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J&J Family of Companies QC Manager Quality Control Lab Services in Cork, Ireland

QC Manager Quality Control Lab Services - 2406199424W

Description

As part of the Johnson & Johnson family of companies, Our Purpose is ‘We blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.’ We are guided by the values in Our Credo. With responsibility to patients, employees, communities, and stakeholders, Our Credo puts the needs of each of those first.

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 in Ireland 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”.

Janssen Sciences Ireland, Ringaskiddy, Cork

Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100-acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, pioneering monoclonal antibody technology, a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis. In 2017, we announced the investment of more than €300 million in the expansion of our manufacturing plant with the creation of more than 200 new jobs, and we are in the midst of continued expansion.

What is it like to work at Johnson and Johnson Innovative Medicine, Ringaskiddy, Cork

  • Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose. In 2016, we were the first biopharmaceutical manufacturing company in Ireland to receive the Business Working Responsibly Mark.

  • Strategically, as a global centre of excellence for clinical trial drug substance, drug product release, and stability management, in 2020 our adoption of Fourth Industrial Revolution (4IR) technologies was recognized by the World Economic Forum as a ‘Lighthouse’, the first biopharmaceutical in Ireland to be included in the world’s 54 most advanced facilities. We are also building capabilities needed for the workforce of the future: digital, change leadership, and critical thinking & problem solving.

  • From a People perspective, we invest in our people, and take great pride in providing a positive work environment which respects diversity, supports wellbeing, and embraces innovation. This is empowered through our Talent Council in which both managers and individual contributors drive employee development and university engagement, and employee resource groups (ERGs) focused on further balances of gender, nationality, capability and more, including the additional attracting of qualified diverse candidates for our open roles.

Job Summary:

The QC Manager Laboratory Services is responsible for the execution of all activities under the remit of the Lab Services Team. This is a diverse multi functionary group which provides key services to JSC QC and BTDS AD such as:

  • Laboratory equipment and software Lifecycle mgmt. activities

  • Data integrity and CSV for Laboratory software and equipment

  • Capacity, performance Mgmt., Scheduling & procurement.

  • The implementation of the QC Digital Journey.

The Manager of Laboratory services will play a key role within the QC Leadership Team and will also participate as an integral part of the Johnson and Johnson Innovative Medicine Large Molecule Quality (LMQ) Laboratory framework.

Qualifications

What you’re great at:

  • A leader with a passion for developing your team.

  • Practicing Servant Leadership by facilitating and empowering the individual teams to deliver services, projects or initiatives per agreed delivery timelines.

  • Ability to clearly communicate whilst ensuring understanding.

  • Developing and setting measurable and results-oriented goals.

  • Ability to adapt to any situation and be decisive.

  • Excellent interpersonal skills with a clear collaborative approach.

  • Strategic thinking

  • Ability to operate as part of a team and influence a team is critical.

  • Proven track record in quality risk management and GMP requirements

  • Customer focus

  • Innovative

  • Keeping up to date with the regulatory, technical developments in the industry that will affect products on-site

  • Always maintaining a focus on patients and customers

  • Maintaining the highest standards of ethical behavior

The responsibilities and the impact YOU will have:

  • Identifying opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc.

  • Planning and delivery the QC digital journey

  • Propose and agree the functional goals for the area and providing timely routine reports to laboratory and quality management to demonstrate the current performance of the area.

  • Anticipate and plan for future requirements in the area, including such aspects as procedural requirements, capital planning, personnel recruitment planning, compliance requirements, efficiency developments and anticipated changes needed to reflect future demand for services.

  • Ensuring systems are in place to assure QC activities are carried out in compliance with product license commitments, cGMP and company Quality standards and guidelines.

  • Promotes a continuous improvement culture and providing leadership in this area.

  • Establishes effective partnerships with other individuals, departments, cross- functional teams and JSC affiliates so that analytical services are well understood and coordinated.

  • Represents JSC where appropriate in meetings and other communications with regulatory authorities & industry meetings

We would love to hear from YOU, if you have the following essential requirements:

  • At least 5 years relevant experience within regulated biologics/ pharmaceutical industry

  • Minimum of 3 years in a Supervisory/ Leadership role in another Technical/Systems area also eligible

  • Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.

  • Demonstrated ability to lead a team to successfully deliver complex projects.

  • Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.

  • Focus on patients and customers at all times.

Desirable

  • Experience with working in a global/matrix organization preferred

This is what awaits YOU at J&J:

This is an opportunity to work with a ground-breaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.

We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.

Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:

  • An opportunity to be part of a global market leader.

  • A dynamic and inspiring working environment.

  • Opportunities to work on challenging projects and assignments.

  • Possibilities for further personal and professional development/education

  • Excellent benefits

Equal Opportunity:

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Ireland-Cork-Cork

Organization Janssen R&D Ireland (7566)

Job Function Quality Control

Req ID: 2406199424W

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