Site Head of Quality - Cork

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/.

Main Responsibilities:

This position is responsible for leading and managing all Quality related programmes and activities to support the site and manufacturing operations.

These functions and activities include Quality Control testing, Quality Assurance review and approval functions, Compliance activities, Product Release activities, etc.

Reporting Relationships:

The Site Head of Quality reports to the Vice President Supply Chain Quality, Large Molecule.

The following roles report to the Senior Director of Quality Janssen Sciences Ireland (JSI): QC Director, QA Manager, QS Manager, Senior Scientist, Microbiology.

Main duties and 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.


* Partners with other Janssen Supply Chain (JSC) Site Quality Heads and Headquarters Quality head to ensure harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems.


* Functions in a leadership role on the Site Leadership Team, lead by the Site General Manager for site operations.


* Ensures financial leadership by developing appropriate operating and capital expense budgets and strives to have the Quality organization contribute to Cost of Goods Sold (COGS) improvement.


* Supports Quality PE and Metrics Program.


* Provide leadership to direct reports and JSC through:
+ Develops and champions an organizational culture that promotes behaviors that lead to superior business performance and organisational excellence.
+ Creates a commitment to customer service.
+ Engages in proactive relationships with the local/regional/national regulatory authority.
+ Analyzes regulatory authorities programs and activities in areas relevant to biological 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.
+ Manages and guides staff and those involved in quality activities to achieve the best results.
+ Mentors and coaches staff, as well as develops and implements training programs, to ensure professional and personal devel...