Head of Clinical QA/GCP
Position Head of Clinical QA/GCP
Company resTORbio, Inc.
Location Boston, MA
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.
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