Regional Quality Director LATAM

hace 4 semanas

Ciudad de México, Ciudad de México Bayer A tiempo completo

About this role

As Regional Quality Director LATAM at Bayer, you will be responsible for providing Quality Leadership and Senior Accountability to the Consumer Health Division LATAM Region.

Your responsibilities will include:

  • Adopting and implementing the Divisional and Regional Strategy and Quality plan for a large and complex region.
  • Accountability for the Compliance to GMP, Regulatory and Internal Bayer standards and Quality performance of large sites to ensure the continued manufacture and supply of Global brands generating over €590 million/year in Net Revenue.
  • Leadership of a large Quality team (approx. 300 people) responsible for internal manufacturing and CMO management.
  • Quality performance of 3 critical internal manufacturing sites and over 20 external CMOs with a wide range of product dosage forms and regulatory classifications.
  • Provide agility, initiative, and a solution focus to the business through a highly complex cultural and Regulatory landscape operating in over 30 countries and supporting approx. 950 product licences.
  • Provide Senior leadership and decision making on Quality and business events as the point of accountability for the Consumer Healthcare division in the region.
  • Significant interaction and communication to Senior stakeholders within the region across multiple functions and levels of the business on Quality performance for the region.
  • Key Senior Leader within the Bayer Consumer Health Global Quality Leadership team creating and driving Divisional Quality Vision, Strategy, and performance.
  • Senior Leader within the Regional Product Supply leadership team, creating and driving strategies for business and operational priorities.
  • Provides both leadership and direct management of the Quality teams responsible for internal manufacturing sites and CMO management.
  • Partnership with key stakeholders (such as Product Supply, Regulatory, Commercial, R&D) on creating and driving a regional Quality strategy and advantage for the region that compliments the overall business strategy.
  • The implementation and performance of Bayer Quality KPIs and QMS performance across the region.
  • Supporting the communication and interaction with multiple Health Authorities across a complex Regulatory landscape.
  • Quality resource is in place across the region to ensure Regulatory compliance across all activities. This includes Health Authority and other external inspections of manufacturing sites and external partners alongside the identification and implementation of CAPA.
  • Senior Quality decision maker for Critical Quality Issues occurring within the region.
  • Ownership of regional succession planning for the Quality group that ensures the development and retention of talent and feeds into the global succession plan.
  • Accountable for continuous improvement and performance of product release cycle times across the region including QC testing and QA batch release activities.
  • Management and stakeholder alignment of a significant annual budget for Quality across the teams and sites within the region.
  • Review and stakeholder alignment of the regional Quality investment plan to drive compliance to regulations and the continuous improvement of Quality standards and performance.
  • Senior Leadership – the ability to guide and inspire teams towards a common goal whilst building a culture of transparency, inclusivity, and trust.
  • Coaching – developing talents within the team, identifying strengths and opportunities in individuals, and developing plans to support their career goals.
  • Clear and effective communication – adapting technical topics into a simple messaging for a variety of different stakeholders with a focus on business context.
  • Dealing with complexity – the ability to navigate, deal with political sensitivity and prioritise in a complex matrix organisation at a range of levels.
  • Decision making and stakeholder management – interpretation and simplification of information, political agility (internal and external) and stakeholder management across multiple functions and countries to find solutions that balance Regulatory compliance with business priorities.

About you

We are looking for a highly experienced Quality professional with a strong track record of delivering quality leadership and senior accountability in a complex region.

Qualifications

  • A degree in the life sciences of pharmacy with at least 10 years of experience in Quality Assurance Management. Experience in Quality Operational (manufacturing) is mandatory for this role.
  • Experience across international Quality standards (cGMP, GDP, ISO) and Health Authorities interaction is desired.
  • Highly experienced in QMS maintenance and governance, performance, and compliance KPIs and effective management reviews.
  • The ability to develop fit for purpose organisational structures in a cost-effective manner.
  • Management of large headcounts and financial budgets.

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