Sr Mgr EQ Small Molecule, Drug Substance

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. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Allschwil, Basel-Country, Switzerland, Geel, Antwerp, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Little Island, Cork, Ireland, Madrid, Spain

Job Description:

Sr.

Manager EQ Small Molecules, Drug Substance

Essential Job Duties and Responsibilities:

This position provides Quality Assurance, Compliance and Technical Support for Small Molecules Drug Substance external manufacturers in EMEA region.

Provides QA support for 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 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.

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, trouble shooting, change management, supplier, ...