Senior Quality Manager PHT
THIS JOB HAS EXPIRED Position Responsibilities:
The Senior Quality Manager primarily serves two important functions in the Quality Department:
As a lead representative for PHT in hosting client audits of PHT under the procedures outlined in PHT?s Quality Management System.
Supporting clients who are undergoing regulatory inspections of completed trials in which PHT systems have been used.
As a Senior Quality Manager you will also:
Review PHT products, systems, deliverables and documentation for:
Conformance to regulatory requirements and applicable guidance worldwide
Escalation of issues pertaining to privacy, data integrity, security and performance problems for investigation and documentation of corrective and preventive action.
Develop, maintain, and report:
System performance measures and metrics
Incidence of defects, audit findings and rates of occurrence and closure of outstanding issues.
Review process documentation for compliance to SOP?s and applicable regulations such as:
Guidance and management of process and product improvement projects
Review and resolution of QMS defects and CAPA Plans
Coordinate and direct contractors and other Quality Department staff to ensure coverage and successful conduct of internal audits, external audits and inspections.
Under the direction of Quality Management, conduct audits of internal systems, tools, and functions as well as external suppliers for compliance with PHT?s Standard Operating Procedures and external Regulations. Such audits include but not limited to:
Clinical Trial development, implementation, and archive
Core software products
Internal software tools
Following the execution of the audit, the Senior Quality Manager will:
Track and report quality concerns and problems to PHT Management
Participate in audit follow up, and Corrective Action procedures
Act as a resource to PHT staff and management
Function as the primary contact point for client auditing of our quality systems.
Planning and preparation of audits
Developing actions plans and follow-up
Hosting of client auditors
Support Sales and Marketing in developing RFI and RFP concerning regulatory policy and conformance by PHT
Maintaining the supplier management program, including documented risk assessment and recommendations for the extent of PHT?s audit program for suppliers and partners.
Auditing of supplier operations
Education Minimum: BA, BS or equivalent work experience
Required Skills and Experience:
2-5 years experience in quality systems management, including training and experience with clinical trials and auditing
Knowledge of GCP and international Quality/Regulatory Rules, Standards, Guidelines
Able to write clearly and to follow written procedures accurately
Strong communication and partnering skills are musts
High integrity and transparency concerning discovery and disclosure of issues
Works well both independently and as a team player
Computer literacy and familiarity with most common software applications such as Microsoft Office applications
||Boston, MA |
THIS JOB HAS EXPIRED