Commercial Quality Senior Manager

Biopharma Asia; Ciudad de México; Hybrid; MXN 1,200,000 - 1,800,000; Full time

Job summary

Johnson & Johnson in Mexico City seeks a Sr Manager Commercial Quality Cluster EP/NV to lead the regional quality management framework for LatAm. You will drive CAPA, regulatory alignment, and cross-functional quality initiatives across countries, ensuring QMS effectiveness and compliance with local regulations.

You will collaborate with regional leadership, manage audits, and drive process excellence to deliver world-class quality and patient safety across the cluster.

Qualifications

• Experience leading quality programs and QMS in a multi-country environment.
• Strong knowledge of CAPA, risk management and data-driven decision making.
• Familiarity with ISO 9001 and regulatory expectations in healthcare.

Responsibilities

• Lead the Cluster Commercial Quality organization and QA activities across LatAm.
• Develop strategic measures and targets for quality performance.
• Manage CAPA and risk management processes for the cluster.

Skills

Quality Management

CAPA

Regulatory Compliance

Leadership

Cross-functional Collaboration

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Brazil R-107197, Chile R-108692, Colombia R-108693, Mexico R-108694

Remember, 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:

Mexico City, Mexico

Job Description:

Overall purpose of job:

Under the general direction of the Commercial Quality Senior Director, this position is responsible for establishing and leading Johnson & Johnson 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 ManagerCommercial 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.

Required Skills:

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