Associate Director, Global Quality Compliance - Microbiology

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

A New Beginning - Genesis 2 Forest Park, IL

Forest Park, IL
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Full Time
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This position will provide technical and strategic stewardship, mentorship, and oversight of Microbiology programs employed at our company's India Manufacturing site. The role involves use of risk-based approaches to define and assess microbial controls for existing processes and new installations. Responsibilities will include developing and implementing targeted process improvements, as well as strategic-level transformations to the site microbiology department.

Oversight will include the integrated aspects of site microbiology programs including:

* aseptic process simulations,
* cleaning / sanitization programs,
* aseptic manipulation / intervention programs,
* sterility assurance risk assessment strategies,
* discard strategies, f
* ilter validation, and
* sanitization agent validation.

This position will:

* Lead and integrate initiatives that drive the highest microbiology standards across multiple functions.
* Ensure alignment with evolving corporate and global laboratory standards, qualitysystem element remediation, regulatory inspection information, external benchmarking and best practices resulting in robust inspection readiness and alignment.
* Direct the development, planning, implementation and maintenance of Microbiology test methods, processes and operations.
* Develop strategies and actions to continuously improve data management practices, test method reliability 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.
* Ensure laboratory compliance with regulatory guidance, corporate standards and internal SOPs.


* Serve as the Corporate SME for Microbiology.
* In collaboration with the Senior Director participates in strategic initiatives and corporate activities to include qualitysystem re-deployment, site level remediation.
* Collaborate with senior leadership team in meeting corporate goals.


* PhDdegree (preferred) in Microbiology or other relevant Life Science discipline with a minimum of 10+ year pharmaceutical/biotech experience, or a BS with 15+ years or an MS 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
* Prior experiences in managing microbiology and aseptic manufacturing processes are preferred.
* Knowledge of pharmaceutical microbiology including assay validation, regulatory interactions and cGMP is essential.
* Experience in microbial techniques such as LAL, Bioburden, Growth Promotion, TOC, etc.
* Experience managing an environmental qualification program.
* Experience in project management.
* Working Knowledge of applicable cGMP regulations (21CFR 211, EU GMP, PIC/s GMP, USP,EP, ICH)
* Computer skills with utilization of Microsoft Office (Outlook, Word, and Excel) are required.
* Effective time management and organizational skills
* 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, to $150,
Benefits - Full
Bonus Eligible - Yes
10+ to 15 years experience
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel - Often
Location: Field (Home) Based - relocate in 1 - 2years to ILL, NJ or NY ST

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.

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A New Beginning-Genesis 2