Significant Quality Event Lead

At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies.

As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for.

Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives.

Purpose: 

To work with and on behalf of Clinical Development Quality within DevOps, performing management Significant Quality Events.

Significant Quality Event Lead:

The individual responsible for the formation and leading of the Significant Quality Event Team and coordinating all activities related initiating immediate action, conducting Investigation/RCA, developing corrective and preventive actions, as needed, and documenting case activities within appropriate database. Conduct broader impacts across the Pfizer portfolio to share learning's with other impacted study teams.

This position will include:

• Interaction with: A diverse range of stakeholders from varying internal lines 
• Ability to: be an effective project manager, leadership of Significant Quality Event Teams and/or Investigation/RCA Teams, progress delivery of actions 
• Understanding/knowledge of: GCP, clinical trial processes and systems , CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, inspection readiness

Organizational Relationships:

• Reports to GCP Compliance Manager

Primary Duties:

• Significant Quality Event management
• Forming Significant Quality Event Team
• Arranging meetings with Significant Quality Event Team, RCA Team, and/or Business
• Process Owner within timelines specified
• Documenting meeting outcomes in meeting minutes or other
• Facilitating Root Cause Analysis (or other types of investigation) and producing outputs
• Ensuring appropriate actions assigned and progressed to completion
• Updating the appropriate database
• Ensuring all documentation is filed appropriately

Training & Education:

• 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:

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 
• Ability to translate quality/compliance strategic imperatives into executable tactical plans

Detail/Comments Specific skills:

• Experienced in Quality areas: e.g. 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
• Acts independently. Most projects are self-initiated. Leverages knowledge from others related to overall objectives, strategy, critical issues, and policy matters.
• 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.
• 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

Experience:

• 3-5 years’ experience

All your information will be kept confidential according to EEO guidelines. 

IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-618-8925 ASAP! I want to know more about your preferences.

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