Manager Quality Assurance and Regulatory Compliance
Synowledge
Mysore
1d ago
source :

Provides support to leadership within Quality Assurance and Regulatory Compliance for corporate standards integration efforts ongoing projects issue escalation and resolution and quality improvement initiatives throughout Bioclinica to ensure that outcomes meet or exceed company policies industry standards customer expectations and regulatory requirements The role provides consulting input to internal and external stakeholders as well as ongoing and retrospective oversight Primary Responsibilities Provides support to leadership for corporate quality improvement initiatives Conducts internal and external audits in support of corporate initiatives and external consultant opportunities Provides support during sponsor audits and regulatory agency inspections Champions process and tool improvements to facilitate comprehensive data and metrics collection projects within Quality Assurance and Regulatory Compliance Provide support to corporate compliance activities and teams Provides support to leadership and champions Bioclinica s Quality Assurance and Regulatory Compliance standards Provides support to leaderships in ongoing process improvement process standardization and integration efforts that evolve Bioclinica s Quality Management System QMS Provides QA and Regulatory consultation on systems development policies and procedures as well as resource planning and staff development Oversees and directs compliance reviews and internal auditing programs Implements continuous improvement activities to ensure ongoing compliance with the changing regulatory environment Mentors and provides guidance to departments on implementing and maintaining compliant processes and software validation best practices Actively support and or participates in management committees and special projects to ensure quality and compliance are built into the company s activities Champions Bioclinica s Quality Manual and associated documentation Collaborates with stakeholders in the development of operational training materials and development programs Supports the implementation and improvement of the corporate performance management program Supports the design development and implementation of effective Quality Management Systems for Bioclinica s CorporateWide Secondary Responsibilities Maintains Quality Service and Departmental Standards by Reading understanding and adhering to organizational Standard Operating Procedures SOP Assisting in establishing and enforcing departmental standards Contributes to team effort by Working with internal staff to resolve issues Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by Attending and participating in applicable company sponsored training Perform supervisory functions by Communicating Job expectations Planning monitoring and appraising job results Mentoring counselling and disciplining staff Identifying and developing key staff to eventually assume greater responsibility and growth within the company Performing timely performance evaluation of direct reports Qualifications Education BA BS or equivalent plus extensive knowledge training and expertise from job experience preferred Experience 10 years of experience within Life science industry Sound knowledge of clinical research environments Sound knowledge of GxP regulations and guidelines Quality inspection auditing and testing experience 5 years management experience in quality assurance and quality systems 5 years of experience in computer validation processes in regulated environment including 21 CFR Part 11 Annex 11 Japan ER ES Additional skill set Excellent verbal and written communication skills Excellent documentation and organizational skills Excellent analytical skills and the ability to work independently Leadership skills and personal qualities to be successful within a matrix organization Working conditions Travel 10 35 Lifting 0 10 lbs Other Computer work for long periods of time

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