Senior Manager, Statistical Methodologies Job at Olympus Corporation of the Americas
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Job Description
The Senior Manager, Statistical Methodologies will apply their leadership and experience in the application of statistical methods to support Olympus’ Manufacturing Quality organization. This role will work closely with Olympus’ global manufacturing network to provide technical statistical expertise.
Job Duties
- Responsible for developing and delivering GMP utilities, equipment and process validation programs to ensure compliance with applicable cGMPs and global health authority regulations.
Partners with Manufacturing, Quality, Regulatory and IT to develop validation plans and ensure their execution and lifecycle management.
Develop and share validation expertise and scientific understanding of key Manufacturing Operations. Is a subject matter expert in validation approaches (e.g., Facility, Utility, Equipment, Process & Computer System validation, risk-based approaches etc.) and apply this understanding to ensure Product Supply manufacturing operations are maintained in a constant state of compliance.
Develops best in class validation programs for process/facilities/utilities and equipment.
Support products throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification).
Drive and monitor project plans for validation activities and ensure plans are delivered.
Provides guidance, expertise and oversight for site validation of facilities/utilities, equipment and technologies.
Job Requirements
REQUIRED QUALIFICATIONS:
Bachelors, Masters, or Ph.D. in statistics, or similar field with elements of statistics.
Minimum of 10 years of statistical experience.
Experience in the application of statistical methods in at least two of the following areas: mixed effects models, linear and nonlinear modeling, statistical intervals, experimental design, statistical process control, and sampling plans.
Expert user of at least one GUI statistical package (JMP or Minitab).
High-level expertise in statistical programming in at least one language (SAS or R).
Track record of successful project leadership and delivery within a matrix organization.
Will work with global teams, availability will include working across the associated time zones. International and domestic travel up to 15% of the time.
PREFERRED QUALIFICATIONS:
Excellent communication skills and relationship-building with customers.
Skills: Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator, Quality Engineering Disciplines, Quality Control Disciplines, Quality Systems Disciplines and Strategic Leadership.
** The anticipated compensation range for this position is $109,000 to $152,000 USD annually and the compensation offered will depend on the candidate’s qualifications.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||
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