Quality Compliance Manager

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Boston, USA
Posting date: 05 Sep 2019

Proclinical is currently recruiting for a Quality Compliance Manager for a CRO company located in Boston, MA. Successful candidate will maintain the Quality Management System (QMS) and provide quality and compliance oversight. The QA Manager is responsible for maintaining and enhancing the Clinical Technology Quality Management System that promotes customer satisfaction and positively impacts performance of the company.

Job Responsibilities:

  • Manage, coordinate, and/or support sponsors' quality, privacy, security and 21 CFR Part 11 assessments.
  • Manage, coordinate, and/or support internal audits and client audits.
  • Coordinate and maintain company Quality Management System (QMS).
  • Manage and/or maintain company-wide quality and validation documents templates.
  • Manage and support QMS training.
  • Build strong relationships with internal and external clients, provide strategic support and drive client satisfaction with the quality management and quality oversight.
  • Provide quality and compliance oversight for critical business projects.
  • Maintain and/or support company-wide Corrective and Preventive Actions (CAPA) program.
  • Consult project teams on quality management and validation deliverables.
  • Facilitate quality-related internal project team meetings and calls.
  • Support project teams during quality related sponsor meetings and calls.

Skills and Requirements:

  • Bachelors Degree
  • Graduate Degree and/or professional certifications preferred.
  • 8+ years' quality, computer systems/software validation, management and project management experience.
  • 6+ years of quality management and/or validation leadership position.
  • Strong PC skills (i.e. Microsoft Office).
  • Proven organizational and project management skills.
  • Superior interpersonal communication and presentation skills.
  • Strong interpersonal and communication skills (both written and verbal).
  • Prior experience working with quality management systems in regulated environment of pharma and medical device companies.
  • Prior experience with and knowledge of clinical trials preferred.
  • Ability to evaluate and identify gaps in a QMS.
  • Knowledge and experience with Computer System Regulations (e.g. 21CFR Part 11) and GxP.
  • Knowledge of and experience with Agile SDLC and system validation and/or evaluating Computer Systems.
  • Ability to work in a global team environment and excellent global team-based problem solving skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan (+1) 347-293-1123 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.