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
http://sqa.fyicenter.com