Manager EQ SM Drug Substance EMEA

Manager EQ SM Drug Substance EMEA for Small Molecules Drug Substance

External manufacturers in the EMEA region. Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes.

Quality

Quality Assurance

Professional

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

Live Our Credo & Pursue Our

Purpose:

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

Provides leadership and ensures the success of external manufacturer qualification and monitoring, emphasizing 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 external manufacturers, including on‑site representation during regulatory inspections and audits, and drives development of corrective action plans as needed.

Develops self and others to reach 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, 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.

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

Contributes and shares good experiences/practices and participates in more projects in the team, SM platform, and EQ organization. Works with business partners and external manufacturer to align 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 seeks improvement opportunities.

Builds internal and external relationships based on respect. Seeks, listens to, and incorporates diverse points of view. Collaborates openly across boundaries and acts as a team player.

Leads frequent interactions with external manufacturers, up to and including senior management levels, to drive reliability, continuous improvement, risk management, quality strategies, and quality system compliance.

Partners with internal functions (PES, MSAT, EHS, and Procurement) and business partners to effectively manage external manufacturers, including participation in top‑to‑top meetings and supplier business review meetings.

Communicates external manufacturer status to support management review processes. Remains current with local, regional, and global Health Authority regulations, guidelines, and quality practices associated with cGMP and API manufacturing.

• Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry/Technical/Synthesis Process Technology/Chemical Engineering. Advanced degree (MS, MBA) preferred.
• Minimum 6‑9 years’ experience in a pharmaceutical cGMP environment.
• Experience in…