Quality Assurance Manager


Full time

Framingham, MA

The Quality Assurance (QA) Manager is responsible for ensuring BERG’s Quality Management Systems are of the highest quality by maintaining and improving compliance to procedures, policies, and guidelines.

Responsibilities

Clinical Program Support

  • Manage the electronic Quality Management System (eQMS) (MasterControl)
  • Serve as a resident Quality expert in support of QMS activities (GLP, GCP, and CLIA)
  • Serve as the System administrator for eQMS system
  • Configure and implement Process and Auditing modules to expand usage of the system
  • Author and review departmental SOPs, as well as, review non-departmental SOPs
  • Provide day-to-day management of document control processes and workflows within the EDMS
  • Manage any regulatory or governing body certifications (CLIA)
  • Manage change control, CAPA, deviation, and investigation programs
  • Review and approve executed documents including validation documents, reports that could be filed in support of regulatory submissions, and operating procedures.
  • Oversee the internal and external audit program, which includes, focus on GxP, GLP, GCP, CLIA compliance, regulatory agency inspection readiness, and for-cause inspections
  • Provide support to Clinical Team and Laboratory to ensure compliance with GCP’s, GLPs and applicable regulatory requirements
  • Work with clinical operations and regulatory affairs to review submission documents.
  • Directly interface with Clinical Operations to provide support for vendor, site and internal GCP audits.
  • Perform and/or support audits of clinical sites, CROs and other clinical vendors.
  • Review and approve audits to ensure GCP compliance.
  • Assist in the development of Quality Agreements with GCP vendors.
  • Oversee and/or conduct CQA review of clinical protocols and reports.
  • Maintain relationships with vendors, contractors, and consultant to ensure effective execution of assigned tasks.
  • Facilitate vendor management
  • Build and manage department budget
  • Responsible for facilitation and maintenance training records
  • Responsible for records management and facilitation of off-site records storage.
  • Identify, develop, and communicate a metrics (KPI) system to drive awareness and improvement measurement
  • Other duties, as assigned.

Qualifications

  • Requires a Bachelor’s (Master’s degree preferred) in a related scientific discipline with 8-10 years’ experience in QA in a GxP regulated environment
  • Must have successful implementation experience and management of a QMS System
  • Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
  • Must demonstrate attention to detail and excellent record keeping skills
  • Must be proficient in MS Office Suite (e.g. Word, Excel, PPT) required for review and preparation of documents and reports for inspections
  • Proven ability to find creative, practical solutions to complex problems
  • Excellent communication and interpersonal skills
  • Superior and proven organizational skills
  • Ability to multitask and work in a team-oriented fast-paced environment