Associate Director, Quality (Validation and 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

Description

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. 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.

Position Summary:

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.

Job Responsibilities:

The responsibilities for the Associate Director/Director, Quality, Validation and Data Integrity may include, but are not limited to the following activities:

• 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.

Qualifications:

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

Benefits:

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

Equal Opportunity Employment

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.