Product Risk Manager

June 26, 2019
North Reading, MA
Job Type


The Senior or Principal level Product Quality Specialist will fulfill a new technical role in the Regulatory and Quality Compliance team to ensure that the TraceLink Life Sciences Cloud and other TraceLink software product offerings comply with global regulations (21 CFR 11, Annex 11, 21 CFR 820, 21 CFR 211, ISO 27001, ISO 9001, FDA guidance documents, GAMP5, etc.), and customer requirements.


Risk Management: Review and gap assessment of requirements and related risk management plans and activities; ensure testing and traceability of requirements from inputs through documented outputs; identification of applicable standards; and review of specifications, test methods/test plans.

Independent Reviewer: Perform review and approval of Software Development Lifecycle (SDLC) deliverables and releases; perform product release management activities; and create, review, approve, and manage Validation documentation in collaboration with Engineering and Product Management.

Validation Support Activities: Create and deliver IQ and OQ documents to customers, perform and document internal tool qualifications, support product offerings, and identify validation and verification or qualification process improvements.


  • Understand the processes and intent of all aspects of the Quality Management System (QMS) and ensure organizational compliance with global regulations, TraceLink QMS processes, and customer requirements.
  • Establish and maintain open communication and close collaboration with Engineering, Software QA, and Product Management teams during SDLC release projects; during review of product requirements, technical designs, and test plans; to ensure effective and robust testing is performed for each release; to identify risks / escalations and mitigation plans; and during the release approval process.
  • Participate in the software deployment and IQ verification process for system upgrades, including planned and unplanned releases.
  • Lead development of a Risk Register process for the SDLC to identify high risk changes, track mitigation plans and activities, and ensure compliance with risk management processes. This may include leading risk analysis meetings, documenting results, following up to ensure risk mitigation, and facilitating improvements.
  • Investigate escalated customer issues and perform root cause analysis as part of the Corrective and Preventive Action (CAPA) program. Ensure corrective and preventive actions are completed and effective.
  • Communicate significant issues or concerns identified during SDLC and risk management activities and provide recommended process improvements to management.
  • Develop and update SOPs related to areas of responsibility.
  • Support customer audits or requests for information. Support internal audits and vendor audits.
  • Contribute to quality metrics and key performance indicator reporting, Quality Plan objectives, and team initiatives.



  • BS in Engineering, Computer Science, Information Systems, or scientific discipline.
  • 5-7 years performing SDLC, system validation and verification activities, and risk management.
  • Demonstrated knowledge of global regulations specific to Software Development, Risk Management, and Pharmaceutical or Medical Device or Supply Chain industry (e.g., DSCSA, 21 CFR 11, Annex 11, ISO 14971, ISO 9001, ISO 27001, ISO 13485, ISO 31000, NIST, 21 CFR 820/211, GAMP5, ICH Q9 and Q10, UDI, MDR).
  • Strong interpersonal, communication (verbal and written), collaboration / approachability, and project management skills. Ability to be persuasive and gain buy-in from cross-functional team leaders.


  • Familiarity with cloud-based software systems qualification, risk management, agile SDLC, continuous validation.
  • Familiarity with Amazon Web Services (AWS) platform.
  • Current Lead Auditor certification (ISO 9001:2015, ISO 13485:2016, etc. or similar) or Risk Management certification (ISO 14971: 2007 or 2012 or similar).
  • 1-3 years of Supplier/Vendor audit experience.

Company Description

TraceLink is the leading SaaS solution provider in the life sciences industry for track and trace software. As one of the fastest growing technology companies, TraceLink founders have been working with the pharma industry and federal regulators since 2003, to first determine how to secure the life sciences supply chain with digital technology and then implement track and trace regulations at a global level.

In 2010, TraceLink launched the Life Sciences Cloud, a comprehensive global track and trace platform that is natively integrated with Amazon Web Services, designed to minimize risk, cost and time in meeting diverse and evolving global track and trace requirements. Lifting the pharmaceutical supply chain into the cloud was a first for the industry and has proven to be the leading technology platform, uniquely offering a social network of trading partners to provide visibility into the path of pharmaceutical products traveling through the supply chain. The 265,000+ members on the TraceLink network range from pharmaceutical companies, contract manufacturing organizations, wholesale distributors, parallel importers, repackagers, third-party logistics providers, pharmacies, hospitals, clinics and physician offices.

Through its innovative Integrate Once, Interoperate with Everyone™ approach, the TraceLink network enables companies to link to any business, seamlessly exchange data and collaborate on key business processes. This unique approach is designed to relieve the burden of managing massive amounts of serialized data, complex compliance transactions and government reporting by continuously monitoring and updating the platform to meet changing regulatory requirements.

TraceLink is a winner of numerous industry awards including three consecutive years on Deloitte’s Technology Fast 500 (ranked number 177 in 2017), the Amazon AWS Global Start-Up Challenge Grand Prize, and the Edison Award for Innovation in Data Security.

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