Director of Compliance

Where

Pearl River, NY

What you'll be doing

This position will be responsible for develop, implement, oversee and maintain compliance inspection and audit readiness plans in collaboration with key partners. Provide project management expertise to successfully develop and implement plans that ensure compliance with quality processes, procedural documentation. Oversee all aspects of managing and implementing compliance of personnel with the execution of compliance training initiatives. Provide progress updates, including summarization of key audit findings and audit resolution, to leadership. Responsible for coordinating responses to deficiencies found on audits by identifying root causes of the deficiencies, developing and implementing corrective actions, and modifying SOPs to prevent recurrence of deviations and/or deficiencies found on an audit. Identify the subject matter experts (SMEs) to assist in the development and implementation of standard operating procedures (SOPs) and/or implementation guidelines as relate to company research. Identify minimal SOP requirements for contractors, ensure mechanisms and training are in place. Monitor and track colleague and contractor curriculums and training. Lead contact, interface and responsible person for functional area site, lab and vendor qualification audits working with the quality assurance organization.

What your background should be

Proven experience in a clinical compliance position required. Able to priority setting, technical learning, problem solving, managing through systems. Strong knowledge of and experience with ICH, FDA, EMEA and GLP/GCP/GMPs, clinical processes, project/process management, facilitation management, training design and development, industry enterprise systems, MS Office applications and a solid understanding and use of relational databases. Ability to multi-task and prioritize assignments. Strong communication (written and verbal), facilitation and presentation skills.

Required Schooling / Training

Bachelor of arts/bachelor of science degree with 11+ years in pharmaceutical, regulatory, quality assurance or health care fields and master of art/master of science degree with 9+ years in pharmaceutical, regulatory, quality assurance or health care fields.

Who is the client company

It is an American multinational pharmaceutical corporation.

If you are interested in this position, send your resume to apply@kochdavis.com