Catalyst is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases.  Our mission is to improve the lives of patients with rare and ultra-rare diseases.  At Catalyst, we utilize leading-edge science in search of therapies that will improve the lives of those who suffer from rare-diseases, often without any therapeutic options. We believe that no other field of medicine holds as much promise and makes such a significant impact on patents’ lives as the development of novel orphan drugs.

 Position Summary

The Manager of Quality Assurance will be responsible for managing the implementation and execution of the Catalyst’s Quality System at its Corporate Office. The candidate will be the primary Quality contact for all Quality System related matters and will have strong experience in GxPs, relevant FDA regulations as well as the ability to function independently.

 Principal Responsibilities

 The Manager of Quality Assurance will work to ensure the roll out and on-going compliance of Catalyst quality and compliance systems, and associated procedures and standards.  

  Implement and maintain a GxP compliant Quality Management System (QMS) by facilitating related tasks including, but not limited to:

-                Recall management

-                Customer Complaints

-                Deviations

-                Change Control

-                CAPA

-                Regulatory Authority Interaction under the direction of the COO

-                Audit Program

-                Training

-                Management Review

§        Monitor and partner with vendors to ensure that Catalyst products are manufactured, stored and distributed in compliance with GxP requirements.

§       Ensure that Quality Standard Operating Procedures (SOPs) are implemented in accordance with US (21 CFR 210 & 211) and other cGMP/GDP/PV guidelines as applicable.

§       Act as an internal auditing resource to review, assess and assist in the implementation of Quality Improvement/remediation plans as identified through internal GMP/GDP/PV audits.

§        Coordinate timely communications of CAPA plans to stakeholders, as applicable.

§       In collaboration with Senior Management, weigh and communicate quality and compliance risks as appropriate.

 Qualifications

10 years+ of hands-on Quality Assurance / Compliance and management experience in pharmaceutical / biotech industry.

§       Thorough knowledge of applicable FDA requirements pertaining to GxP compliance a must.

§       Although this position would not have direct oversight of pharmacovigilance (PV) activities, it would be responsible for ensuring that post market surveillance requirements are met by monitoring PV’s compliance via internal audits.

§       Strong leadership ability.

§       Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.

§       Exceptional communication and interpersonal skills.

§       Ability to influence senior management, peers and other colleagues without direct reporting lines.

§       Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.

§        Ability to multi-task and prioritize work.

§        Strong organizational ability.

§        Demonstrable computer skills

 Education

 Bachelor's Degree in life science or pharmacy required; advanced degree a plus

§        Professional certifications, such as Six sigma, ASQ CQA, etc., a plus