Johnson & Johnson Careers

Senior QA Manager

Cork, Ireland
Quality Assurance


Job Description

Requisition ID: 1905736422W

_work
We focus on change. We use innovation to prevent, treat, cure and stop diseases. Developing a vaccine for HIV, refrigerated drones that deliver medicines to places that are hard to reach or robots that operate, everything we do should have a positive impact on people’s lives, nearby and worldwide. 

_live
We take care of our people. We give them the chance to discover, engage, live life to the fullest. We hand you the tools to customize your work life to your own lifestyle. With enough fun and challenges at work but also enough time for you.

_grow
As a young professional, you want to grow. We want you to grow. We offer an international context, filled with opportunities and programs to broaden your knowhow and experience, 
in-depth or beyond. 

Janssen Pharmaceutical Sciences Unlimited Company has been manufacturing bulk active pharmaceutical ingredients in Cork since 1981. Products are sold throughout the world to other Janssen and third party companies, where they are further processed into tablets, creams, or injectable dosage forms. These finished products are used in the treatment of a range of Psychiatric, Gastro Intestinal and Fungal disorders 
as well as in the treatment of HIV.

LOCATION
Little Island, Cork, Ireland

JOB TITLE
Senior Quality Assurance Manager 

Job description

This position is responsible for managing Quality related programs and activities to support the site and manufacturing operations.  These functions and activities include Quality Assurance, Compliance activities, Product Release activities.

Key job responsibilities:
Responsible for appropriately staffing and developing the Quality organization to meet business needs and succession plans.  
Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
Ensure harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems.  
Ensures financial leadership by developing appropriate operating and capital expense budgets
Supports Quality performance excellence and metrics program.  
Quality responsibility for complex chemical processing operations, including large scale Aseptic (Sterile) manufacturing process for Invega Sustenna. 
Analyzes regulatory authorities’ programs and activities in areas relevant to products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
Encourages, supports and directs initiatives and programs that lead to improved quality and improved regulatory compliance.
Mentors and coaches’ staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel.

Recommendations for both sections: 
Gives strategic direction to the Quality groups in the execution of their duties.
Coordinates the activities of the groups within quality to create a synergistic approach to goals and tasks.
Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.
Participates in the overall collective leadership by the senior management team at the site.


Qualifications
Qualifications
Education & experience
Recommendations:
Advanced degree required in a scientific or engineering discipline
5-10 years’ experience in a significant leadership position within the pharmaceutical industry.
5 years’ experience in a quality leadership role
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals. 


Primary Location
Ireland-Cork-Cork-
Organization
Janssen Pharmaceutical Ltd. (8170)
Job Function
Quality Assurance
Requisition ID
1905736422W