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.
Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
Professional
Responsibilities
* 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.
Key Accountabilities & Activities
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.
Grow
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.
Shape
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.
Connect
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 Qualification
* 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 small molecule drug substance (small molecule API, late intermediate, registered starting material), knowledge of small molecule drug substance synthesis process, quality management/mannufacturing required.
* Experience in external manufacturing, technology transfers, quality event management, and quality system development required. Experience presenting issues to all levels of the organization required.
* Ability to manage quality systems and provide cGMP compliance support to external manufacturers required, including proven ability to manage regulatory inspections and Health Authority exposure.
* Demonstrated experience with small molecule API manufacturing and quality control preferred. Includes understanding of typical unit operations, process equipment, and analytical techniques (HPLC, GC, IR, wet chemistry testing, etc.).
* Demonstrated experience with quality activities during small molecule API process development, upscaling, validation, and launch preferred. Includes understanding of filing requirements and regulatory support.
* Proficiency in computer applications such as the MS Office suite preferred.
* Interpersonal skills required to build long‑term relationships, influence up and down, negotiate acceptable outcomes, and work in multiple disciplinary, cross‑cultural environments in external manufacturers and J&J.
* Demonstrates refined skills in the following global leadership areas: integrity and credo‑based actions; strategic thinking; big picture orientation with attention to detail; intellectual curiosity; collaboration and teaming; sense of urgency; prudent risk‑taking; self‑awareness and adaptability; results and performance driven. Ability to travel a minimum of 40% required. Position will be based in different countries, but business trips will be required regionally within EMEA and globally when needed. Very frequent on‑site presence at external manufacturers required.
* Fluent in English.
Other Requirements
* Team collaboration skills and coaching skills. Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style.
* Strategic thinking capabilities and ability to translate strategy to execution.
* Results‑driven leader who commits to stretch goals and delivers results. Sound business skills, balanced decision maker.
* Ability to build relationships and confidence with suppliers who support J&J.
* Demonstrated understanding of regulatory requirements that impact quality systems specifically, and external manufacturers and JSC more broadly.
* Ability to balance multiple tasks, objectives, and priorities.
* Problem‑solving abilities and issue resolution abilities within regulatory constraints.
* Risk management abilities.
Required Skills
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