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Jim Ure

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Head of GxP Quality Systems & Clinical QA

I am a passionate and innovative leader focused on fostering an organizational quality culture and driving strategic business results through effective leadership, collaboration, and proactive risk management.

My proven record of implementing sustainable QMS framework by providing valuable organizational and development support & oversight; by leveraging over 15 years of experience in Quality Assurance and Clinical Operations roles.

Key Info

  • Job Title
    Head of GxP Quality Systems & Clinical QA
  • Top 3 Skills
    Quality Assurance and Risk Governance Leader, Clinical Operations, Driven and Motivated Team Leader
  • Location
    Illinois
  • Will relocate?
    No

Key Skills + Experience


Experience


Head Of GxP Quality Systems And Clinical QA

Boston, Massachusetts / Chicago, ILlinois     2020-present

Quality Strategy. Develop and implement a robust corporate quality framework, inclusive of QMS-enabling programs to support drug development and achieve quality and corporate objectives.

Lead the Quality Management Team in establishing the company’s comprehensive quality framework, setting quality objectives, and assuring the Quality Management System remains fit-for-purpose to meet corporate goals and objectives; Collaborate with internal and external partners to implement a culture of Quality, using risk-based logic to ensure appropriate flexibility without compromising compliance; Implement an integrated Quality Manual to support a rapidly growing organization.

Quality Systems. Lead development, implementation and maintenance of phase-appropriate quality systems and SOPs to support GMP, GLP, GCP, CSV and PV and assure compliance, including training, document control, GxP records management, internal/external audit, vendor qualification & management, and noncompliance/CAPA management.

Provide guidance to operational functions to ensure that activities sponsored by the Company are conducted in compliance with GxP regulations and internal requirements; Author, review and approve controlled documents to assure alignment with internal and external expectations, including regulatory guidance and regulation; Monitor Key Performance Indicators (KPIs) and identify need for continuous improvement activities to assure appropriate maintenance of quality systems.

Computer Systems Validation. Establish computer system validation (i.e. Part 11/ Annex 11) program to ensure that GxP computerized systems consistently fulfill their intended purpose and produce results that are accurate, reliable, consistent and have integrity.

Maintain CSV-related policies and SOPs; Approve final validation documentation packages for the managed GxP systems.

Inspection Readiness. Provide oversight across GxP quality systems to minimize risks and promote real-time inspection readiness.

Conduct frequent QC activities to identify risks and inconsistencies across organization; Collaborate across GCP, GLP, GMP, CSV, and PV to assure fit-for-purpose implementation of quality management processes; Lead company preparations for regulatory inspections, which includes developing Inspection Readiness Plans, driving internal audits of Quality Systems, providing strategic direction for Mock Inspections, and conduct & follow-up activities for inspections performed by Health Authorities.

Development Support. Provide GCP and quality expertise and strategic leadership to drug development programs.

Provide guidance on the de-risking of protocols and study plans; Develop risk-based audit strategy to assure adequate quality oversight and compliance with regulatory expectations, policies/ SOPs and written agreements; Manage vendor qualification program and maintain an approved vendor list for clinical vendors; Collaborate with internal and external customers to develop and execute Quality Plans for clinical studies; Support the resolution of internal and external compliance issues by providing an assessment of the impact of deficiencies and by approving the implementation of CAPAs to ensure compliance issues are adequately addressed.

Associate Director, Quality Systems Design and Delivery

Boston, Massachusetts / Chicago, ILlinois     2017-2020

Developed and implemented QMS-enabling programs to support drug development and achieve quality objectives; Led cross-functional assessments & investigations to assure holistic oversight of GxP processes; Championed and drove proactive risk management strategies to reduce non-compliance and promote effectiveness.

Senior Manager, R&D Quality Assurance

2015-2017

Partnered with Clinical Operations to provide direct GCP support in clinical programs, including remediation of observations and quality issues; Led development of the GCP inspection readiness & delivery program; Led GCP compliance program to improve visibility to performance information.

Clinical Support. Partnered with QA, Clinical Operations and other GxP functions to provide support in driving high-quality outcomes in the delivery of clinical programs.

