CTPQ QQI Case Leads

Description

Role Purpose To work with and on behalf of CTPQ/CQM within DevOps, performing QQI management. QQI Lead: the individual responsible (from Clinical Quality Mgmt (CQM) or other qualified role) for the formation and leading of the Case Team and coordinating all activities related to assessing significance, initiating immediate action, conducting RCA, developing CAPA as needed, and documenting case activities within appropriate database.

This position will include:
1. Interaction with: A diverse range of stakeholders from varying internal lines
2. Ability to: effectively project manage, leadership of QQI Teams and/or RCA Teams, progress delivery of actions
3. Understanding/knowledge of: GCP, clinical trial processes and systems, CAPA, quality issues, Root Cause Analysis, regulatory requirements, quality management, inspection readiness

Organizational Relationships:

Reports to Clinical Quality Manager

Primary Duties: (at minimum)

QQI management

Forming QQI Team

Determine significance and/or category of QQI (with team), follow-up as needed

Arranging meetings with QQI Team, RCA Team, and/or BPO within timelines specified

Documenting meeting outcomes in meeting minutes or other

Facilitating Root Cause Analysis and producing outputs

Ensuring appropriate actions assigned and progressed to completion

Updating the appropriate database

Ensuring all documentation is filed appropriately

Training & Education Preferred:
Degree in one of the disciplines related to drug development or business. Advanced/in-depth knowledge which may include quality audit, quality management, inspection readiness, quality and compliance assessments, CAPA Management, continuous improvement methodology, root cause analysis. Knowledge of clinical trials operational processes and systems which may include study management, data management, reporting, and project management.

Prior Experience Preferred:

Understanding of clinical trials

Ability to work successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a Matrix organization

Experience of leading global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.

Knowledge of quality requirements across a range of different countries

Strong influencing skills with ability to influence a broad range of global stakeholders.

Excellent communication skills adaptable to meet the needs of diverse stakeholder groups, internal and external.

Record of achievement and delivery for personal and team goals.

Ability to balance and prioritize a diverse and demanding workload.

Works independently and proactively set own work agenda with minimum guidance.

Technical Competencies: Competency Detail/Comments (specific skills, etc.)

Quality related experience including familiarity with:

ICH GCP, and Regulatory obligations

Quality and compliance management, QC

Project/initiative coordination and management skills

Root Cause Analysis

Experienced in Quality areas: eg audit, inspection, compliance, CAPA management, and inspection readiness fields

Project Management skills/experience

CI/RCA skill and experience

Knowledge of ICH GCP and regulations in order to assess GCP situations and appropriate actions

Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement.

Need clinical trial experience. CANDIDATES NEED FOCUS MORE ON QUALITY VS. CLINICAL TRIALS.

Behavioral Competencies:
Competency Detail/Comments (specific skills, etc.) Ability to translate quality/compliance strategic imperatives into executable tactical plans

Makes strategic use of quality/compliance data to monitor & raise performance

Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards

Responds to changing situations and others' ideas that differ from own positively and constructively

Having the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken.

Encourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for others

Lobbies key internal and external stakeholders to ensure success

Looks for opportunities for collaboration and acts upon them

Work with others to ensure close collaboration and support

Exercises foresight and judgment utilizing comprehensive breadth of knowledge and prior work experience

Acts independently. Most projects are self-initiated. Leverages knowledge from others related to overall objectives, strategy, critical issues, and policy matters.

MOST CRITICAL SKILLS REQUIRED:
Clinical Trial experience, Quality audit or quality management experience, project management ability, lead teams, directive approach, CI/root cause analysis experience.
Required to have a working knowledge of clinical trials

REQUIRED PERSONALITY TRAITS:
Self-directed, but works well in team environment, strong leadership skills, diligent, responsible, communicative, reliable.

Project Name:
Qualifying Quality Issue (QQI) Management for "Maintained" and "In Transition" Portfolio The QQI Lead will facilitate and manage quality issues and CAPAs (Corrective and Preventative Actions) through the process for protocols in the "maintained" portfolio (ie those clinical trials that will not transfer to Alliance Partners but will complete in current outsourcing model) and "in transition" portfolio (ie those clinical trials that will transfer to Alliance Partners but will do so in "waves.") Anticipated Milestones and Associated
Timelines: Milestone Hard Transition Date Estimated Lagging Timelines (ie time to close quality issues and/or CAPAs opened prior to full transfer to Alliance Partner) Transition of Wave 2* Protocols November 2012 May 2013 Transition of Wave 3 Protocols February 2013 August 2013 Transition of Wave 4 Protocols May 2013 November 2013.Note - wave 1 transition already completed.
Project Duration: The project duration is anticipated to be up to 2 years with current estimates of end in ~ November 2013.
Final Deliverable: The Qualifying Quality Issue (QQI) Management project will continue through the waves and until the Clinical Quality Management organization has completed its transformation from a central clinical quality management team to an asset-focused one. The final deliverable signalling end of project will be closure (in relevant QQI database) of the last quality issue/CAPA associated with any protocol in the transition or maintained portfolio.

SKILLS

Project Timelines, Resource Management
Synectics is an Equal Opportunity Employer.