Job Description :
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
The Director of Laboratory Management, Microbiology will be responsible for standardizing laboratory methods and processes across 50+ manufacturing sites globally. This position will focus on all microbiology good manufacturing laboratory practices and will standardize practices across all facilities to ensure that we are in compliance as well leading the industry in best demonstrated practices.
This new position will have responsibility for identifying resources that harmonize and contemplate the appropriate balance between outsourcing, centralizing and insourcing of methods. He or she will facilitate the transfer of chemistry, microbiology and engineering methods from Research & Development or other sources to Operations. As the gatekeeper for all product quality-related methods, and their associated change controls, this individual will drive standardization of equipment, instrumentation, metrics, reporting, validation and related information technology systems. As the global leader for standardization of laboratory methods and process, he or she will be responsible for lab inspections and inspection readiness.Essential Duties and Responsibilities
- Serving as the lead quality laboratory operations representative specializing in microbiology worldwide to implement harmonized manufacturing operations across Baxter labs
- Develop innovative methods that will lead the industry in microbiology laboratory management
- Developing and executing quality assurance, continuous improvement, regulatory strategies and programs under a GMP and GLP environments
- Developing streamlined processes and risk management programs for quality functions
- Participating in company's strategic planning process and develop the company's quality management goals with different functional leaders
- Provide guidance to lead competent authority and Notified Body meetings
- Communicating quality reports to VP of Laboratory Management and the VP of Quality
Education and Experience
- Experience in biological, chemical, microbiological and engineering methods
- Knowledge of Method Validation guidelines, GLPs, GMPs, FDA, ISO, MDD regulations
- Experience with FDA and other MOH inspections
- Talent management experience of coaching and developing laboratory managers in a matrixed environment
- Ability to influence internally and externally
- Demonstrated ability to standardize the way people use the data (interpret the grey areas) to ensure avoidance of committing alpha or beta errors
- Experience and ability to implement the right metrics to measur performance (operations, financials, etc.)
- Experience with turning around an organization and sustaining the results - developing a plan and achieving results over an extended period of time
- Preference for candidates with a 6 Sigma Black Belt Certification
- Sense of urgency, ability to navigate barriers and influence people
- Highly motivated with excellent written and verbal communication skills and strong analytical and leadership skills
- BS in a scientific or engineering discipline and an advanced degree (MS, PhD) is required
- Minimum of 10 years' experience in managing teams within a matrix organization and laboratory GLP/GMP management with increasing scope including global responsibility and quality assurance in multiple companies
- 7 years management experience
#LI-BB1-P Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.
A little about us:
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.