Sr. Manager, (GCP Clinical) Quality Process & Standards
Posted on: January 16, 2022
About This Role:
As a Sr Manager, GCP Clinical Quality Process & Standards, you will
provide end to end quality oversight of activities executed within
Global Clinical Operations (GCO) including studies, programs, and
processes, and 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). You will act as the Functional Quality Representative (FQR)
for GCO, liaising with the R&D Quality / Compliance team and
other FQRs, and operate within the define quality governance
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 GCP stakeholders, you will determine the overall risk for
quality issues, and facilitate the execution of CAPAs as required,
including the evaluation of the adequacy of the CAPAs /
Effectiveness Checks. Additionally, you will lead Study Risk
Assessments and be actively involved in pro-active inspection
What You'll Do
- Supporting the maintenance and development of the QMS by:
- Reviewing GCO process deviations for compliance and
- Participating in process improvements and functional
initiatives, as required.
- Reviewing and assessing controlled documents for possible gaps
with respect to quality, compliance, and regulatory
- 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
- 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
- Involvement in audit and regulatory activities:
- Contributing to audit planning and management of audit
- 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.
- Bachelor's Degree
- 5+ years' experience in clinical operations and / or compliance
or quality function or equivalent including onsite experience
(clinical monitoring/investigator site auditing)
- In depth understanding of GCP and global regulations and
standards that govern the development of clinical products (CFR,
ICH, EU Directives, as examples)
- GCP and regulatory clinical trial inspections
- Understanding of quality by design, risk assessments, quality
measures and metrics
- Excellent written and verbal communication skills, including
strong ability to facilitate meetings / discussions and influencing
without direct authority
- Ability to manage change and lead in an evolving
- Judgment and decision-making skills
- Master's or Advanced Degree
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
Keywords: Biogen, Cambridge , Sr. Manager, (GCP Clinical) Quality Process & Standards, Executive , Cambridge, Massachusetts
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