Combination Products Design Control Manager

Proclinical is currently recruiting for a Combination Products Design Control Manager with a pharmaceutical company located in St. Louis, MO. Successful candidate will provide input and review for the remediation of combination product related design projects, quality system records and design control procedural deliverable requirements. Guides design verification and validation plans. Assesses and improves systems, procedures and practices. Approves protocols and reports as needed.

Job Responsibilities:

• Leads the sites Design Control remediation efforts, including establishing and revising system and procedures governing Design Control.
• Establishing and maintaining DHFs, DMRs and DHRs.
• Establishing and maintaining Design Inputs and Outputs
• Ensuring Product Requirements/Specifications are clearly defined
• Developing/reviewing Design Verification/Validation protocols and reports
• Establishing appropriate Design Review stages and participating in design reviews
• Developing and coordinating required Transfer activities
• Establishing and maintaining Design Change Control processes
• Risk Management Integrations
• Manage engineering staff to conduct Design Control reviews and prepare updates to key documents/procedures.
• Review and Approve Design Control File documentation.
• Provide Design Control related training as necessary

Skills and Requirements:

• BS/BA, MS or PhD in a relevant discipline.
• Experience: A minimum of 10 - 20 years of Medical Device and or Combination Products. Experience with the practical application of Design Control 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.
• Attendance and participation in various departmental and site leadership team meetings will also be required.
• 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.
• 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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