Director, Quality & Data Integrity (CSV/CSA)

Larimar Therapeutics; Philadelphia (Philadelphia County); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Incentive stock options

401K

Flexible PTO

Job summary

Larimar Therapeutics, based in Philadelphia, PA, seeks an Associate Director/Director, Quality, Validation and Data Integrity. You will provide QA oversight for GxP computer systems and manage the data integrity program, ensuring regulatory compliance across validation activities.

The role reports to the Senior Director, Quality and requires 8+ years in biotech/pharma quality with solid GxP validation experience. On-site in Bala Cynwyd, PA with flexible in-office days.

Qualifications

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

Responsibilities

• Provide QA oversight of CSV/CSA activities for GxP systems across lifecycle.
• Lead risk assessment, planning, and validation activities for computerized systems.
• Review and approve validation documentation (URS, FRS, DS, IOQ, PQ/UAT, etc.).
• Streamline processes for GxP systems compliance with IT and business teams.
• Lead/participate in project validation documentation and Change Controls.
• Manage Larimar’s data integrity program and related CAPA actions.
• Deliver training on validation and data integrity principles to staff.
• Create/review Policies, SOPs, and Work Instructions for validation and data integrity.
• Participate in vendor audits/assessments as SME and support inspections.

Skills

GxP Computer Systems

CSV/CSA

21 CFR Part 11

Regulatory Compliance

Education

Bachelor's degree in science or technical field

Tools

GAMP 5

Job description

Larimar Therapeutics, based in Philadelphia, PA, seeks an Associate Director/Director, Quality, Validation and Data Integrity. You will provide QA oversight for GxP computer systems and manage the data integrity program, ensuring regulatory compliance across validation activities.

The role reports to the Senior Director, Quality and requires 8+ years in biotech/pharma quality with solid GxP validation experience. On-site in Bala Cynwyd, PA with flexible in-office days.