Senior Manager, Clinical Quality

Larimar Therapeutics, Inc.; Philadelphia (Philadelphia County); Sur place; USD 140 000 - 190 000; Plein temps

Avantages offerts par ce poste

Incentive stock options

401K

Flexible PTO policy

Résumé du poste

Larimar Therapeutics Inc. seeks a Senior Manager, Clinical Quality to lead study-level quality for a clinical-stage biotech, partnering across operations to ensure trial integrity.

You will drive GCP quality risk management, audits, deviations, CAPAs, inspections readiness, and fit-for-purpose quality systems for global studies.

Qualifications

• Bachelor’s degree in life sciences or related discipline with 6+ years in a regulated biotech quality role.
• Minimum 2 years GCP audits of investigator sites and/or CROs (GxP audit experience).
• Knowledge of GxP systems, risk-based quality management, and GCP guidelines (FDA, EMA, MHRA).
• Experience supporting global clinical trials in biotech, pharma, or CRO settings.
• Self-starter, detail-oriented, collaborative, and able to thrive in a fast-paced environment.
• Strong initiative and ownership while working with cross-functional teams.

Responsabilités

• Provide proactive quality oversight for Phase I-IV clinical studies globally, reviewing protocols, ICFs, study plans, and docs.
• Identify CtQ factors and KQI with study teams to develop risk assessments and risk registers.
• Lead investigations for deviations, noncompliance, quality events, and serious breaches.
• Facilitate root cause analysis and ensure CAPA development, implementation and verification.
• Lead investigator site audits, vendor audits, internal process audits, and for-cause audits as needed.
• Evaluate audit findings, assess compliance risk, escalate significant observations and trends.
• Oversee CROs, labs, and vendors; perform vendor quality risk assessments for qualification.
• Quality reviews of deviations and CAPAs associated with CROs, labs, and vendors.
• Develop, revise, and implement quality and clinical processes and procedures.
• Support continuous improvement to enhance quality process efficiency and scalability.
• Support inspections and sponsor audits; coordinate responses and corrective actions.
• Facilitate lessons-learned assessments after inspections and quality events.
• Collect and analyze quality metrics to support management reviews.
• Support other quality activities as required.
• Approximately 10-15% travel required.

Connaissances

GCP audits

Quality assurance

Regulatory knowledge

Cross-functional collaboration

Formation

Bachelor’s degree in life sciences or related discipline

Description du poste

All Jobs > Senior Manager, Clinical Quality

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.

Job Responsibilities:

Position Overview:

The Senior Manager, Clinical Quality serves as the study-level quality leader for the clinical quality assurance program for a clinical-stage biotechnology company focused on developing innovative therapies for patients with rare diseases through novel cell-penetrating peptide technology. This highly visible, cross-functional role partners with Clinical Operations, TMF Management, Biostatistics, Data Management, Medical Affairs, and external service providers to ensure the quality and integrity of clinical trial activities throughout the product development lifecycle.

The Senior Manager is responsible for providing proactive quality oversight of ongoing and planned clinical studies; leading GCP quality risk management activities; managing audit programs; managing deviations, investigations, and CAPAs; supporting inspection readiness; and maintaining fit-for-purpose quality systems that comply with applicable global regulations and guidelines, including ICH GCP, FDA, EMA, MHRA, Health Canada, and other applicable regulatory requirements.

Key Responsibilities:

Will include but are not limited to:

• Provide proactive quality oversight for Phase I-IV clinical studies conducted globally, including reviewing study protocols, ICFs, study plans and other clinical trial specific documents
• Partner with study teams to identify Critical-to-Quality (CtQ) factors and Key Quality Indicators (KQI) to develop risk assessments and maintain quality risk registers.
• Lead investigations related to deviations, protocol noncompliance, quality events, and potential serious breaches.
• Facilitate root cause analysis and ensure timely development, implementation, and effectiveness verification of CAPAs.
• Lead investigator site audits, vendor audits, internal process audits, and for-cause audits, as needed
• Evaluate audit findings, assess compliance risk, and ensure timely escalation of significant observations or audit trends
• Provide quality oversight for CROs, laboratories, technology vendors, and other GxP service provider by completing vendor quality risk assessments to support vendor qualification activities.
• Performs quality reviews of deviations, investigations and CAPAs associated with CROs, laboratories, technology vendors and other vendors supporting clinical studies
• Lead development, revision, and implementation of quality and clinical processes and procedures
• Support continuous improvement projects that enhance efficiency, effectiveness, and scalability of quality processes.
• Support Health Authority inspections and sponsor audits by coordinating inspection response activities, documentation requests, and/or corrective action commitments.
• Facilitate lessons-learned assessments following inspections and significant quality events.
• Collect and generate quality metrics and trend analyses to support management reviews
• Support other Quality activities, as required.
• Approximately 10-15% travel required.

Requirements

This role requires a Bachelor’s degree in life sciences or related discipline with a minimum of 6+ years’ experience in a Quality role supporting Clinical Operations departments within a regulated biotechnology or pharmaceutical environment is required. A minimum of 2 years experience performing GCP audits of investigator sites and/or CROs or comparable GxP audit experience. Knowledge of GxP systems, risk-based quality management principles, and GCP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) is required. Experience supporting global clinical trials within biotechnology, pharmaceutical, or CRO settings is preferred. The successful candidate will be a self-starter with strong attention to detail, while also being a collaborative team player. They will thrive in a fast-paced environment, taking initiative and ownership while working effectively with others to achieve shared goals.

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.