Commercial Quality Specialist

Commercial Quality Specialist

Location: Dublin

Working mode: Hybrid, 2 days on-site and 3 days WFH

Duration: 6 months (opportunity for contract extension)

Hours: 37 hours per week

Pay rate range: Competitive hourly rate

Travel: Limited travel to other offices/suppliers as required

Imagine your next project as a Commercial Quality Specialist. The successful candidate will be 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

roles and responsibilities

• Ensure compliance to all applicable quality standards & regulatory requirements in the UK/Ireland LOCs, JJMS and associated Distribution Centres. 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

Other:

• Promote a proactive compliance driven culture of quality based on the 5 quality principles

• Demonstrate Leadership behaviours expected by J&J Credo and Leadership Principals

• Ensure working to quality requirements at all time to ensure internal and external Quality compliance – be audit ready at all times

• Ensure timely and consistent escalation of events

• Create inputs for management review process and quality planning

• Lead and/or participate in quality/compliance/regulatory projects

• Manage/implement the Training Program, as applicable

how to succeed

Essential Knowledge and Skills:

• 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

Core competencies required for this role:

• 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, PowerPoint, Outlook and ideally 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

• The ability to deliver business results and solutions and keep the focus on driving customer value

• The willingness to assume personal ownership and accountability

• The ability to work well across functions and groups and to build effective teams

• The willingness to put interests of enterprise above own

• Positive attitude, well organized with attention to details

• Have a sense of urgency

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months and has a strong chance of extension.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.