Sr. Manager/Associate Director, Quality, (Validation And Data Integrity)

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Description

The Company:

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), 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 assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

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 to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position:

Sr. Manager/Associate Director, Quality, (Validation and Data Integrity)

Reports to: Senior Director, Quality

Position Summary:

The Sr. Manager/Associate Director, Quality, Validation and Data Integrity will be responsible to provide quality support and oversight for Larimar's validation activities and to manage the 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 Sr. Manager/Associate 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.

• Author and/or 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 revise 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.

Requirements

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 a minimum 6 years of experience in a Quality role in the biotechnology/pharmaceutical industry with at least 2 years' experience with 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. The successful candidate will possess a strong attention to detail while having the ability to set priorities and meet aggressive timelines.

Benefits:

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

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 relationship with all candidates and 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 or childbirth), 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.