Manager, Clinical Operations Quality Oversight

Biogen SANDBOX•Cambridge, MA

About The Position

As Manager, Clinical Operations Quality Oversight, you will provide quality oversight of activities executed within Global Clinical Operations (GCO), including studies, programs and processes. In addition, you will contribute to GCO audit / inspection planning, management and response generation. You will be responsible for driving a culture of quality within GCO and will serve as an advocate for the Quality Management System (QMS). As the Functional Quality Representative (FQR) for GCO, you will be liaising with the R&D Quality / Compliance team and other FQRs operating within the defined quality governance structure. You will provide leadership and expertise for investigations of potential or actual quality issues pertaining to GCP, and escalate as necessary per the quality governance pathway. In consultation with GCO stakeholders, you will determine the overall risk for quality issues, and facilitate the execution of Corrective and Preventative Actions (CAPAs) as required, including the evaluation of the adequacy of the CAPAs / Effectiveness Checks. Additional Information As Manager, Clinical Operations Quality Oversight, you will provide quality oversight of activities executed within Global Clinical Operations (GCO), including studies, programs and processes. In addition, you will contribute to GCO audit / inspection planning, management and response generation.

Requirements

2-5 years’ experience in clinical operations and / or compliance or quality function or equivalent.
In depth understanding of GCP and global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives).
Expe

Responsibilities

Supporting the maintenance and development of the QMS by: Reviewing GCO process deviations for compliance and completeness.
Participating in process improvements and functional initiatives, as required.
Reviewing and assessing controlled documents for possible gaps with respect to quality, compliance and regulatory commitments.
Engaging with Process Owners / Sub-Process Owners or functional area leads to review Key Quality Indicators/ tolerance thresholds and communicate quality and compliance risks.
Overseeing and supporting Quality Management within the GCO Function: By identifying process / functional risks and issues and mitigation strategies, determine requirements for escalation and communication to functional/quality leadership.
Providing consultation on quality questions / issues for programs and studies.
Monitoring functional metrics to assess compliance with processes and procedures and evaluating for potential quality signals / trends.
Implementing quality process reviews as needed.
Overseeing and approving CAPAs / Effectiveness checks.
Acting as quality liaison with vendor quality representatives as needed.
Involvement in audit and regulatory activities: Contributing to audit planning and management of audit responses.
Conducting site and sponsor inspection preparation for GCO, identifying key risks and mitigation strategies, coordinating site inspection management activities, and facilitating inspection responses as appropriate.