Role: Commercial Quality Specialist
Location: Dublin
Reports to: Commercial Quality Lead
Closing Date: 8th November
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, 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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to build a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver significant solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
Purpose
Responsible for carrying out Commercial Quality activities to support the organization in developing and maintaining an effective Quality Management System (QMS) for the UK /Ireland Local Operating Company (LOC) & Johnson & Johnson Managed Service (JJMS) QMS where applicable. Including quality support for the Ireland warehouse.
Responsibilities

• Ensure compliance to all applicable quality standards & regulatory requirements in the UK/Ireland LOCs, JJMS and associated Distribution Centers. Both external and J&J.
• Own, track and conduct non-conformances and CAPA investigations and document in the appropriate systems using approved tools.
• Ensure compliance in the Ireland warehouse to the applicable J&J procedures & standards
• Establish and implement corrective & preventive actions to mitigate potential or remediate actual non-conformances
• Embed QMS principles in the organization & drive continuous improvement
• Work to the requirements of European and national Medical Device, Medicinal Product and Human Tissue legislation where applicable.
• Ability to work alone but part of a virtual team. Work independently to resolve quality issues locally or where applicable with appropriate escalation
• Support site audits (e.g. from regulatory bodies, corporate audit teams etc.)
• Manage and support Quality System elements for the Johnson & Johnson Managed Service QMS as appropriate
• Manage & lead change control activities as applicable
• Manage/implement the Supplier/Distributor/POLO approval and monitoring program including supplier audits, as applicable

Qualifications

Requirements

• B.Sc. in a Life Science or Engineering subject preferred
• Experience in a primarily quality role within a high regulated environment (preferably Pharmaceutical or Medical Device) with knowledge of healthcare regulations
• Experience of working with competent authorities and other regulators - preferred
• Excellent written and oral English communication skills
• Good collaboration skills and ability to work independently with internal partners
• Demonstrate Leadership behaviours expected by J&J Credo and Leadership Principals
• Good System & Computer knowledge (Excel, Word, Power Point, Outlook, J&J systems)
• Customer focus for both internal and external customers. Ability to develop close relationships with customers and colleagues at all levels.
• Integrity and Credo-based Actions - The ability to build trust. The willingness to put the Credo top of mind for all decisions.
• Results and Performance Driven
• The ability to deliver business results and solutions and keep the focus on driving customer value.
• The willingness to assume personal ownership and accountability.
• Collaboration and Teaming
• The ability to work well across functions and groups and to build effective teams.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.