Associate Director Study Quality Operations

Under the direction of Director Study Quality, the Associate Director (AD) Study Quality Operations Lead is accountable as Quality Partner for Clinical Operations and Clinical Development globally and is responsible for driving a culture of data and risk driven quality oversight of the Rare Disease Business Unit portfolio across all therapeutic areas at asset/ program level.

The AD is responsible to actively engage with cross functional study teams to support a culture of sustainable regulatory compliance via the risk-based quality management principles within and across portfolio. The AD, study QOL will act as clinical compliance advisor/partner to the global study team. Additionally, this position will be responsible for proactively assessing process efficiencies and building remediation/optimization in partnership with business process owners.

Under the direction of Director Study Quality, the AD, study QOL will partner with business process owners to drive the excellence of business-critical processes/platforms such as TMF, CRO/vendor oversight etc. They will support quality oversight of the Asset level audit and GCP inspection program execution by successfully partnering with relevant quality and functional SMEs, to assure successful inspection outcomes and CAPA Plan execution.

In consultation with cross-functional stakeholders and in close collaboration with other quality teams, (R&D, Central etc.), Country Quality QOL, the study QOL will support all audits, inspection readiness, preparation and management, Quality Event management and CAPA Plan development, and execution to closure. This includes but is not limited to proactively identifying and communicating/escalating critical-to-quality risks and issues to Clinical Development and Operations Management, including GPT, RST etc. and supporting these risks and issues through action and resolution.

You will be responsible for:

• Use knowledge of GCP/GxP, clinical development, and industry best practices in order to provide guidance, training and input to business partners on compliance issues. Able to adapt precedent and develop creative and effective solutions to solve problems.
• Develop, lead and support Enterprise level initiatives
• Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs
• Lead development and or provide guidance to team members in review of Clinical Trial Document Templates, study related documents, SOPs, Policies, etc., as needed.
• Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues
• Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.)
• Actively participate in meetings driving quality and business performance
• Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area
• Be accountable for leading inspection readiness for assigned programs/portfolio including but not limited to:
• Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable e.g., TMF health oversight, CRO/Vendor oversight, medical device requirements etc.
• Reviews and approves Deviations and CAPAs
• Work with cross functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality Management
• Support and drive risk-based quality management (RBQM) activities for the planning and execution of clinical protocols, assuring an ongoing cycle for Plan – Do – Check – Act.
• As appropriate escalate issues of critical noncompliance and/or lack of urgency in remediation to CDOQ and appropriate operational Leadership
• Serve as the quality expert for global/systemic clinical quality issue investigations, which includes:
• Represent CDOQ in Due Diligence and integration activities where applicable
• In collaboration with Clinical operational/development issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis
• In alignment with Director Clinical Development and Operations Quality, the AD, Study QOL supports development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio across all Therapeutic Area(s) (TAs)
• Collaborate with cross-functional stakeholders to support audits, inspection readiness, preparation and management, Quality Event management and CAPA Plan development, and execution to closure. This includes but is not limited to proactively identifying and communicating critical-to-quality risks and issues to internal R&D executive level management and supporting through action and resolution
• Participate in quality management reviews, risk reviews, and other study/TA/Asset level quality reviews to drive Clinical development and Operations Quality deliverables
• Where applicable provide appropriate quality metrics for established Quality Management Reviews (Global Quality, R&D etc.).
• Represent CDOQ in leading/supporting Diversity, Inclusion & Belonging
• Provide guidance or collaboratively works with Audit Team, R&D Center of Excellence, Central Quality, Global Sourcing and Alliance Management to ensure a robust clinical audit, Inspection and Clinical Vendor oversight strategy. May serve in an advisory/ consultative role in development of audit strategy for clinical programs, process and vendor audits
• In collaboration and coordination with other DOQS members, support development of appropriate vendor quality oversight plans and processes
• Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance
• Where applicable, represent CDOQ Quality on Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to proactively identify critical to quality risks and mitigation strategy to drive excellence in study execution and to minimize risk to regulatory submission/approval.

You will need to have:

• Functional planning experience and ability to develop functional vision, priorities and tactics
• Established knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)
• Experience participating in regulatory inspections
• Experience with multinational products and regulations as well as with mandated risk management plans
• Significant experience with GxP investigations, risk assessments and CAPA management
• Bachelor’s degree in life science, or equivalent field, required
• Ability to travel up to 10%
• Experience in managing, mentoring and directing people
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Minimum of 8-10 years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance

We would prefer for you to have:

• Competencies to be successful for this position include:
• Advanced degree preferred
• Strong interpersonal skills
• Teamwork
• Quality, process, and compliance oriented
• Integrity
• Problem solving
• Communication
• Critical thinking