Hybrid Details: This position requires up to 15% travel in the Greater Boston area.

Duration: 12 months to start

Job Description:
GENERAL POSITION SUMMARY: The Manager, GLP Operational Quality supports the quality oversight for the GLP-related processes and activities.  The incumbent will support business partners and GLP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas.

The Manager, GLP Operational Quality will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. 

This individual will report to the Associate Director, GLP Operational Quality and will work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution of approaches across products and programs.

This individual will model leadership behaviors instilling a culture of quality, engagement, development and transparency.

KEY RESPONSIBILITIES:

• The responsibilities of this position may include, but are not limited to, the following:
• In collaboration with Preclinical Safety Sciences and Preclinical Development VCGT and with other internal stakeholders in the business and Quality to ensure appropriate quality/compliance oversight of preclinical activities across modalities.
• Participates in Regulatory Document reviews, identifying any potential risks or gaps.
• Provides input in development of audit scope/focus for vendor audits.
• Supports business initiatives involving processes, procedures, regulations and tools intended to support preclinical activities.
• Participates in strategic cross-functional initiatives to improve compliance to regulatory requirements, standards and internal client policies, including an effective, efficient GLP QMS as outlined in the FDA GLPs, and global equivalents.
• Identifies and anticipates potential compliance issues that may impact the ability to meet business goals; develops and implements methods of improvement and resolution in a pragmatic and effective manner.
• Contributes to proactive reporting of significant quality issues related to client Preclinical product development, ensuring an aligned Quality point-of-view is represented.
• Supports proactive inspection readiness activities for processes that impact product development, including conducting inspection readiness quality assessments of GLP studies. (IND enabling studies as requested)
• Serves in an advisory/consultative role in the development of an audit strategy for GLP vendors, processes and systems.
• Participates in engagement with R&D vendor quality to provide input for vendor performance and vendor risks.
• Serves as a key contributor to GLP governance meetings (e.g. QLT), collaborating with business and quality stakeholders to contribute to agenda topics and provide meaningful metrics.
• Contributes to providing input to appropriate quality metrics related to GLP activities.
• Ensures timely and effective communication of summary trending and other insights on the quality of delivery in preclinical/clinical studies to relevant business and quality partners and in relevant forums (e.g. Integrated Risk Teams)
• May participate in Due Diligence and integration activities as appropriate.
• This position requires up to 15% travel.

• Broad knowledge of FDA GLPs (21 CFR Part 58), and international equivalents, and other applicable guidance
• Demonstrated experience interpreting and applying GLP requirements across products to drive phase appropriate quality.
• Demonstrated ability to collaborate effectively at all levels to drive delivery in a dynamic, fast paced environment.
• Quality metrics, dashboards, analysis and improvement programs
• Excellent communication skills and a proven track record of influencing/building/promoting a culture of quality and excellence.
• Strong problem solving and critical thinking skills required to make sound decisions

• Lead by Example
• Learn, Teach and Develop.
• Foster Exceptional Collaboration
• Drive Break Through Results
• Promote Enterprise Thinking

• M.S. (or equivalent degree) 10+ years of relevant work experience, or
• B.S. in a scientific or allied health field (or equivalent degree) 13+ years of relevant work experience, or relevant comparable background
• Professional association membership and participation preferred, not required (for example, SQA, RQA)