Quality Systems Specialist / Senior Specialist

Description

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:

Job Title: Quality Systems Specialist / Sr. Specialist 

Reports to: Associate Director, Quality Systems and Training

Position Summary:

The Quality Systems Specialist / Sr. Specialist has responsibility for supporting Larimar’s Quality Management System (QMS), Document Control and Training Programs. This role will interact with all Larimar departments to ensure GxP controlled documents are developed, implemented, and periodically evaluated and training assignments are appropriate and completed within the allotted timeframe. The Quality Systems Specialist / Sr. Specialist reports to the Associate Director, Quality Systems and Training.

This role will require being in the office in Bala Cynwyd, PA. At the current time, the number of days in the office is flexible and may change over time.

The responsibilities for the Quality Systems Specialist / Sr. Specialist may include, but are not limited to the following activities:

• Coordinate and support new employee onboarding training, including SOP training and introductory overview/navigation of the Larimar electronic Quality Management System (QMS).
• Coordinate and support the overall training program, including training associated with controlled document creations, revisions, annual GxP training, and other ad hoc training by acting as a training administrator in Larimar’s electronic Quality Management System.
• Support the creation and/or revision of Larimar training matrices, as needed.
• Support the development of training quizzes in Larimar’s electronic Quality Management System associated with SOPs and Work Instructions, as required.
• Contribute to the creation and/or revision of SOPs and Work Instructions supporting Document Control, Training, and the use and administration of the electronic QMS.
• Provide Document Control support across all departments at Larimar, including identification of gaps in existing SOPs, processing of document revisions, and the creation of new GxP documents. 
• Oversee the controlled GxP document periodic review process, ensuring that periodic reviews are completed adequately and within the allotted timeframe.
• Maintain quality system documentation to ensure compliance with applicable regulations and company requirements.
• Support the implementation of an electronic Quality Management System, as required.
• Act as a business administrator in Larimar’s electronic Quality Management System.
• Provide oversight and maintenance of Larimar’s electronic Quality Management System.
• Support the creation and/or modification of reports and dashboards in the electronic Quality Management System to support business and end-user needs.
• Support the reporting of metrics associated with the Document Control and Training programs, as required.
• Support other Quality activities, as required.

Requirements

Qualifications:

Title and compensation will be dependent on years of experience and qualifications. This role requires a bachelor’s degree and a minimum of 3 years of experience in a Quality role in the biotechnology/pharmaceutical industry. An understanding of GxP systems and quality principles, including the ability to understand and interpret global regulations and guidance documents (FDA, EMA, ICH) is also required. The successful candidate will possess a strong attention to detail while having the ability to set priorities and meet aggressive timelines. Strong experience with electronic Quality Management Systems and Microsoft Suite (e.g., Excel, Word, Teams) is required.

Preferred Qualifications:

• Experience with DocuSign, Egnyte, and Veeva QualityDocs and Vault Training modules is highly desirable.
• Must have strong written and oral communication and organizational skills.
• Demonstrated process improvement experience.
• Must be able to work individually and as part of a cross-functional team.

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.