Associate Director, Global Quality Compliance - Data Governance

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POST DATE 9/7/2016
END DATE 12/19/2016

A New Beginning - Genesis 2 Lake Forest, IL

Lake Forest, IL
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Full Time
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JOB DESCRIPTION This position will provide technical and strategic stewardship, mentorship, and oversight of Data Governance, Reliability, and Integrity programs employed at the company's India Manufacturing site. This position provides guidance and technical expertise to site staff in managing and coordinating the implementation and development of data standards, data governance and a data quality framework model. The position will be responsible for the implementation and oversight of data management goals, standards, policies, practices, and processes. This role will drive the creation of a data governance program and lead the implementation of an effective data governance operating model. The main objective is aligning people, process, policy, and technology to ensure data is secure, accessible, and trusted.


* Develop and implement targeted process improvements, as well as strategic-level transformations to the site's data governance programs.
* Responsible for ensuring industry data standards are appropriately utilized and leveraged to drive data quality and compliance and to ensure impact is minimized, mitigated appropriately and relevant regulatory obligations are met .
* Ensures alignment with evolving corporate standards, qualitysystem element remediation, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment.
* Develop strategies and actions to continuously improve data management practices and repeatability assuring inspection readiness.
* Assess and enhance site level SOPs and corporate level policy documents.
* Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessment.


* Serve as the Corporate SME for Data Governance.
* In collaboration with the Senior Director, participates in strategic initiatives and corporate activities to include qualitysystem re-deployment, site level remediation.
* 75%International TravelRequired, especially to India, some Europe. These positions involve remediation of the India site. Field (home) Based, remote; relocate in 1 - 2 years to ILL, NJ or NY ST

M.S. degree (preferred) in a relevant Life Science discipline with a minimum of 10+ year pharmaceutical/biotech experience, or a BS with 12+ years of pharmaceutical/biotech experienced based on the required skill set.
75% International Travel Required, especially to India, some Europe. These positions involve remediation of the India site. Field (home) Based, remote; relocate in 1 - 2 years to ILL, NJ or NY ST
Firm knowledge of Six Sigma tools, Certified Black Belt (preferred).
Working Knowledge of applicable cGMP regulations (21CFR 211, EU GMP, PIC/s GMP, USP,EP, NF, ICH).
Computer skills with utilization of TrackWise and Microsoft Office (Outlook, Word, and Excel) are required.
Proven ability to interpret data by performing trend analysis.
Proven ability in technical writing skills.
Effective time management and organizational skills.
Experience in project management.
Strong attention to detail and cross functional teams experience.
Strong leadership skills, ability to drive accountability, compliance and efficiency throughout the department.
Highly creative, able to conceive and develop ideas to successful laboratory implementation.
Skilled at team motivation and people development.
Demonstrated excellent written and verbal communication skills.

Base Salary - $130,000 to $150,000
Benefits - Full
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes
10+ to 15 years experience
Minimum Education - Master's Degree
Willingness to Travel - Often

Also, please understand this may take time for both of us working together to help advance your career. I will do my best for you and never charge you anything for our time and efforts.