Manager EQ SM Drug Substance EMEA – Small Molecules Drug Substance
Johnson & Johnson Innovative Medicine believes 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. Learn more at https://www.jnj.com .
Job Description
Manager EQ SM Drug Substance EMEA for Small Molecules Drug Substance external manufacturers in 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 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.
Define Key Accountabilities And/or Activities
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.
Provides leadership and ensures the success of external manufacturer qualification and monitoring, with an emphasis on 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 the external manufacturers, including on site representation during regulatory inspections and audits. And drives development of corrective actions plans, as needed.
Responsibilities
Quality activities during manufacturing and quality control (including validations, issue management, trouble shooting, 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.
Minimum Qualification
Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry / Technical / Synthesis Process technology / Chemical Engineering Required. Advanced degree (MS, MBA) is preferred.
Minimum 6-9 years' experience in Pharmaceutical cGMP environment is required.
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 is required. Experience in presenting issues to all levels of the organization is required.
Ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers is required. Including proven ability to manage Regulatory inspections and Heath 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 is preferred.
Interpersonal skills are required 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.
Required Skills
Not specified.
Preferred Skills
Not specified.
Seniority Level
Not Applicable
Employment Type
Full-time
Job Function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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