Commercial Quality Director Canada

4 semanas atrás

São Paulo, São Paulo, Brasil Abbott Laboratories Tempo inteiro
About Abbott Laboratories

Abbott Laboratories is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott Laboratories

At Abbott Laboratories, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Benefits to provide you and your family the necessary support for good wellbeing (i.e. health plan, pension plan, employee support programs, among others).
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity

This position works out of our São Paulo - Michigan office location in the Diabetes Care business (ADC). We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

As Commercial Quality Director for Canada and LATAM (CALA), you'll have the chance to manage the CALA Commercial QA and Affiliate QA teams and ensure compliance in respective processes across Commercial Affiliates for ADC. You will be responsible for managing, mentoring and supporting a QA team to ensure the consistency of commercial quality related decisions in CALA, operating according to Abbott policies and procedures, following local regulations and guidelines, international Industry and Quality System Standards, and will operate as a single point of contact for all quality related issues between Division Quality and Commercial organizations.

Key Responsibilities
  • Oversee and/or support internal ADC Affiliate audits including preparation of Corporate/Divisional Audits at Affiliates.
  • Ensure Quality System awareness and compliance in CALA:
    • Utilize audit input for the Implementation of CAPAs and improvements.
    • Promote and support trainings/QS facilitation to the ADC organization on Quality System requirements.
    • Maintain and/or develop QS compliance and effectiveness at Commercial Affiliates in collaboration with Subject Matter Experts (SME) and identify potential QS improvements for relevant QS elements or processes.
  • Support CALA and global Improvement Programs of ADC and OneAbbott.
  • Sustain a professional cooperation with other Abbott Divisions in respect to maintaining and/or developing a shared QS (e.g. Shared Services, OneAbbott).
  • Partner with the Commercial Management for CALA & Regions to support effective business operations and programs while maintaining compliance with policies, procedures and legal and regulatory requirements.
  • Maintain cross departmental relationships with the ADC Quality Organization (e.g. CQA/CHG/SQA etc..) as well as other Operations Functional Units of relevance (e.g. Logistics, Regulatory Affairs) in order to provide direct support and communication between those functional units and CALA Commercial Management.
  • Hire team staff as necessary, conduct annual performance reviews and set objectives in line with ADC Goals.
  • Build a team with high expertise to support the CALA area and ensure talent development within the team in their positions or for future responsibilities.
  • Establish a culture of teamwork, innovation and continuous improvement and high collaboration across the QA organization and with the commercial business operations in CALA Area.
  • Develop experts to support the QS for CALA or global Improvement Programs.
  • Develop team talent and ensure that knowledge and experience acquired is transferred to other team members.
Requirements
  • University/College Degree in Natural/Life Sciences, Technical Engineering, Medical or Quality Management (i.e. Bachelors or equivalent).
  • Other education may be acceptable in case of a relevant combination of education and experience, e.g. for Process or Quality-Management or closely related discipline (e.g. Medical Devices, Diagnostic or Pharmaceutical Industry) for five or more years in a comparable position.
  • Preferrably, a minimum of 5 years of experience in the Medical Devices, Diagnostic or Pharmaceutical Industry, Competent Authority, related Industry Association or equivalent.
  • Proven strong knowledge of medical device standards, such as ISO 13485, ISO 9001, or Pharmaceutical Regulations, etc. and a high degree of responsibility and ownership for ensuring the highest level for QA.
  • Influencing Management and strong Leadership Competencies together with a long experience related to working in an international environment/cross-functional team and/or executive.

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