GMP Operational Quality Senior Manager

Boston, NH - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

REQUIREMENTS:

Bachelors degree
6 years of experience working with GMP requirements and support of GMP manufacturing
Strong team leadership skills
Strong experience successfully leading event investigations Root Cause Analysis (RCA) and CAPA
Strong experience with electronic document management systems (QDoccs Trackwise Veeva)
Experience authoring and enforcing Agreements between CMOs/Suppliers and the Company
Investigation and CAPA approval experience
Experience conducting GMP document review including procedures work instructions specifications methods protocols and method reports
Ability to work in a fast-paced environment
In-depth experience leading complex projects/teams Strong project management processes / tools to lead meetings assist with project planning and facilitate completion of tasks
Ability to independently lead cross-functional teams and represent the Quality unit
Ability to mentor and guide staff skilled at transferring technical knowledge and teaching quality management skills
Ability to communicate cross-functionally to a wide variety of audiences
Demonstrated ability to manage teams and to develop personnel
Demonstrated ability to evaluate quality matters and make complex decisions

REQUIREMENTS: Bachelors degree 6 years of experience working with GMP requirements and support of GMP manufacturing Strong team leadership skills Strong experience successfully leading event investigations Root Cause Analysis (RCA) and CAPA Strong experience with electronic document management syst...