Senior Manager QA Products Parenterals

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:
People Leader

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

Johnson and Johnson Innovative Medicine (Cilag AG) is recruiting for a Senior Manager QA Products Parenterals (Value Optimizer and Late Stage), located in Schaffhausen, Switzerland.

The function holder is managing a team of Quality Product Owners (Local Quality Owners), reports to the Director QA Parenterals and is part of the QA Parenterals Leadership team.

The position holder is responsible for all Quality & Compliance aspects of high-value parenteral products in regards of manufacturing and packaging.

Prime Objective is to ensure that products comply with applicable standards and have been manufactured, tested and released according to cGMP.

This includes a wide range of products in pre-filled syringes and vials, including some of the largest brands of Johnson & Johnson Innovative Medicine.

Key Responsibilities:



* Ensure that Quality standards are reliably maintained and comply with J&J global guidelines and regulatory expectations and provide quality and compliance guidance and leadership for a large portfolio of parenteral products.


* Assessment of criticality, initiation of investigations, assessment of the investigation results and defined corrective actions, close out of investigations and tracking of corrective actions.


* Review and approval of GMP relevant documentation, initiate quality escalations and lead escalation meetings, ensure permanent inspection readiness state and act as lead in J&J internal and external regulatory inspections.


* Lead the Local Quality Owner team including driving talent development, conduct performance reviews and ensuring sufficient and appropriately trained QA resources within QA Products Parenterals.

Qualifications

Education:


* University degree at a master level in relevant discipline, e.g.

biosciences, pharmacy, analytical chemistry, process technology or engineering.

Experience and Skills:

Required:


* A minimum of 5 years experience in quality functions in pharmaceutical or medical device companies including people leadership responsibility.


* In-depth knowledge of current Quality Management principles, GMP and Quality Systems and Pharmaceutical regulations (PIC/S, ICH, FDA guidelines, Eudralex, etc.)


* Excellent written and oral communication skills in German and...