Johnson & Johnson Careers

BUSINESS QUALITY SPECIALIST

Bogotá, Colombia
Quality Assurance


Job Description

Requisition ID: 1905762455W

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. We touch the lives of over a billion people every single day.
Johnson & Johnson Medical Companies produce a broad range of creative products and solutions used primarily by health care professionals in the fields of orthopedics, neurological disease, infection prevention, cardiovascular disease, and aesthetics. As the most comprehensive devices business in the world, J&J Medical Devices is the best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands.
Are you ready to impact the world?
If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

Description of the role:

The Business Quality Specialist is responsible for Internal Audit Program, Supplier & Distributor Audits and the Quality System Inspection Readiness activities. Ensure the compliance with J&J policies and procedures described in the Quality Management System applicable to the Marketing Company and the distribution channels and requirements indicated by Local Quality Regulations.

Essential duties and Responsibilities

  1. Performs internal audits as lead auditor to ensure compliance with all applicable regulations and Johnson & Johnson standards.
  2. Conducts Supplier & Distributor audits and support the Cross Sector Supplier/Distributor Audit Program executing the assigned audits
  3. Maintains Inspection Readiness processes to ensure the Quality Management System is maintained in a state of readiness to applicable regulations and local Health Authorities requirements.
  4. Coordinates cluster preparations for external audits and inspections.
  5. Support development of responses to address external audit and inspections results.
  6. Responsible for reporting, tracking and timely closure of audit (internal, supplier, distributor & external) applicable corrective and preventive actions.
  7. Alert management of quality & compliance issues for proper and timely escalation to Regional and Franchise Management and to Management Review.
  8. Performs & reports compliance metrics and drive improvement on those metrics.
  9. Ensure results of monitoring process are routinely communicated to management through the Region Management Review process.
  10. Serves on cross region project teams consistent with company goals and objectives to improve overall compliance & quality system performance to established metrics and requirements.
  11. Ensure results of monitoring process are routinely communicated to management through the Region Management Review process.
  12. Alert management of quality & compliance issues for proper and timely escalation to Regional and Franchise Management and to Management Review.
  13. Perform other work-related duties as assigned by the Business Quality Senior Manager.
  14. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.


Qualifications

Qualifications:

  • A Bachelor's degree is required. A degree in science, engineering, or related field is preferred.
  • Proficiency in the Microsoft Office suite of products is required.
  • Bilingual (English-Spanish, read,write and speak)
Required
  • A minimum of 5 years experience working in a regulated environment.
  • Strong regulatory compliance experience
  • Experience with internal/ external audits
Desirable
  • Medical Device and Pharmaceutical manufacturing experience is strongly preferred, experience with Biologic and Cold Chain products will be a differentiation for this position.
  • Current Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and/or lead auditor certification is strongly preferred.

Competencies:

  • Attention to details
  • Good communication skills in English and Spanish or Portuguese
  • Strong written and verbal communication skills.
  • Planning & Organization skills
  • Management of Complexity
  • Prioritization skills
  • Results Oriented
  • Ability to dedicatedly identify improvement opportunities.
  • Ability to manage multiple priorities and deliver excellent results
  • Dedicated teammate, able to take charge and follow-through.
  • Strong teaming and collaboration skills

GLP Competencies

  • Collaboration and Teaming
  • Big Picture Orientation with Attention to Detail
  • Results & Performance Driven
  • Sense of Urgency

Leadership Imperatives Competencies:

  • Connect: Develop deep insights into the needs of our patients, costumers, markets and communities.
  • Lead: Build an environment where leadership and talent development are top priority.
  • Deliver: Deliver results by inspiring and mobilizing people and teams.
  • Shape: Drive innovation; anticipate and craft industry and market changes to advance health care globally.
  • Credo: Demonstrate and inspire the behaviors that reinforce our Credo
  1. Integrity and behavior based on the Creed: acts according to the values of the Creed; generates confidence; tells the truth; Print transparency to problems; It shows genuine concern for people.
  2. Global orientation with attention to detail: can operate in two "worlds" simultaneously, p. eg, growth and cost control, success of the ventures and the local company; see why and what happens; You can put yourself in perspective and get close to things, as needed.
  3. Collaboration and teamwork: puts the interests of the company above their own; works well in different functions and groups; build equipment efficiently; inspire followers; infuses a global mentality.
  4. Sense of urgency: perceives and responds dedicatedly to problems and opportunities; works to reduce the "cycle" time; It comes into action when it is needed.
  5. Prudence in taking risks: internal confidence to take risks and learn from experiences; courage to take advantage of opportunities or get rid of non-viable businesses.
  6. Self-awareness and adaptability: with capacity for recovery; Modest and humble; willing to learn from others; patient; optimistic, flexible and adaptable.
  7. Flexibility and Adaptation to Change: Open to learning, is in continuous personal improvement, is aware of itself and the impact it generates on others, is receptive to feedback, is flexible, adapts to characteristics that demand different situations.
  8. Intellectual curiosity: Challenge to the status quo and search for creative solutions that can improve the way of doing things. see the possibilities; willing to experiment; pursue new ideas; pleasant with ambiguity and uncertainty.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Want to be part of something great?

Don't forget to apply. We want you!

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Primary Location
Colombia-Distrito Capital de Bogotá-Bogotá-
Organization
Johnson & Johnson de Colombia S.A. (7755)
Job Function
Quality Assurance
Requisition ID
1905762455W