Senior Manager, Clinical Quality

Larimar Therapeutics•Philadelphia, PA

73d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in life sciences or related discipline
Minimum of 6+ years’ experience in a Quality role supporting Clinical Operations departments within a regulated biotechnology or pharmaceutical environment
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.
Self-starter with strong attention to detail
Collaborative team player
Thrive in a fast-paced environment, taking initiative and ownership while working effectively with others to achieve shared goals.

Nice To Haves

Experience supporting global clinical trials within biotechnology, pharmaceutical, or CRO settings is preferred.

Responsibilities

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 providers 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.