Manager EQ SM Drug Substance EMEA

Job Title:

Manager EQ SM Drug Substance EMEA at Johnson & Johnson Innovative Medicine

Locations:
Beerse, Antwerp, Belgium;
Geel, Antwerp, Belgium;
Latina, Italy;
Little Island, Cork, Ireland;
Madrid, Spain;
Schaffhausen, Switzerland;
Zug, Switzerland.

Job Description:

Provide QA support for small‑molecule drug substance technology transfers and improvement of existing manufacturing processes at external manufacturers in the EMEA region. Contribute to the development, implementation, and execution of quality systems in support of the commercial production of JJM products (small‑molecule drug substance) at external manufacturers. Ensure proactive and continuous compliance with applicable health‑authority regulations and J&J standards, including effective risk management.

Key responsibilities include:

Managing quality and reliability of products produced at external manufacturers, coordinating and executing EQ Management activities, and ensuring continuous oversight and management of quality activities during manufacturing and quality control.

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

• Bachelor’s degree in science, pharmaceutical, pharmacy, chemistry, technical, synthesis process technology, or chemical engineering. Advanced degree (MS, MBA) is preferred.
• 6–9 years’ experience in a pharmaceutical cGMP environment.
• Experience with small‑molecule drug substance (API, late intermediate, registered starting material); knowledge of synthesis process and quality manufacturing is required.
• Experience in external manufacturing, technology transfers, quality event management, and quality system development.
• Capacity to manage regulatory inspections and Health Authority exposure.
• Proficiency in computer applications such as the MS Office suite.
• Interpersonal skills to build long‑term relationships, influence, negotiate, and navigate cross‑cultural environments.
• Demonstrated leadership skills (integrity, strategic thinking, collaboration, urgency, risk‑taking, adaptability, results‑driven).
• Minimum 40 % travel required.
• Fluent in English.

• Excellent written and verbal communication skills, teamwork, coaching, and strategic thinking.
• Results‑driven leader who commits to stretch goals and delivers outcomes.
• Ability to build confidence with suppliers and balance multiple priorities.
• Strong problem‑solving, issue resolution, and risk‑management abilities.

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