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Compliance Specialist
Ref No.: 18-02570
Location: Frederick, Maryland
5 years supporting Cell Therapy programs
5 years in an R&D role supporting the development of new products for commercialization.
Knowledge of product commercialization processes.

Key Responsibilities:

Maintain awareness of applicable standards and regulations, and monitor activities related to changes to the standards and regulations.
Stay abreast of all upcoming changes to Product Safety and Compliance regulations and standards to ensure the organization is meeting all current requirements for new and legacy products.
Provide leadership to projects ensuring design compliance requirements are understood.
Advise Divisional and BU leadership teams regarding strategies related to new and changing policies, regulations and standards, including assessment of business compliance risk.
Work closely with new product introduction teams to meet compliance requirements on schedule.
Oversee cell therapy projects from a design compliance perspective to ensure authentic, accurate, available, traceable, and compliant data that adheres to good design compliance expectations and all other applicable standards..
Interface with corporate partners regarding quality issues, audits, and special projects.
Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.
Prepare and/or review documentation required for regulatory submissions.
Maintain metrics for the design compliance team and continuously improve the area in terms of quality, efficiency and effectiveness.
Actively lead initiatives toward continuous development, training, mentoring, and/or coaching of staff.
This position is responsible for other duties as assigned.
Minimum Requirements/Qualifications:

Bachelor's degree in a technical or scientific discipline required.
Experience implementing Design for Compliance and training programs.
Experience with Cell Therapy Systems Development preferred.
Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.
Ten (or more) years of progressive professional experience, with a minimum of 5 years in management within a pharmaceutical/medical device Quality organization.
Strong knowledge of regulatory guidelines and their application.
Excellent written and verbal communication skills.
Ability to act quickly and decisively.
Preferred Requirements:

5 years supporting Cell Therapy programs
5 years in an R&D role supporting the development of new products for commercialization.
Knowledge of product commercialization processes.