Description

This position is primarily answerable for driving and overseeing all quality assurance aspects relating product and quality systems. the top of Quality can develop and supply strategic direction within the implementation of GxP quality methods, policies, procedures, and best infrastructures to confirm compliance of development activities to applicable laws. whereas this position needs a good vary of quality skills to foresee department and company wants because the organization and therefore the surroundings changes, the top of Quality can have a selected stress on GCP quality assurance.

Responsibilities

Ensure product, procedures and practices meet company goals and quality and restrictive standards. Actively acquire data on dynamical laws and practices that relate to operations
Prepare for and lead GxP compliance audits, as well as PAIs.
Provide experience and steering in deciphering government laws and tips as they apply to product and practices.
Establish cooperative relationships with vendors, CROs, CMOs, and affiliate organizations to enhance overall quality.
Drive the employment of methods, technologies, resources and processes in support of quality initiatives.
Ensure Company policies square measure in line with the company QA Policies and objectives.
Establish department goals and objectives, guaranteeing they support company goals and objectives.
Establish department performance and quality indicators. Track and trend individual and department performance and create enhancements and changes as needed.
Develop, coaches and trains personnel to confirm that a compliance culture is made into every day operations
Work with Finance and senior management to develop, track and manage division budgets. give feedback on department and budget prices as required to effectively use resources.

Qualifications

BS or MS in life sciences. Minimum 15 years

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