Senior Manager/Associate Director of Quality Assurance
Position Sr. Manager/Associate Director of Quality Assurance
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.
Implement the Quality Management System to ensure regulations are adhered to and industry best practices are followed.
Independently initiate and manage the generation, review, and approval of SOP’s in compliance with applicable regulatory requirements.
Lead batch record review, product disposition / release, change control, investigations into deviations, and execution of CAPAs.
Provide guidance pertaining to current GMPs and apply updates to Quality System.
Support GxP training of functional areas and contributes to the development of appropriate training for internal and external personnel.
Oversee execution of external audit program: review audit reports and track corrective/preventive actions in accordance with applicable regulations, guidelines and SOPs.
Manage the internal audit programs.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
Bachelor’s degree with minimal 7-10 years of professional experience in the Biotech or Pharma industries including at least 5 years in quality assurance & regulatory compliance.
Possess in-depth knowledge of GMP regulations, principles, concepts, industry practices and standards. GLP and GCP experience a plus.
Ability to contribute to the Quality Assurance function to support global drug development candidates from pre-clinical to commercial.
Understanding of domestic and international regulatory requirements.
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
Demonstrated ability to translate a practical strategy into action.
Outstanding communication skills (interpersonal, verbal and written).
Strong leadership and management skills.
Excellent teamwork and collaboration skills.
Ability to travel as required for audits.
TO APPLY PLEASE CONTACT HR AT resTORbio