The Quality and Compliance Manager (QCM) is a Full-Time role that reports to the Senior Director of Compliance (SDC). Compliance Manager supports the SDC with administering Continuum Clinical’s quality management system. This role supports the processing of the functional team’s standard operating procedures, coordinates internal and external audits, facilitates Corrective and Preventative Action plans, and liaises with employees who have regulatory and privacy-related questions.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties may be assigned.
• Demonstrate the mission, vision, values, and culture principles of Blue Chip Worldwide
• Advises internal Continuum Clinical teams on quality related topics, consults with Senior Director of Compliance when needed
• Supports Senior Director of Compliance on privacy and information security matters
• Manages the process for developing and revising policies and standard operating procedures (SOPs) across Continuum Clinical departments as part of a Quality Management System (QMS); consults with Blue Chip Worldwide as applicable
• Facilitates the remediation of issues and Corrective and Preventative Action (CAPA) plans
• Supports internal and external audit activities
• Develops and maintains department’s document filing structure and tracking system for Compliance requests
• Liaise with Learning & Development by providing Compliance point of view on training requirements and documentation
• Stays abreast of industry news related to industry-specific regulations
• Flexible hours may be required to accommodate global clients
• Responsible for maintaining up to date weekly time tracking, per the Agency’s time tracking policy.
• Comply with all corporate and departmental standard operating procedures as well as FDA and other governmental regulations (e.g. EU, ROW) as applicable.
• Ensure all activities and operations are performed in compliance with US federal and state regulations and global regulatory requirements. .
• Based on client and internal project demands, additional duties may be assigned.
Continuum Clinical Qualities
To be successful, every Blue Chip Worldwide employee should possess the following qualities:
• Attitude & Commitment – you are a passionate, resourceful and productive achiever that is a pleasure to be around
• Priority Setting – you define clear action steps and manage expectations of others
• Creative Thinking & Problem Solving - you recognize the relevancy of your ideas to the big picture, demonstrate original thinking and make an impact on your team
• Dependability – you are self-motivated to deliver the highest quality work, on time and budget
• Leadership Ability – you take initiative, motivate others and assume accountability for your actions
• Communication – you use organized, constructive communication to facilitate great work
• Intermediate knowledge of word processing software and presentation software
• Basic understanding of privacy and information security, including cloud computing
Education, Experience and Certifications
• Education: Bachelor’s Degree from an accredited four-year college or university
• Experience: Minimum 5 years’ experience within the pharmaceutical or healthcare industries, with at least 3 years experience in quality assurance and regulatory compliance
• Additional Experience: At least 2 years’ experience directly related to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
• Knowledge of ISO 9001 and 27001 or equivalent quality / information security management structure preferred
Requisition ID : 1208