Director, Quality Management & Compliance PHT
THIS JOB HAS EXPIRED The Director of Quality Management and Compliance has the responsibility, accountability, and authority to plan, direct, and administer PHT?s quality system, including the establishment, implementation, and maintenance of company quality system policies and procedures, monitoring programs, and evaluating in-house and supplier programs through audit.
Maintain PHT?s overall Quality Management System.
Ensure ongoing regulatory compliance of all policies, processes, equipment, products and deliverables.
Track quality related commitments made through CAPA system and provide updates to management.
Evaluate current processes and recommend improvements with the goals of increased efficiency, improved product/service quality, process automation, and regulatory compliance.
Establish, implement and manage PHT?s audit program including internal audits, supplier audits and client audits. Support preparation for and conduct of audits by regulatory authorities, clients and third parties, coordinate response and track on going commitments.
Periodically update management on all quality system and compliance issues. Conduct formal periodic reviews of the quality system with management.
Act as PHT?s Quality System Management Representative for all ISO 9001:2008 related issues.
Review and approve validation packages for PHT?s Core Product and eStudy design and delivery projects where necessary. Provide direction and recommendation throughout the development life cycle.
Oversee all quality system follow-up including responses to clients, audits and other inspections
Maintain understanding of all current issues and changes in US and international GxP regulatory compliance activities.
Manage the overall quality department budget including training and/or similar for employees to remain current in all US and international GxP regulations and guidance.
Oversee PHT?s Document Management Process and System, and provide expertise to associates working on quality system documents.
Design and implement a supplier management system that includes auditing, corrective actions and periodic assessment of issues that affect PHT quality.
Create an overall corporate training program that includes not only training on relevant SOPs in support of ISO registration, but also includes job related training, periodic corporate regulatory training and effectiveness measures.
Required Skills and Experience:
A minimum of 7 years experience in Pharmaceutical or biotechnology industry with at least 5 years of experience in leading role as Quality Assurance of computer systems and/or software
Experience with interpretation and practical application of US and international GxP regulations, procedures and guidelines that govern quality systems, development and delivery of software and services for clinical trial investigations
Training and certification as a quality auditor or equivalent work related experience
Lead experience implementing and maintaining a quality system in a regulated environment
Experience with ISO 9000 standards and implementation
Strong writing, presentation, and general communication skills
Project management experience
Strong organizational and administrative skills
Ability to handle a variety of tasks and juggle multiple assignments
Ability to travel to domestic and international locations.
||Boston, MA |
THIS JOB HAS EXPIRED