Senior Manager, Clinical Quality Assurance at Summit

Develop and manage companys quality management system (processes and
procedures) to ensure regulatory compliance to established quality policies
and applicable US GCP regulations that are required to support US new drug
development activities. Primary responsibilities include management of drug
development SOP systems and procedures, archiving of QA records, conducting
local GCP audits, contribution to global GCP audits, assistance in FDA
audits, follow-up and management of CAPA, and facilitation of GCP/QA
training program.

ESSENTIAL DUTIES & RESPONSIBILITIES

(Include but not limited to the following. Other duties may be assigned.)

*       Responsible for the development, implementation, and maintenance of
companys quality management system, including:

-Manage the GCP documentation, SOP processes and procedures, and CAPA
systems.

-Manage the review and tracking of established SOPs.

-Actively participate in the review of departmental SOPs to ensure GCP
compliance.

-Monitor and advise on regulatory compliance of quality documentation
system.

*       Lead and/or contribute to GCP audits of studies and systems of
affiliate companies and vendors in the US as well as in Europe and Asian
countries.

*       Assist in FDA audits/field inspection activities.

*       Serve as knowledge resource with regards to US GCP requirements to
support new drug development activities.

*       Develop quality and compliance awareness across affiliate companies.

*       Provide QA consultancy to project teams, and as requested, to
affiliates.

*       Facilitate communication among affiliate QA units.

*       Establish and maintain GCP/QA training program for company personnel
involved in new drug development activities.

*       Perform periodic quality system documentation review with regards to
ongoing quality improvement.

QUALIFICATIONS

*       In-depth knowledge of GCP, FDA regulations, quality systems, and
Quality Assurance
*       Membership of relevant professional body and professional
qualifications preferred
*       Prepared to take initiatives without constant supervision
*       Well developed diplomatic and communication skills
*       Able to balance the objectivity required for compliance assessment
with the teamwork skills required to win cooperation across disciplinary
boundaries
*       Proactive approach to problem solving

EDUCATION and/or EXPERIENCE

*       BS/BA degree in a life science discipline or equivalent and directly
related work experience
*       Minimum of 5 years experience in GCP Quality Assurance
*       Biotechnology/biologics experience preferred
*       Experience with controlled documents, change control and CAPA
systems
Country: USA, State: New Jersey, City: Summit, Company: Scientific Search.