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IMEx and Human Error Reduction Manager

Pfizer


Location:
Kalamazoo, MI
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

**ROLE SUMMARY**



This position will have two primary areas of focus: IMEx implementation into Quality Operations and building a robust Human Error Reduction Program in the Laboratories.







**IMEx Implementation:**







+ QC Ecosystem Full Scale Deployment requires "Champions" to enable implementation of IMEx holistically throughout the labs



+ Provide direct help with CI Loop and TPM modules to ensure successful implementation and continuous improvement including Belt Project support



+ After QC implementation is complete will aid in other IMEx roll outs within the Quality Organization in Kalamazoo **Human Error Reduction Program:**







+ Greater than ~1800 Deviations (QARs/ERs/LIRs/RAACs) per year in the Lab are due to Human Error



+ Initially provides capability to address high volume Human Error deviations reactively by building the program and then transitions to proactive elements such as situational awareness and other deviation prevention tools



+ Ensures alignment with PGS Strategy of Deviation Reduction across the network







**ROLE RESPONSIBILITIES**







+ **IMEx:**



+ Supports all QC IMEx implementations throughout the Kalamazoo Laboratories



+ Provides direct help with CI Loop and TPM modules to ensure successful implementation and continuous improvement including Belt Project support



+ After QC implementation is complete, will aid in other IMEx roll outs within the Quality Organization in Kalamazoo



+ **Human Error Reduction:**



+ Develop and Drive implementation of human error reduction initiatives in the QC Laboratories



+ Initially provides capability to address high volume Human Error deviations reactively by building the program



+ Transitions to proactive elements such as situational awareness and other deviation prevention tools



+ Ensure consistent approach to human error reduction across lab organization



+ Serves as a Human error reduction subject matter expert representing the labs in addition to teaching and mentoring others in key PHP Investigative Principles



+ **Additional Responsibilities:**



+ The successful candidate will effectively champion belt projects (green or black belt) for the labs in an effort to significantly reduce deviations and non value added activities in the labs



+ The successful candidate will regularly attend the Site Zero Defect Steering Team meeting to represent the labs and share Zero Defect initiative improvements on a quarterly basis



+ The successful candidate will be a change agent who is dedicated to driving positive change through their work.



+ The successful candidate will support our Zero Defects culture through advocating the use of Method 1 and PHP methodologies in day to day activities.



+ The incumbent will coach/facilitate project teams, assist in Deviation Initiative strategy definition, solve problems, and implement solutions to improve operational performance.



+ This role includes the responsibility of providing strategic proposals, progress updates and presentations to all levels of the site organization, including Center functions as applicable







**QUALIFICATIONS**







+ **Education:**



+ BS, MS, or PhD in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science



+ **Experience/Certification:**



+ Minimum of 5 years of experience in a cGMP environment with a strong working knowledge of a variety of quality systems and processes



+ The candidate must have demonstrated proficiency in organizational and project management skills, strong problem solving and continuous improvement abilities, and must be able to balance multiple priorities



+ The candidate must be trained in and demonstrated successful usage of Method 1 and Pfizer Human Performance tools



+ The candidate must be a certified Green or Black belt



+ The candidate should have experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigations, investigation techniques (Ex. Method 1, Human Error Reduction, Six Sigma, 5 Whys, etc...), operational excellence, lot release, product and process validation, laboratory testing, or quality assurance.



+ **Communication:** Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies







**EEO & Employment Eligibility**



Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Additional Offer Details:**







+ **Last Date to Apply for Job: December 4, 2017**



+ **This job is Pfizer/Exempt/US/ Grade: 10**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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