Manager EQ SM Drug Substance EMEA
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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.
Job Overview
Manager EQ SM Drug Substance 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. Contributes to the overall development, implementation, and execution of quality systems in support of the commercial production of J&J IM products at external manufacturers, ensuring proactive and continuous compliance with applicable health authority regulations and J&J standards, including effective risk management.
Key Responsibilities
Responsible and accountable for the quality and reliability of products produced at the external manufacturer. Coordinates and executes the EQ Management activities, including continuous oversight and management of quality activities during manufacturing and quality control (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.
Works closely with internal functions (PES, MSAT, EHS, Procurement, etc.) and other QA functions as well as external manufacturers.
Maintains inspection readiness at external manufacturers, represents on site during regulatory inspections and audits, and drives development of corrective action plans.
Supports new product introduction, process improvements, and significant change initiatives at the external manufacturer.
Builds and maintains internal and external relationships, collaborates across boundaries, and communicates the status of external manufacturers to support management review processes.
Keeps current with local, regional, and global health authority regulations, guidelines, and quality practices related to cGMP and API manufacturing.
Minimum Qualifications
Bachelor's degree in Science/Pharmaceutical/Pharmacy/Chemistry/Technical/Synthesis Process Technology/Chemical Engineering (advanced degree preferred).
6–9 years of experience in a pharmaceutical cGMP environment.
Experience with small‐molecule drug substance (API, late intermediate, registered starting material) synthesis, quality management, and manufacturing.
Experience in external manufacturing, technology transfers, quality event management, and quality system development.
Proven ability to manage regulatory inspections and health authority exposure.
Strong understanding of small‐molecule API manufacturing, analytical techniques (HPLC, GC, IR, wet chemistry), and unit operations.
Experience with process development, up‐scaling, validation, and launch of small‐molecule APIs, including regulatory support.
Proficiency in Microsoft Office suite.
Excellent interpersonal, negotiation, and cross‐cultural communication skills.
Demonstrated global leadership skills: integrity, strategic thinking, collaboration, urgency, risk‐taking, self‐awareness, and performance orientation.
Willingness to travel at least 40 %, including frequent on‐site visits to external manufacturers within EMEA and globally as required.
Fluent in English.
Other Requirements
Team collaboration and coaching skills.
Strategic thinking and ability to translate strategy into execution.
Results‐driven leadership with balanced decision making.
Ability to build relationships and confidence with suppliers.
Knowledge of regulatory requirements impacting QA systems and external manufacturers.
Strong problem‐solving and issue resolution skills within regulatory constraints.
Risk management capabilities.
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