About the Role
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements: Brazil R-107197, Chile R-108692, Colombia R-108693, Mexico R-108694. Whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category: People Leader
All Job Posting Locations: Bogotá, Distrito Capital, Colombia; Las Condes, Santiago, Region Metropolitana de Santiago, Chile; Mexico City, Mexico; São Paulo, Brazil
Overall Purpose of Job
Under the general direction of the Commercial Quality Senior Director, this position is responsible for establishing and leading Johnson & Johnson's overall quality management framework and quality system for the cluster, establishing preventive and corrective actions to mitigate potential or actual non-compliance risks and ensuring compliance to attain world-class operational/customer focused capabilities.
The overall management responsibilities also require exerting leadership in regional projects and initiatives providing strategic direction to achieve established goals. Role complexity includes but is not limited to ability to interact cross segment and representation of the region in global projects and initiatives.
The Sr Manager Commercial Quality Cluster EP/NV is responsible for leading activities towards the integration of the quality management systems for applicable country(ies). This position is responsible for ensuring the QMS requirements are effectively executed in the markets in accordance with local regulations, corporate and segment policies and procedures.
The scope of this role is applicable to the Commercial Quality operations in all clusters from LatAm (Brazil/Southern Cluster, Mexico/Northern Cluster).
Essential Duties and Responsibilities
•Lead the Cluster Commercial Quality organization, including all commercial activities, and support to handling, storage, distribution (when applicable), to ensure a proactive approach to quality assurance and quality systems.
•Develop appropriate strategic and process performance measures/targets.
•Manage the overall corrective and preventive action (CAPA) and risk management processes.
•Establish and maintain global and local relationships with partnering organizations and regulatory bodies.
•Oversee the management of Standard Operating Procedures, ensuring simplicity, standardization and education across the countries.
•Operate as a key business partner for quality and process improvement, understand business requirements.
•Ensure compliance to all applicable quality standards and regulatory requirements.
•Ensure troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
•Present case studies and metrics to Cluster Leadership.
•Coordinate execution of internal audit, and 2nd party audit as needed.
•Lead the management review process for the cluster as Management Representative. Propose initiatives for quality performance improvement.
•Drive complaint vigilance execution in the countries ensuring the timely reporting and closure of product related complaints cases, quality, and immediate escalation.
•Understand current requirements of Regulatory Agencies such as local MOH's, as well as standard organizations such as ISO.
•Ensure compliance with the J&J policies and local regulations at the local warehouses and distributors.
•Effectively work with Cross Segment leadership (functional and commercial) in the deployment and sustainability of initiatives that will support QMS execution and compliance on designated countries.
•Management of Pharmacovigilance and Post Market Surveillance (Technovigilance) systems within the cluster.
Strategy and Planning
•Develop a common vision and strategy for Quality and Process Improvement.
•Entrench a process improvement culture within the business. Implement process management practices, verify/validate project results and advocate further use of PE to drive business results.
•Embed QMS management principles in the organization, creating cross-functional process improvement teams who effectively complete improvement projects central to these efforts.
•Engage all company employees in these initiatives, through interactive project coaching/consulting and change management strategies.
•Develop appropriate strategic and process performance measures/targets.
•Ability to represent the region in Global and Regional forums, leading functional efforts as required to achieve results.
Relationship Management
•Partner with the Cluster, Surgery Commercial Quality and Deliver (for Handling Storage and Distribution), Regional and Functional Community, Business Leaders, Process Owners and Project Teams.
•Work with external business partners and regulators to build capability and ensure compliance to quality standards.
•Strengthen quality & compliance capability in the organization, through tools like training, newsletters, conferences, quality week.
Job Requirements
•Professional degree: Bachelor's or Master's degree in Business, Biosciences, Engineering or equivalent field, Chemistry, Pharmacy, or health-related discipline.
•Advanced English, Spanish and Portuguese is a plus.
•Experience: Minimum 5 years of relevant quality leadership role of which a minimum of 3 years in pharmaceutical, medical device, or healthcare industry.
•Commercial & Supply Chain knowledge.
•Auditing experience.
•Proven track record of leading or coaching teams to achieve significant quality and process improvements.
•Ability to negotiate and influence at various levels in the organization.
•Strong communicator.
•Experience with project management and statistical software.
•Relevant experience in the healthcare or pharmaceutical industry.
•Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.
Preferred Skills: Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team Management
