Reference # : 20-00728 Title : Quality Systems Manager Location : Gaithersburg, MD Position Type : Direct Placement Experience Level : Start Date : 09/02/2020 Description This position reports directly to the Associate Director, Quality Systems
R esponsibilitiesinclude but are notlimitedto:
Design, deployment and continuous improvement of Deviation, CAPA and Change Control Programs
Management and maintenance of Quality Systems to support product disposition of clinical trial and commercial materials
Create, track and present metrics related to the Deviation, CAPA and Change Control Programs for Senior Management
Participate in regulatory inspections and maintain a state of inspection readiness
Maintain working knowledge of Documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
Management of staff
Other duties as assigned
Mi n im u m Requirements:
Bachelor's degree in a scientific discipline
8+ years of Quality experience in pharmaceutical, biologics and/or vaccine manufacturing
Minimum of 2 years supervisory experience
Knowledge and expertise in principles and practices of current Good Manufacturing Practices (cGMP)
Demonstrated verbal and written skills in communicating regulatory and technical information
Solid organizational and time management skills, proven project management, presentation and facilitation skills
Preferred: Biotechnology experience preferred
Innovation including looking internally and externally for best practices
Preferred Requirements :
The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems
The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail
The ability to enable and drive change while being focused on internal and external customers
The ability to communicate well both verbally and in writing with all levels both inside and outside of the organization
Prior experience with qualified electronic solutions (deployment and maintenance)
Capable to manage multiple priorities
This positionmayrequire periodicweekend/eveningwork.
RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
RCM Technologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.
Posting ID: 571546490Posted: 2020-09-27