Associate Director, Quality (Validation and Data Integrity)

About the Company

This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein, to the mitochondria of patients with Friedreich’s ataxia—a rare, progressive, and fatal disease caused by insufficient FXN production due to a genetic abnormality.

The company has 80 employees and an experienced management team, each with over 20 years of pharmaceutical industry experience. The team possesses significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and GMP manufacturing processes. The company’s strategy is to become a leader in rare disease treatment by leveraging its technology platform and team’s know-how to advance CTI-1601 and future pipeline programs. It is characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

About the Role

The Associate Director/Director, Quality, Validation and Data Integrity will provide quality support and oversight for Larimar’s GxP Computer Systems and manage the Data Integrity program, ensuring compliance with relevant regulatory requirements and industry standards. This position reports to the Senior Director, Quality and is based in the office located in Bala Cynwyd, PA. The number of required in-office days is currently flexible and may change over time.

Responsibilities

• Provide Quality oversight of Computer System Validation (CSV)/Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems.
• Execute and manage risk assessment, planning, and execution/mitigation activities to ensure computerized systems supporting GxP operations remain in a qualified state throughout their lifecycles.
• Review and approve relevant validation documentation, including but not limited to: URS, FRS, CS, DS, IOQ, PQ/UAT, VP, VSR, and RA.
• Streamline and improve processes for GxP systems compliance in collaboration with IT and the business.
• Participate in project teams to provide guidance and approval of project Validation documentation and relevant Change Controls.
• Manage the data integrity program, including timelines for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations).
• Deliver training on validation and data integrity principles/requirements to foster employee awareness and accountability.
• Create, review, and approve Policies, SOPs, and Work Instructions supporting validation and data integrity activities.
• Participate in vendor audits/assessments, qualification activities, or internal audits involving GxP computerized systems as a Subject Matter Expert (SME).
• Support GxP health authority inspections by serving as SME for computerized system and data integrity topics.
• Support other Quality activities, as required.

Requirements

• Bachelor’s degree in a scientific or technical discipline.
• 8+ years of experience in a Quality role in the biotechnology/pharmaceutical industry, with at least 3 years’ direct experience in GxP computer systems validation.
• Experience with GxP validation methodology.
• Strong understanding of 21 CFR Part 11, EU Annex 11 regulations, GAMP 5 concepts, applications, and best practices.
• Strong attention to detail with the ability to work independently and collaboratively in a fast-paced environment.
• Demonstrated ability to initiate process improvements, set priorities, and meet aggressive timelines.

Benefits

• Incentive stock options.
• Comprehensive benefits plan including 401K.
• Flexible PTO policy.