Spectrum Pharmaceuticals, Inc.
Cambridge, MA, United States
Manager, Quality, Pharmaceutical
The Sr. Manager of Clinical Quality Assurance will manage compliance related to Good Clinical Practices (GCP’s) and Good Laboratory Practices (GLP’s). This position will be responsible for partnering with the internal Clinical Operations Organization to ensure compliance to all aspects of operations. This position will support all Clinical Quality Assurance functions such as Quality Events Reporting, Corrective Actions and Preventative Actions and Quality Clinical Investigation site audits.
Organizational Support Responsibilities
: Directly Interface with Clinical Operations to address any operational and/or compliance issues. Will be responsible for ensuring all issues be document in the internal quality management system. Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
Prepares, conducts and reports investigator site and document audits that encompass Phase I through IV studies of clinical development; supports lead auditor during vendor and system audits to ensure compliance with applicable regulations, GCP guidelines, and company quality standards; enters data and supports the maintenance of the audit management database, distributes and files audit information; Perform QC of audit reporting and tracking documentation.
: Able to identify, address, and document clinical quality events.
Corrective and Preventative Action (CAPA) Tracking and Communication Responsibilities:
Generates CAPA plan requests, audits related correspondence and memos. Maintains QA tracking logs including tracking of CAPA commitments arising from any source.
Supports the facilitation of all GCP regulatory inspections (internally); Assists in the preparation, coordination, and tracking of document requests, responses, and other supporting documentation during inspections; tracks responses and remediation activity.
Consultation and Training:
Supports and documents consulting and training of internal teams on quality standards and procedures; Supplies audit information and procedural training materials to Clinical Team Members; Supports the department with research of industry best practices, regulatory requirements, guidance, and standards.
Skills, Education and Experience:
BA/BS in Health Sciences or related field preferred.
A minimum of 5 years of industry experience, which must include 3 yrs of Clinical QA exp.
Previous clinical monitoring experience is required.
Demonstrates a thorough knowledge of GCP regulations and guidelines.
Excellent written and oral communication skills and interpersonal skills.
Ability to effectively manage multiple projects.
Must be available to work in the evenings and weekends, as required
Position Location and/or Territory and Travel
Position is located in Irvine, CA or Boston
Position will require up to 30% travel.
Spectrum Pharmaceuticals, Inc.
Website : http://www.spectrumpharm.com