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Director of Quality

Req # JR - 024506 Location Jayuya, Municipio de Jayuya, Puerto Rico Additional Locations 40 Job Category Quality Control Date posted 07/21/2020

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SUMMARY:

Plans, coordinates, represent and direct quality program designed to ensure continuous production of products consistent with established standards.  Organizes and strategies the quality management activities at the Plant, such as: process approval and product approval, implementation of all FDA requirements, budget activities.  Assure that Baxter complies with all internal and external standards and regulations (FDA, applicable ISO standards, OSHA, EPA). Appointed as the Quality Management Representative of the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Formulates and maintains quality objectives complementary to corporate policies and goals.
  • Interprets quality philosophy to key personnel in organization.
  • Coordinates objectives with production procedures in cooperation with other plant managers and corporate managers to maximize product reliability and minimize costs.
  • Applies total quality management tools and approaches to analytical and reporting processes within each department.
  • Directs departments engaged in inspection and testing activities to ensure continuous control over materials, processes, facilities, and products.
  • Plays active role on quality management teams within organization
  • Designs and implements quality training programs to key personnel in conjunction with corporate and other managers.
  • Plans, directs, organizes and focuses resources in the following key areas: process control, process validation, critical system qualification, product release, product testing, documentation flow and review, product transfers, regulatory agency inspections (Example:  FDA), internal audits and inspections.
  • Ensures the promotion of awareness of customer requirements throughout the organization.
  • Evaluates and approves regulatory submissions (FDA, MOH, TÜV, etc.).
  • Approves and evaluates budgets to quality managers.
  • Plans, develops and implements organization policies and goals.
  • Coordinates activities of quality departments such as: validations, operations, and documentation.
  • Analyzes department budget requests and allocates operating budget.
  • Drives the team to achieve the proposed goal in compliance to all internal and external regulations and standards.
  • Responsible to support all quality area associates, assuring a teamwork environment.
  • Represents Quality Area in house and outside the Plant (e.g. internal and external audits, Corporate meetings).
  • Able to work with many projects and handle multiple tasks at the same time.
  • Able to work Holidays, extra hours, or any shift when required (e.g. shutdowns, external audits -FDA, ISO 9001), Corporate-, special projects)
  • Willing to travel.
  • Should be able to work with minimum supervision.

SUPERVISORY RESPONSIBILITIES:

Manages multiple subordinate managers who supervise employees in the Quality Assessment, Operation Quality Management and Validation and Critical Systems.  Is responsible for the overall direction, coordination, and evaluation of these units.  Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS:

  • Bachelor's degree (B.S.); Master Degree preferred; eight to ten years of previous experience in related industries; excellent communication skills; computer literate
  • Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations. 
  • Ability to write reports, business correspondence, and procedure manuals. 
  • Ability to effectively present information and respond to questions from groups of: managers, customers, internal and external audits.  
  • Fully bilingual (English and Spanish languages).
  • Ability to work with mathematical concepts such as statistics and apply as to practical situations.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • cGMP's trainings and other trainings, certificates or license that immediate supervisor refers.
  • Observe and promote company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company.  Should report any violation.

PHYSICAL DEMANDS 

While performing the duties of this job, the incumbent is regularly required to sit and talk or hear.  The incumbent is frequently required to use hands to finger, handle, or feel.  The employee is occasionally required to stand, walk, and reach with hands and arms.  The incumbent must occasionally lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision and color vision.

WORK ENVIRONMENT

While performing the duties of this job, the incumbent is occasionally exposed to wet and/or humid conditions, moving mechanical parts, extreme cold, and extreme heat. 

EQUIPMENT and/or SAFETY EQUIPMENT

The incumbent is required to use the appropriate Safety Equipment that Baxter requires to comply with all Safety and Security rules (in Regulated Areas), such as: safety glasses, safety shoes, uniform, special safety suit, gloves, and any other safety equipment necessary in order to protect the health and safety of the incumbent. While performing the duties of this job, the incumbent is required to use the appropriate equipment such as: computer, calculator, telephone, fax machine, copy machine, and office supply.

DISCLAIMER STATEMENT

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

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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.

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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 e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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