SQAFYI - Software QA Resource - FYI

US-Lincoln-Nebraska: Sr. Manager/Associate Director, QA Bioanalytical

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 06-Dec-2012

Responsible for QA staff management in accordance with the organization's procedures/policies and all applicable regulations/laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning , performing and directing QA work/audits; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees. Provide technical and regulatory guidance to QA and operational staff Develop training programs and oversee the training of new employees both within QA and bioanalytical operations in regards to regulatory compliance Interface with clients and other departments to ensure needs and deadlines are being met Assist in the development and implementation of department policies and procedures Actively participate in quality management systems and drive continuous process improvement Develop metrics to identify opportunities for improvement Participate in departmental budget preparation and administration Coordinate and facilitate Regulatory Authority inspections Assure management that records, methods and practices are in compliance with company policies/ procedures and regulatory requirements Complete, review , issue and resolve audit findings/observations to/with operational management

BA or BS in Science or related field required Knowledge of FDA, ICH and other regulatory authority regulations, guidelines and requirements Minimum of 5 years experience in CRO and/or Pharma Quality Assurance in positions of increasing responsibility required. Excellent level of GLP and GCP knowledge required Ability to organize and manage multiple priorities Excellent oral and written communication skills Minimum of 3 years management experience required

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US-Lincoln-Nebraska: Sr. Manager/Associate Director, QA Bioanalytical