complaints, supplier management, and quality agreements.

The candidate will drive inspections readiness, lead CAPAs, and report quality metrics to senior management, with a focus on continuous process improvement and

Qualifications

• Minimum of ten (10) years of pharmaceutical experience in a quality role.
• Minimum of five (5) years in a supervisor/managerial role.
• Thorough knowledge of FDA/EU regulations related to quality systems.

Responsibilities

• Lead the Quality Systems division within QA to support clinical and commercial activities.
• Oversee Document Control, Training Programs, Complaint Handling, Supplier Management, and QMS.
• Manage the Complaint Program with root cause analysis and CAPAs.
• Oversee Vendor Approval Program with audits and qualifications.
• Develop Quality Agreements with clients and critical suppliers.
• Lead Client Change Notification and Client Audit programs.
• Support regulatory inspections and respond to agency requests.
• Prepare quality metrics reports for senior leadership.
• Provide support for ANDA/NDA submissions and inspections.
• Perform Annual Product Reviews and monitor compliance with evolving regulations.

Skills

QA leadership

cGMP compliance

Regulatory knowledge

Documentation control

Training & programs

Root cause analysis

Quality metrics

Effective communication

Education

Bachelor of Science Degree

Master’s Degree preferred

Auditor certification preferred

Job description

SHARP STERILE MANUFACTURING LLC in Lee, MA is seeking a Director of Quality Systems to lead the QA Quality Systems division, ensuring cGMP compliance and regulatory alignment for pharmaceutical and biotech activities. The role involves overseeing document control, training, complaints, supplier management, and quality agreements.

The candidate will drive inspections readiness, lead CAPAs, and report quality metrics to senior management, with a focus on continuous process improvement and