Senior Manager, QA and Document Control
Position Senior Manager, QA and Document Control
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.
ROLE: SENIOR MANAGER, QA AND DOCUMENT CONTROL
resTORbio is currently growing its Quality Assurance team and is searching for a Sr. Manager/ Associate Director of Quality Assurance. This individual will be responsible for developing the Quality Management System and managing vendor audits. This position reports to the Vice President, Regulatory Affairs.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- Build the Quality Management System to ensure regulations are adhered to and industry best practices are followed.
- Independently initiates and manages the generation, review and approval of SOPs in compliance with applicable regulatory requirements. Leads batch record review, product disposition / release, change control, investigations into deviations and execution of CAPAs.
- Provides guidance pertaining to current GMPs, GCPs and GLPs and apply updates to the Quality System.
- Supports GxP training of functional areas and contributes to the development of appropriate training for internal and external personnel.
- Leads and manages quality with external vendor partners. Devises GxP audit schedule, oversees execution of audit plans and audits, reviews audit reports, and tracks corrective/preventive actions associated with key sites and contract service providers in accordance with applicable regulations, guidelines and SOPs.
- Manages the internal audit programs.
- Manages contractors/consultants
- Ability to grow out the Quality Assurance function to support drug development candidates from pre-clinical to commercial.
- Possess in-depth knowledge of GMP regulations, principles, concepts, industry practices and standards. GLP and GCP experience a plus.
- 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.
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.
An attractive compensation package commensurate with this senior leadership role will be provided.
HIRING EXECUTIVE PROFILE
Vice President of Regulatory Affairs
Karen Jauregui brings to resTORbio more than 20 years of global drug development experience including regulatory affairs, clinical operations, quality assurance and project management. She has worked in many therapeutic areas including anemia, imaging, CNS, GI and osteoarthritis, as well as with pediatric and orphan indications. She has extensive experience interacting and negotiating with Regulatory Authorities including FDA, EMA and PMDA. Most recently Karen served as Vice President of Regulatory Strategy at Akebia Therapeutics where she was responsible for global regulatory strategy and planning of early and late stage compounds. Previously, Karen served as Director of Global Regulatory Affairs at EMD Serono providing regulatory oversight to developmentprograms in various therapeutic areas. She also served in multiple roles of increasing responsibility at Repligen Corporation including Senior Director of Clinical Operations and Regulatory Affairs. Karen received her B.S. in Biology and Medical Technology from the State University of New York at Plattsburgh.
TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE
Senior Director, Quality Assurance
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Physician Recruitment – (Support)
220 Gibraltar Road, Ste 150
Horsham, PA 19044