Sr. Manager/Associate Director of Quality Assurance

resTORbio logo Final.jpg

Senior Manager/Associate Director of Quality Assurance


POSITION DESCRIPTION

Position           Sr. Manager/Associate Director of Quality Assurance
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

  • 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.

  • Manage contractors/consultants.


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

hr@restorbio.com