Associate Director, QA Bioanalytical
Celerion is the premier provider of innovative early clinical research solutions. Partnering with us means working with one of the most experienced CROs in the world. Celerion is derived from the Latin celeritas meaning swiftness and speed. Our name reflects our founding principle - to help our clients get their products to the market faster.
Celerion’s focus is on the implementation of innovative strategies to generate key data very early to enable go/no-go decisions on drug development. With clinic capacity of more than 730 beds (24 in-hospital), efficient bioanalytical laboratories and experienced scientific staff, Celerion offers one of the most experienced clinical pharmacology research networks in the industry.
We have an exciting opportunity for an Associate Director, Quality Assurance-Bioanalytical located at our Corporate Headquarters in Lincoln, NE.
Oversee, lead and provide direction to the bioanalytical quality assurance team. Interface with regulatory authorities and/or clients. Provide direction and training to bioanalytical operations staff for regulatory compliance. Respond to regulatory authorities/agencies as required.
• 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
Experience and Qualifications
• 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, please visit our online hiring center at www.celerion.com
MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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