Associate Director, Quality (Validation and Data Integrity)

Larimar Therapeutics•Lower Merion Township, PA

2d•Onsite

About The Position

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. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has 80 employees and has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs). The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. The Associate Director/Director, Quality, Validation and Data Integrity will be responsible to provide quality support and oversight for Larimar’s GxP Computer Systems and to manage Larimar’s Data Integrity program, ensuring compliance with relevant regulatory requirements and industry standards/best practices. This position reports to the Senior Director, Quality. This role will require being in the office located in Bala Cynwyd, PA. At the current time, the number of days in the office is flexible and may change over time.

Requirements

Bachelor’s degree in a scientific or technical discipline
8+ years of experience in a Quality role in the biotechnology/pharmaceutical industry
At least 3 years’ direct experience with 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
Ability to work independently and collaboratively in a fast-paced environment
Demonstrated ability to initiate process improvements, set priorities and meet aggressive timelines

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 used to support GxP operations are maintained 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, RA, TM.
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 the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations etc.).
Deliver training on validation and data integrity principles/requirements to foster employee awareness and accountability.
Create and/or review and approve Policies, SOPs and Work Instructions supporting validation and data integrity activities.
Participate in vendor audits/assessments and 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.