The Sr. Manager, QPS contributes to the strategy and implementation of quality oversight, best practices, and training within Global Clinical Operations (GCO) in support of the overarching Quality Management System (QMS). The position may delineate further to support either Quality/Compliance as a formal Functional Quality Representative (FQR) or providing Process and Standards leadership and support to relevant sub-functions within GCO or a hybrid of both roles.

FQR: This position is responsible for driving a culture of quality within GCO and will serve as an advocate for the QMS by acting as the FQR for GCO, liaising with the R&D Quality / Compliance team and other FQRs, and operating within the defined quality governance structure. Providing leadership and expertise for investigations of potential or actual quality issues pertaining to GCP. In consultation with GCO stakeholders, determine the overall risk for quality issues, facilitate the execution of CAPAs as required, including the evaluation of the adequacy of CAPAs/Effectiveness Checks. Additionally, the FQR takes an active role in Study Risk Assessments (SRA) and proactive inspection readiness activities for studies and programs.

Process & Standards: This position is responsible for leadership and coordination of selected GCO processes within the Process Owner Network (PON). In collaboration with relevant GCO sub-functions, they seek opportunities to identify and implement process efficiencies and adopt learnings resultant from quality issues, and findings from audits and inspections and/or the monitoring of industry best practices and trends. In this role, the Process & Standards Lead may assume ownership for key Process and Sub-Process areas and are the primary point of contact for those respective process areas during audits and inspection. This position is responsible for process level deviations, periodic reviews, process level CAPAs/Effectiveness Checks and the overarching inspection readiness for their respective process-space activities.

They provide consultation on process questions and requests across GCO, including process mapping and definition, controlled documentation, tool development and training. He/she is the primary liaison to the R&D learning function and the PON and they may contribute to and develop training programs pertaining to relevant processes and standards for GCO sub-functions.

What You’ll Do

• Reviewing GCO process deviations and periodic reviews for compliance and completeness.
• Participating in process improvements and functional and cross-functional initiatives in GCO and R&D.
• Reviewing and assessing controlled documents for possible gaps with respect to quality, compliance, and regulatory requirements and 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.
• Providing consultation on quality questions / issues for programs and studies and process areas.
• Evaluate risks and mitigation strategies and determine requirements for escalation and communication to functional/quality leadership.
• 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.
• Leading Study Risk Assessments for assigned studies.
• Contributing to audit planning and management of audit responses.
• Conducting and/or supporting site and sponsor inspection preparation for GCO, identifying key risks and mitigation strategies, coordinating site inspection management activities, and facilitating inspection responses as appropriate.
• Liaise with R&D Quality & Compliance team to ensure adequate coverage of audit and inspection activities.

Who You Are

The ideal candidate has strong attention to detail and enjoys working in a team environment and as an individual contributor.  They also enjoy using their in depth understanding of GCP to aid in the high quality-successful clinical trial execution.

Required Skills

• Excellent written and verbal communication skills, including strong ability to facilitate meetings / discussions.
• Must be able to manage change and lead in an evolving organization.
• Strong understanding of internal and external guidelines related to document preparation.
• Ability to identify areas for process improvement and lead discussions to implement change.
• Comprehensive decision-making skills.
• Understanding of quality by design, risk assessments, quality measures and metrics.
• Ability to partner and influence functional area colleagues
• 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, as examples).
• GCP regulatory inspection experience preferred.
• Clinical trial systems and process expertise.

Preferred Skills

• Master's or Advanced Degree preferred

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.

This position could be Hybrid (meaning 2 - 3 days per week on site) or Remote for the right candidate.  

The base compensation range for this role is $133,900 to $194,200. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.