Summary
Manages a team of individual contributors and/or supervisors, and is accountable for conducting effective performance management. Directs operations related to the development and continued growth of the organization's Quality Control processes, from establishing quality standards through devising testing methods, quality assurance plans, and inspection procedures. Ensures that production processes and finished products comply with established company and regulatory standards. Provides coaching and guidance to team in the identification of risks and development of mitigation plans, monitoring of data, and development of meaningful KPIs.
Description
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
Job Function:
QualityJob Sub Function:
Quality ControlJob Category:
People LeaderAll Job Posting Locations:
Ringaskiddy, Cork, IrelandJob Description:
Role: QC Manager NPI and Product LCM
Location: Johnson and Johnson Innovative Medicine, JSI Ringaskiddy, Cork
Reports to: Director of Quality Control
Live Our Credo & Pursue Our Purpose:
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.Johnson and Johnson Innovative Medicine, 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 powerful 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.
What is it like to work at Johnson and Johnson Innovative Medicine, Ringaskiddy, Cork
Culturally, we are putting the needs of Our Credo customers 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 perfection for clinical trial and Commercial drug substance Manufacture and Release.
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 adopts innovation. This is empowered through our Talent Council in which both managers and individual contributors drive employee development and university engagement.
The QC Manager NPI and Product LCM is responsible leading a multi functionary team with responsibility for the execution of all activities under the remit of the New Product introduction at J&J Innovative medicine and subsequent Product Lifecycle Management activities of commercial products.
The NPI Manager 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.
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 conclusive.
Excellent interpersonal skills with a clear collaborative approach.
Critical thinking
Ability to operate as part of a team and influence a team is crucial.
Consistent 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:
Finding opportunities to improve the process for delivering NPI, supporting ongoing lifecycle management, managing specification, data requests, filing submissions and technical coordination of regulatory requests.
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 QC, including such aspects as procedural requirements, CMO testing activities, personnel recruitment planning, financial coordination, 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 IMSC affiliates so that analytical request are well understood and coordinated.
Represents IMSC where appropriate in meetings and other communications with regulatory authorities & industry meetings
Approval of all required GMP documentation related to QC Lab Activities
Ensures Continuous Operational support for QC laboratory
Handles the relevant aspects of the J&J innovative Medicine Cork QC department compliance requirements, budget, HR and Talent objectives, Opex and Capital expenditure and Business Performance goals as well define and support delivery of the strategic direction of the Function.
We would love to hear from YOU, if you have the following crucial requirements:
At least 5 years proven 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 manage a team to optimally deliver sophisticated 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
