Manager EQ SM Drug Substance EMEA

About the vacancy

Quality Quality Control Quality Assurance Compliance R&D Small molecules Engineering Chemical Manufacturing Quality

Manager EQ SM Drug Substance EMEA for Small Molecules Drug Substance external manufacturers in EMEA region.

• Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes.
• Contributes to the overall development, implementation, and execution of quality systems in support of the commercial production of JJIM products(small molecule drug substance) at external manufacturers. Ensures proactive and continuous compliance with applicable Health Authority regulations and J&J standards, including effective risk management.
• Conducts investigations, performs audits, collects data, analyzes trends, and prepares reports as required. Escalates issues as appropriate to Senior Management and supports the Management Reviews.
• Works closely with internal functions (PES, MSAT, EHS, and Procurement etc.), other Quality Assurance functions and external manufacturers.

Define key accountabilities and/or activities:

Pursues the high standards of quality and compliance. Consistently makes Credo based decisions and coaches others to take actions that prioritize customer, patient, and employee needs.

Provides leadership and ensures the success of external manufacturer qualification and monitoring, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. Provides balanced management of quality and compliance risks with business needs.

Effectuates and permanently maintains inspection readiness at the external manufacturers, including on site representation during regulatory inspections and audits. And drives development of corrective actions plans, as needed.

Responsible and accountable for the quality and reliability of products produced at the external manufacturer. Coordinates and executes the EQ Management activities. This includes continuous oversight and management of:

• Quality activities during manufacturing and quality control (including validations, issue management, trouble shooting, change management, supplier, and material management).
• Execution of monitoring and auditing activities (including creation of quality agreements)
• Assessing quality systems and recommending improvements in order to enhance quality
• Reporting of quality activities, and as needed escalation of issues to senior JSC management

Grow:

Develops self and others to reach their goals. Engages in open and honest conversations. Drives performance by managing energy and taking ownership for outcomes.

With focus on Quality activities, develops and fosters an environment of innovative thinking and learning at the external manufacturer, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress.

Assists the external manufacturer in defining Quality Strategies and Organizational Development.

Coordinates or executes quality activities in support of New product Introduction (through upscaling and launch), process improvements and significant changes.

Shape:

Inspires and contributes ideas that challenge thinking. Courageously tries new things, tests and learns from mistakes. Demonstrates resilience and agility to drive and adapt to change.

Contributes and shares more good experience/practices and contribute by participating into more projects in the team, SM platform, and EQ organization etc.

Works with business partners and external manufacturer to ensure alignment of supplier qualification/monitoring activities with strategic business direction.

Ensures that the quality process and systems to support JJIM product manufacturing are adhered to and maintained. Communicates expertise and guidance on relevant regulations, directives, J&J standards, and industry guidance related to quality systems design and operation.

Defines and monitors adherence to metrics for Quality with the external manufacturer. And looks for improvement opportunities.

Connect:

Builds internal and external relationships based on…