Senior Quality Lead - Validation & Data Integrity

Larimar Therapeutics, Inc.; Pennsylvania; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Incentive stock options

401(k)

Flexible PTO

Job summary

Larimar Therapeutics, Inc. in Bala Cynwyd, PA, seeks an Associate Director/Director of Quality, Validation and Data Integrity to lead GxP computer systems validation and data integrity programs.

This role will require oversight of CSV/CSA activities and collaboration with IT and business teams. The position reports to the Senior Director of Quality and will oversee validation documentation, risk assessments, and training to ensure regulatory compliance and inspection readiness.

Qualifications

• Bachelor’s degree in a scientific or technical discipline with 8+ years in a biotech/pharma quality role.
• At least 3 years of direct experience with GxP computer systems validation.
• Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5 concepts and best practices.

Responsibilities

• Provide quality oversight of CSV/CSA activities for initial implementations, changes, maintenance and decommissioning of GxP systems.
• Run risk assessment, planning, and mitigation to keep computerized systems in a qualified state.
• Review and approve validation documentation (URS, FRS, CS, DS, IOQ, PQ/UAT, etc.).
• Improve processes for GxP systems compliance in collaboration with IT and business.
• Participate in project teams to approve validation documentation and change controls.
• Manage the data integrity program and deliver data integrity assessments and CAPAs.
• Deliver training on validation and data integrity principles.
• Create and review SOPs and work instructions supporting validation and data integrity.
• Participate in vendor audits/assessments and internal audits as SME on GxP computerized systems.
• Support GxP health authority inspections as SME for computerized systems and data integrity.
• Support other quality activities as required.

Skills

Quality assurance

GxP validation

Regulatory knowledge

Education

Bachelor’s degree in a scientific or technical discipline

Job description

Larimar Therapeutics, Inc. in Bala Cynwyd, PA, seeks an Associate Director/Director of Quality, Validation and Data Integrity to lead GxP computer systems validation and data integrity programs.

This role will require oversight of CSV/CSA activities and collaboration with IT and business teams. The position reports to the Senior Director of Quality and will oversee validation documentation, risk assessments, and training to ensure regulatory compliance and inspection readiness.