Job Details

  • Title: Quality Assurance Lead
  • Code: RCI-03463
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 01/13/2021
  • Duration: 6 Months
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  Job Description

Quality Operations Partner – Research & Early Development

The selected candidate for this position will be temporarily acting as the Quality Operations Partner/Expert, Research & Early Development, a member of the Digital (IT) Quality Operations team supporting the R&D and Medical IT application and project teams. In this capacity she/he provides expertise and guidance on Quality & Compliance (Q&C) in a (primarily) GxP-regulated and very dynamic environment under the supervision of the Head of Digital (IT) Quality Operations R&D and Medical.

She/he is the point of contact for IT Service Lines supporting the Research & early Development, Translational Medicine and Global Clinical Immunology & Development business areas and collaborates closely with IT Service Line Leaders and Service Owners to identify and address Q&C requirements related to their application and project portfolios.

In addition, key responsibilities include providing Computerized System Validation expertise, guidance and oversight for regulated systems, supporting audits & inspections, providing awareness and training to Quality, Compliance and software development lifecycle topics.

The position requires detailed knowledge of and experience with regulations and software validation requirements in the Pharmaceutical/Biotechnology industries and the ability to successfully collaborate in multi-cultural and multi-disciplinary teams across locations and time zones

Knowledge and Skills:

• Broad understanding of information technology solutions in pharmaceutical R&D, esp. in early/pre-clinical development
• In-depth knowledge and several years of experience with Quality Management, GxP regulations and Computerized System Validation (CSV) as they pertain to this business area as well as awareness of other regulations (such as data privacy)
• Practical experience with using agile methodologies as well as implementing cloud-based solutions in a regulated environment is highly desirable
• Effective oral and written communication (in English) with various stakeholders, including technical teams as well as R&D IT Management
• Ability to build strong customer relationships, effectively contribute to and influence decision making, and resolve conflicts with stakeholders with tact and diplomacy
• Work and communicate effectively as a member of global, cross-functional, multi-national project teams or work groups
• Work autonomously and execute activities of varying complexity with limited supervision
• Coordinate with managed service provider for Quality Services as required in the scope of projects and applications

Major Duties and Responsibilities:

Supporting Relationship Management with Digital (IT) R&D Service Lines:
• Be the point of contact for and partner with the Service Lines to promote quality and compliance throughout the system life cycle
• Plan for and provide appropriate Quality & Compliance support for the project and application portfolios of the Service Lines in collaboration with the Head of Digital (IT) Quality Operations R&D and Medical.
• Provide awareness and training on Q&C topics, including Quality Management System, CS validation and lifecycle methodology (as required in collaboration with other Quality Operations team members)
• Coordinate and collaborate with transversal Quality Operations teams to provide services such as Audit and Inspection support, CAPA Management, Third Party Audit and Risk Management

Computerized Systems (CS) Validation, Change and Risk Management:
• Advise and guide project and application teams on and oversee validation activities in collaboration with Business Quality and our managed service provider for Quality Services
• Ensure compliance of programs/projects and applications with applicable regulatory and internal requirements by leading risk assessments, validation and testing strategy, planning and closeout – in collaboration with our managed service provider for Quality Services
• Work jointly with IT Quality Risk Managers and application teams to ensure compliance risks related to applications are properly detected, documented and addressed.

Audits and Inspections:
• Collaborate with Audit/Inspection readiness team members, Business System owners, Business Quality and Service Line representatives to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the Quality Management System

Global role. Point of contact for ITS group, for quality and compliance. GxP compliance. Will be primary advisor. Will interact with management for project portfolio.

Really two parts to this role: Customer service relationship management role and Quality compliance role related to computerized systems.

Looking for: someone who can work autonomous and interact with people outside the team. Someone who has good soft skills. High level knowledge of compliance. Can serve in advisory capacity. Background in research in early development area would be useful. Using HP ALM, Jira/Confluence. SharePoint, teams, the office tools useful as well. Job is remote, needs to work Eastern time zone hours.