Associate Director, Global Quality Compliance - Microbiology 9/7/2016

A New Beginning - Genesis 2 Forest Park, IL

Company
A New Beginning - Genesis 2
Job Classification
Full Time
Company Ref #
27974372
AJE Ref #
576112464
Location
Forest Park, IL
Job Type
Regular

JOB DESCRIPTION

APPLY
ASSOCIATE DIRECTOR, GLOBAL QUALITY COMPLIANCE - MICROBIOLOGY

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.

ADDITION RESPONSIBILITIES:

* 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.

QUALIFICATIONS

* 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.

COMPENSATION
Base Salary - $130, to $150,
Benefits - Full
Bonus Eligible - Yes
CANDIDATE DETAILS
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.

In all cases we always have several jobs not yet published on the WWW, listed on linkedin or posted to our company website.

Many full job descriptions and base salaries in your field of experience can be viewed in various sections on -

A New Beginning-Genesis 2