Led large, cross-functional investigations, resulting in process improvement and dramatic reduction in non-compliance; Led, supported and approved creation and implementation of CAPA plans resulting from GCP non-compliance (e.g. observations, Quality Issues and Deviations); Participated in building risk-based approaches to auditing, vendor oversight and CAPA management; Established GCP and GLP quality policies to articulate minimum requirements for operational activities.

Inspectional. Supported organizational inspection preparedness and readiness through serving in key roles and implementing GCP inspection program.

Hosted, managed, and supported sponsor and site GCP inspections across US and EU; Led Global Inspection Readiness Team in support of GxP inspection forecasting, trending, and remediation; Led implementation of GCP inspection readiness & delivery program, including development of a GCP Inspection Scorecard; Led submission of MHRA GCP Inspection Dossier and implementation of sponsor storyboards/ dossiers.

Risk Management. Established formalized Quality Risk Management implementation and governance, in addition to supporting day-to-day risk management activities,

Led formation of Integrated Risk Governance Teams to provide oversight of and insight to risks across programs; Introduced and established program-based Quality Risk Management Plans to describe organization’s approach to assuring quality within programs per ICH Q9, ICH E6(R2) and upcoming ICH E8(R1); participated in industry forums to determine best practices for implementing QbD principles in clinical development, in alignment with Clinical Trials Transformation Initiative (CTTI) and ICH guidelines.

QMS Framework & Governance. Implemented fit-for-purpose QMS approaches within GxP and GCP to align with ICH Q10 and the TransCelerate QMS initiative.

Led GxP assessment of QMS to identify risks and opportunities to enhance processes to meet organization needs and regulatory expectations; Simplified SOP architecture to align with regulatory agency expectations and industry standard; Established GxP Quality Scorecards to provide oversight to organizational risks and performance; Implemented a GxP Regulatory Surveillance program to define and support end-to-end process for ensuring compliance with evolving regulatory landscape.

Leadership & Organizational Advancement. Leveraged organizational awareness and leadership skills to drive business objectives and promote a results-oriented & collaborative culture.

Developed, implemented, and monitored department’s strategic plan to define key customer deliverables, ensure talent satisfaction and prepare for future business needs; Built teams and developed competency matrices to provide a framework for talent development; Championed membership and active participation in Avoca Quality Consortium; Led Mentoring Circles program for Women’s Leadership Employee Resource Network.

Clinical Research Associate, Global Functional Resourcing

Chicago, Illinois     2007-2015

Specialized in monitoring GCP compliance with regulatory requirements and study protocols at high-risk (e.g. research-naive and significant non-compliance) investigative sites; Maintained accountability for investigator site management and oversight from site selection to site closure; Conducted site prospecting, qualification, selection, monitoring and closeout visits.

Clinical Support. Managed and advised high-risk investigative sites in establishing and maintaining GCP compliance through innovative training techniques, implementation of fit-for -purpose SOPs and collaborative process development.

Leadership & Team Advancement. Generated process improvement initiatives to optimize CRA performance metrics, standardize site management report reviews and minimize the risk of insufficient monitoring and site non-compliance findings.

Clinical Research Coordinator

Chicago, Illinois     2006-2007

Executed study visits per GCP regulations & guidelines, sponsor protocols and institution policies & SOPS; ensured documentation of activities met ALCOA standards; prepared and submitted regulatory documents for IRB approval; maintained appropriate archival of study documentation and regulatory files in investigator site files.


Therapeutic Area and Modality Experience


Therapeutic Areas    

  • Cystic Fibrosis
  • Hemoglobin Disorders (SCD & ?-Thal)
  • Endocrinology (DM1 & DM2)
  • Muscular Dystrophy (DMD)
  • Neuroscience (MDD, GAD, B1D, SAD)
  • Urology (ED)
  • Gastroenterology (Crohn’s & UC)
  • Ophthalmology

Modalities

  • Small molecules
  • Biologics
  • Gene therapies
  • Cell therapy
  • Delivery devices

Interests and Style


Building effective and genuine relationships through strong communication, engagement, and respect.

Developing and motivating talent to create an inclusive and high-performing culture.

Driving results and accountability in an evolving and complex landscape through effective leadership.


Education


Bachelor Of Science, Chemistry

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