Director, Quality, Validation & Data Integrity

Larimar Therapeutics; Bala Cynwyd (PA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Incentive stock options

401K plan

Flexible PTO

Job summary

Larimar Therapeutics, a publicly held clinical-stage biotechnology company, seeks an Associate Director/Director, Quality, Validation and Data Integrity in Bala Cynwyd, PA to oversee GxP Computer Systems validation and the data integrity program.

The role requires a Bachelor’s degree in a scientific or technical discipline and 8+ years in biotech/pharma quality, with at least 3 years in GxP validation; strong knowledge of 21 CFR Part 11, EU Annex 11 and GAMP 5 is required.

Qualifications

• Bachelor’s degree in a scientific or technical discipline required.
• 8+ years in a Quality role in biotech/pharmaceutical industry.
• At least 3 years’ direct experience with GxP computer systems validation.

Responsibilities

• Provide Quality oversight of CSV/CSA activities for GxP systems.
• Manage data integrity program including CAPA actions and remediations.
• Review and approve validation documentation and change controls.
• Deliver training on validation and data integrity principles.

Skills

GxP validation

Data integrity

Regulatory compliance

Project collaboration

Training delivery

Education

Bachelor’s degree in scientific or technical discipline

Tools

URS/FS review

GxP systems

Job description

Larimar Therapeutics, a publicly held clinical-stage biotechnology company, seeks an Associate Director/Director, Quality, Validation and Data Integrity in Bala Cynwyd, PA to oversee GxP Computer Systems validation and the data integrity program.

The role requires a Bachelor’s degree in a scientific or technical discipline and 8+ years in biotech/pharma quality, with at least 3 years in GxP validation; strong knowledge of 21 CFR Part 11, EU Annex 11 and GAMP 5 is required.