Director of Quality & Compliance

Company: Kforce
Location: Fort Lauderdale
Posted on: January 12, 2021

Job Description:

DescriptionKforce has a client seeking a Director of Quality & Compliance in Fort Lauderdale, FL.Responsibilities: Work within Quality & Compliance team to identify, define, maintain and improve companywide procedures ensuring a sound Quality Management System (QMS) Assure process compliance with federal regulations, company procedural requirements and international privacy regulations Interface with all levels of management to successfully manage and maintain Quality System documentation, departmental policies, best practices, and corrective & preventative action process Inform management of any corporate non-compliance incidents or regulatory compliance issues, which may arise internally, or with customers, vendors, or contractors Oversight of validation deliverables of company's core applications and customer-specific developments; manage computer systems validation plans, validation reports and related documentation, responsibility of validation timelines of projects Perform internal audits on staff/systems for adherence to SOPs/project specifications Perform or coordinate external audits for company suppliers Host client audits Coordinate follow up actions resulting from audits and issue recommendations on areas requiring corrective action. Mentor Quality & Compliance staff.Requirements 7 years of industry experience in an FDA regulated or formal quality system environment Background in computer control environments, experience with internal controls, risk assessments, QA operational auditing, change management Broad knowledge of relevant industry and government regulations including 21 CFR Part 11, Guidance for Industry: Computerized Systems Used in Clinical Investigations, and ICH GCP Guidelines and international privacy laws Demonstrated team and organizational leadership, development and support to direct reports and colleagues Experience in developing and implementing processes and procedures Acts firmly and responsibly to ensure all compliance and quality issues are noted and addressed, including analyzing findings and making recommendations for resolution Ability to exercise sound judgment, organized and thorough approach to work Excellent oral and written communication skills Certification/experience auditing Quality Systems preferred Experience in the EDC process is preferredKforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Keywords: Kforce, Fort Lauderdale , Director of Quality & Compliance, Executive , Fort Lauderdale, Florida