Locations: Geel, Antwerp, Belgium; Latina, Italy; Leiden, Netherlands; Schaffhausen, Switzerland.
Manager EQ SM Drug Substance EMEA for Small Molecules Drug Substance
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.
Responsibilities
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, troubleshooting, 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.
Live Our Credo & Pursue Our Purpose
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.
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 contributes by participating into more projects in the team, SM platform, and EQ organization. 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 respect. Seeks, listens to, and incorporates diverse points of view. Collaborates openly across boundaries and acts as a team player. Lead frequent interactions with external manufacturers, up to and including Sr. Management levels, for the purpose of driving reliability, continuous improvement, Risk management, Quality strategies and Quality System compliance. Partners with internal functions (PES, MSAT, EHS, and Procurement etc) 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. Remaining 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/Pharmacy/Pharmaceutical/Chemistry/Technical/Synthesis Process technology/Chemical Engineering. Advanced degree (MS, MBA) is 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/manufacturing is a must.
Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development, and presenting issues to all levels of the organization.
Ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers, including proven ability to manage Regulatory inspections and Health Authority exposure.
Demonstrated experience with small molecule API manufacturing and Quality control is preferred. Including 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 is preferred, including understanding of filing requirements and regulatory support.
Proficiency in computer applications such as the MS Office suite.
Interpersonal skills to build long term relationships, influence up and down, negotiate acceptable outcomes, 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% is 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 will be 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.
Preferred Skills
Business Alignment
Coaching
Collaborating
Compliance Management
Continuous Improvement
Fact-Based Decision Making
Good Manufacturing Practices (GMP)
ISO 9001
Process Improvements
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Quality Validation
Regulatory Environment
Standard Operating Procedure (SOP)
Tactical Thinking
Technical Credibility
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