Combination Products Risk Manager

Proclinical is currently recruiting for a Combination Products Risk Manager with a pharmaceutical company located in St. Louis, MO. Successful candidate will provide oversight and guidance for the remediation of Risk Management file lifecycle activities for Auto Injectors products manufactured at the site. The position will provide input and risk review for combination product related design projects, quality system records and design control procedural deliverable requirements.

Job Responsibilities:

• Leads the sites Risk Management remediation efforts, including establishing and revising system and procedures governing risk management.
• Review and establish link to the risk file for complex/significant CAPA, investigation and Change Management records
• Facilitate remediation efforts for risk assessment activities, risk mitigation strategies and risk management plans; provide review/approval as needed
• Review and Approve Risk File documentation
• Ensure risk management system linkage to validation and maintenance functions
• Utilize Design History and Risk File documents to assess risk resulting from complex/significant changes, manufacturing events and customer complaints
• Present the risk file documents during Design Reviews
• Provide risk management related training as necessary

Skills and Requirements:

• BS/BA, MS or PhD in a relevant discipline.
• 10 - 20+ years of Medical Device and or Combination Products. Experience with the practical application of risk management concepts within FDA regulated industry. Knowledge of ISO risk management standards and demonstrated applied knowledge of Failure Modes Effect Analysis (FMEA), CAPA, Root Cause Analysis and statistical methods as applied to Quality.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
• Attendance and participation in various departmental and site leadership team meetings will also be required.
• The position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
• Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Max Kelly at (+1) 312-270-1613 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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