Quality Assurance Specialist III

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
Cambridge, Massachusetts
Posting date: 21 Feb 2019

ProClinical are working exclusively with a leading global pharmaceutical company that specialises in in multiple therapy areas. This organisation is currently advertising a vacancy for a Quality Assurance Specialist III. This is an exciting opportunity to join this company's team in Massachusetts.

The Quality Assurance Specialist will help deliver on company commitments for patient safety, product quality, and data integrity by ensuring the quality and regulatory compliance of computerised systems and regulated data. They will provide independent oversight of computerised system validation and operational activities to confirm that computerised systems and regulated data are maintained in compliance with applicable Healthcare laws and regulations, along with company policies and procedures. The QA Specialist will also drive and sustain improvements to computerised systems and the processes for implementing and supporting them.

Job Responsibilities:

  • Providing independent oversight to assure that computerised systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations, and guidelines.
  • Promoting and championing support of compliance, quality, and best practice-oriented culture regarding computerised systems.
  • Authorising validation deliverables produced for computerised system projects, including operational procedures, maintenance procedures, and change requests.
  • Supporting the development of CS QA related procedures.
  • Participating in ongoing operational management activities, including but not limited to, demand management, the Change Advisory Board, and Quality Metrics.
  • Conducting audits of computerised system vendors and 3rd party software providers, including SaaS.
  • Providing expertise and support during audits and inspections of the company.
  • Identifying and reporting any quality or compliance concerns and taking immediate corrective action as required.
  • Proactively identifying risks and issues; driving implementation of pragmatic, compliant, and quality-based solutions.
  • Leading on-going initiatives and improvement projects in areas related to computerised systems and regulated data as assigned.
  • Proactively identifying and sharing emerging industry standards/trends with business partners in the area of regulated computerised systems and regulated data.
  • Planning, executing, and reporting on internal audits of activities, records, and processes related to regulated computerised systems and regulated data.
  • Supporting the response and remediation of corrective actions and internal audits.
  • Collaborating with key business partners, including IT, Vendors, Quality SMEs, and Business System Owners to ensure activities are performed in line with company procedures, regulatory requirements, and industry standards.

Skills and Requirements:

  • A Bachelors' degree in Science, Business, Engineering, IT, or related discipline; alternatively, 5 years of equivalent professional experience will be considered.
  • At least 6 years of experience with FDA Regulations, ICH, EMA and/or other international healthcare regulatory requirements.
  • At least 4 years of experience working with IT systems and team.
  • Experience making quality assurance and compliance decisions regarding software development, validation, and support.
  • Demonstrable experience with all phases of software validation and infrastructure qualification.
  • Demonstrable experience with all phases of System Development Lifecycles principles, processes, and procedures.
  • Demonstrable experience in working as part of a 'virtual' team.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, persuasion, influence, and leadership.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

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 Kevin Cassini on +1 215 531 5288 or upload your CV 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.