To provide regulatory interpretation, consulting, training and assessment of the organization to ensure Company systems are aligned with current regulatory requirements, standards and industry trends. Ensure that systems are implemented to ensure compliance issues are addressed in a timely manner. Provide guidance and support for department staff to ensure departmental goals and responsibilities are met.
Understands, interprets and influences regulatory requirements such as: National Regulatory agencies (FDA, MDA, etc), Standards organizations (ISO, IEC, AAMI, ICH, etc.), Notified bodies (BSI, TUV, TNO, etc.)
Provides regulatory compliance guidance and decision making for the company in order to be fully compliant with government and corporate requirements and will provide leadership to support cultural changes and process improvements and ensure adequate resources.
Hires, retains and develops qualified personnel, as well as resolving all personnel issues and employee performance management.
Participates in the development of functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality control system development.
Translates external regulatory requirements into balanced decision-making with business strategies and effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.
Understands and effectively manages and recognizes recruiting, developing and managing personnel.
REQUIRED SKILLS AND ATTRIBUTES:
Demonstrated management/supervisor related experience.
Excellent leadership and management abilities..
Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
Good working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc.
Keen ability to accurately discern priorities in a resource constrained work environment.
Ability to effectively train and educate internal staff on procedures and regulatory issues.
Demonstrated ability to develop effective procedures and to write clear, consistent, thorough SOP’s.
Excellent verbal and written communication skills.
Bachelor’s degree in applied or life science or business with at least five (5) years of increasing responsibility experience, at least half of which must be supporting clinical trial operations.