Head of Clinical QA/GCP

resTORbio logo Final.jpg

Head of Clinical QA/GCP


POSITION DESCRIPTION

Position           Head of Clinical QA/GCP
Company        resTORbio, Inc.
Location         Boston, MA
Website           https://www.restorbio.com/


COMPANY BACKGROUND

resTORbio, Inc. (NASDAQ: TORC, $482M mkt cap) is a clinical-stage biopharmaceutical company focused on helping people live healthier longer through the development and commercialization of novel therapeutics for the treatment of aging-related diseases. resTORbio’s lead program is targeting the selective inhibition of TORC1 - an evolutionary conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiac and neurologic systems. resTORbio program has demonstrated in several clinical trials, including a randomized, placebo-controlled trial, the potential to treat multiple diseases of aging for which there are no approved therapies. RTB101, resTORbio’s lead drug candidate is a selective, orally administered, TORC1 inhibitor currently being tested in a Phase 2b clinical trial as a first in-class immunotherapy for reducing the incidence of respiratory tract infections in the elderly by enhancing the function of the immune system. The company expects to develop RTB101 for additional aging-related indications such as heart failure or neurodegenerative diseases.


KEY RESPONSIBILITIES

  • Develop strategy and provide quality/compliance leadership across the pipeline.

  • Develop and implement clinical quality (GCP) systems.

  • Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.

  • Develop and successfully implement master auditing plans and inspection and compliance strategies governed by Good Clinical Practices (GCPs), Good Laboratory Practice (GLP) and applicable regulations and guidance.

  • Ensure a high level of quality and consistency across the studies and interact with various groups including CRO’s and investigator sites.

  • Accountable for the operational quality support for clinical trials worldwide. Conducts audits of external vendors, CROs, and clinical sites.

  • Provide guidance on investigations, root cause analysis of compliance issues, CAPAs, and deviations related to GCP. Provide the appropriate metrics for tracking overall reporting requirements.

  • Act as an advisor on compliance related matters and implement corrective and preventive actions, enable program team to be inspection ready and support a culture of sustainable compliance.

  • Lead inspection readiness effort.

  • Write SOPs and lead team training.

  • Review clinical trial documents including Trial Master Files (TMFs).

  • Oversee document control and implementation of electronic document management system.


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • At least Bachelor’s Degree in Science or related field.

  • 10+ years' experience in the biotech/pharma industry (or with a mixed medical device / pharma clinical quality background).

  • 5+ years' recent experience leading quality assurance for clinical research, including phase III and pre-approval inspection readiness with FDA and EMEA.

  • Strong knowledge of FDA and ICH E-6 for Good Clinical Practice (GCP), and 21CFR Part 11 with respect to clinical processes and systems.

  • Excellent attention to detail and diligence in fast-paced, deadline driven environment

  • Strong written and verbal skills.

  • Desire to learn and be a part of a fast-growing company/dynamic team.

  • Demonstrates initiative and be solution oriented.

  • Comfortable being both an individual contributor and team player.

  • Excitement about the vision of resTORbio.



TO APPLY PLEASE CONTACT HR AT resTORbio

hr@restorbio.com