Associate Director, Global Quality Compliance - Microbiology 9/8/2016
Lake Forest, IL
JOB DESCRIPTIONAPPLY 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, filter validation, and sanitization agent validation. This position will lead and integrate initiatives that drive the highest microbiology standards across multiple functions. This position ensures alignment with evolving corporate and global laboratory standards, quality system 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 quality system re-deployment, site level remediation.
Collaborate with senior leadership team in meeting corporate goals
* PhD degree (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 TravelRequired.
* 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.