Director, QA Operations - Strategic GMP Leader

Genezen; Lexington (MA); On-site; USD 170,000 - 240,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan

Healthcare plans

FSA/HSA programs

Life insurance

Disability insurance

Job summary

Genezen in Lexington, MA, seeks a Director/Sr. Director of Quality Assurance Operations to oversee the QMS and ensure cGMP compliance across facilities, manufacturing, QC labs, and the supply chain.

Ideal candidate has 10+ years of GMP experience, a Bachelor’s or Master’s in Life Sciences or Engineering, and a proven ability to lead, drive CAPA, audits, and regulatory readiness while liaising with senior management.

Qualifications

• 10+ years of GMP experience in pharma/biotech quality roles (description)
• Experience in a cGMP manufacturing environment
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines
• Strong written and verbal communication with cross-functional teams
• Ability to work with minimal supervision

Responsibilities

• Develop, implement, and improve Quality Management Systems to ensure global regulatory compliance
• Provide guidance on phase-appropriate cGMP requirements
• Manage investigations and CAPA
• Review and disposition raw materials, intermediates, drug substance, and drug product
• Support Manufacturing, MSAT, FEV, Quality Control, and Supply Chain with QA
• Develop and report Quality System Metrics and risks to senior management
• Support internal and external audit programs
• Host and support inspections by health authorities
• Assess impact of new/regulatory changes on QMS and operations
• Maintain strong QA relationships with clients

Skills

Quality Assurance

GMP

cGMP manufacturing

Regulatory compliance

Quality systems

Documentation

Cross-functional collaboration

Education

Bachelor’s or Master’s Degree in Life Sciences or Engineering

Tools

MS Office

Job description

Genezen in Lexington, MA, seeks a Director/Sr. Director of Quality Assurance Operations to oversee the QMS and ensure cGMP compliance across facilities, manufacturing, QC labs, and the supply chain.

Ideal candidate has 10+ years of GMP experience, a Bachelor’s or Master’s in Life Sciences or Engineering, and a proven ability to lead, drive CAPA, audits, and regulatory readiness while liaising with senior management.