Remote Manager Quality Assurance

eClinical Solutions

Mansfield, MA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 06/06/2021
  • Website: eclinicalsol.com
  • Company Address: 603 West Street , Mansfield, MA, 02048

About eClinical Solutions

eClinical Solutions seamlessly orchestrates clinical technology and expertise to help accelerate the clinical development process.

Job Description

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate®, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

 

OVERVIEW

 

This is role will have the primary responsibility to maintain Policies, Procedures and Oversight Corporate Compliance Program and Vendor Management process. In addition, this role will help lead Quality and Compliance tasks including but not limited to, Audits, Regulatory Inspections, Corrective and Preventative Action Process, Product QA Release Reviews, and Quality Management System needs as assigned and required.

 

This position will report to the VP, Quality and Compliance and collaborate closely applicable Subject Matter Experts.

 

KEY TASKS & RESPONSIBILITIES

 

  • Streamline and Maintain the Vendor Management Process
  • Participate as assigned Compliance representative to lead project teams in qualifying and validating corporate GCP computerized systems.
  • Suggest edits to improve process to include and draft improved process.
  • Better defined risk assessment
  • Improved forms and templates associated with process
  • Ongoing / periodic system reviews
  • Access control reviews
  • Develop, review, and/or approve the following as required:
  • Written procedures and policies (SOP’s, Validation Plans, IQ/OQ/PQ, etc.) that are part GCP use of computerized systems
  • Validation documentation created in to comply with the Computer System Lifecycle
  • Own and Maintain Compliance Risk Registry and Systems Inventory
  • Support the audit or inspection of any vendors or partner organizations relative to their creation of computer system products, use of computerized systems, or quality systems software, as assigned by management.
  • Lead and Represent the company during Client audits and / or related inspections.

 

CANDIDATE’S PROFILE

 

Qualification/Requirements

 

  • BS in Computer Science, Information Systems or related technical field, or equivalent IT Compliance and computer validation experience.
  • 5+ years experience working in Quality Assurance, Pharmaceutical/Biotechnology industry
  •  Strong knowledge of U.S. FDA & International Regulation of Computerized Systems
  • Strong experience managing compliance assessments within a corporate setting and working with various external auditors.
  • Strong working knowledge of Microsoft office 365 applications
  • Experience leading Compliance Programs
  • Staff Management skills a plus
  • Experience working with Enterprise level Quality Management Systems
  • Demonstrated skills in performing Risk Management services including performing system assessments, gap analysis, and providing remediation support.
  • Exceptionally self-motivated, directed, and detail oriented.
  • Superior analytical, evaluative, and problem-solving abilities.
  • Ability to motivate in a team-oriented, collaborative environment including Application Development, Infrastructure, and other impacted organizations.
  • Ability to present ideas and technology solutions in business and user-friendly language.
  • Strong project management skills.
  • Excellent communication (verbal and written), negotiation, presentation, and interpersonal skills.

 

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based  qualifications, merit, culture fit and business need.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.