Senior Manager Quality Control

at  Johnson Johnson

Role: Senior Manager Quality Control
Location: Johnson and Johnson Innovative Medicine, JSI Ringaskiddy, Cork
Reports to: Director of Quality Control, JSI
Closing Date: 3rd October
Johnson & Johnson Innovative Medicine Ringaskiddy are recruiting for a Facilities Manager.
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 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/.
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.
At Johnson & Johnson, we all belong.

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 give 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 sophisticated 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 accepts 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 a diverse group of candidates for our open roles.

Job Summary:
The Senior Manager for the Quality Control Team at J&J innovative medicine is responsible for the execution of all activities under the remit of a Quality Control Operations Lab organisation, with the primary responsibility to ensure that the QC Lab delivers a compliant, timely and cost-effective service to the Business.
Quality Control at J&J innovative medicine responsibilities include high quality, faced paced, complaint delivery of testing and release commitments, review and approval of results and ensuring the quality of raw materials, in process and final bulk materials, as well as providing environmental, utility, and ongoing project support and delivery of capital investments commitment and continued optimization and evolution of the QC organisation.
The QC Laboratory Manager role leads the relevant laboratories to deliver these services along with other agreed functional goals, while maintaining an environment of continuous improvement, customer focus and awareness of business deliverables.
This is a diverse Lab Group which provides key services to the wider QC Operations labs, the Large Molecule Quality Network as well as J&J Operations and TDS-AD.
The Senior Manager in Quality Control 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 QC testing 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.
• A Focus on Lean Operational excellence approach to Laboratory operations.
• 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

The responsibilities and the impact YOU will have:

• Seeing opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc.
• Runs the relevant QC Laboratories to provide compliant, timely and cost-effective QC support to the JSI.
• Approval of all required GMP documentation related to QC Lab Operations.
• 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.
• Defines Quality Control Policies, in consultation with QA and corporate guidance and alignment with the Large Molecule Quality Organisation
• Anticipates and plans for future requirements and agility in the Labs, including such aspects as procedural requirements, capital planning, personnel recruitment planning, compliance requirements, efficiency and optimization objectives and anticipated changes needed to reflect future demand.
• Ensures systems are in place to assure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards and guidelines.
• Planning and delivery the QC digital and Technology Objectives in alignment with the J&J innovative Medicine Cork Lab Strategic Objectives,
• 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.
• Promotes a continuous improvement culture and providing leadership in this area as well as Seeing opportunities to improve the services provided e.g., new technologies, improved vendor processes, cost, quality etc.
• 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.
• Represents QC as a business Unit supporting all the Business Units

QUALIFICATIONS

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

• BSc in a scientific/technical subject area required.
• At least 8 years proven experience within regulated biologics/ pharmaceutical industry
• Minimum of 5 years in a Supervisory/ Leadership role in another Technical/Systems area also eligible
• Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Proven ability to lead a team to successfully deliver sophisticated projects.
• Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.
• Always focus on patients and customers.

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 subject areas, 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 ambitious projects and assignments.
• Possibilities for further personal and professional development/education
• Excellent benefits

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

• Seeing opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc.
• Runs the relevant QC Laboratories to provide compliant, timely and cost-effective QC support to the JSI.
• Approval of all required GMP documentation related to QC Lab Operations.
• 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.
• Defines Quality Control Policies, in consultation with QA and corporate guidance and alignment with the Large Molecule Quality Organisation
• Anticipates and plans for future requirements and agility in the Labs, including such aspects as procedural requirements, capital planning, personnel recruitment planning, compliance requirements, efficiency and optimization objectives and anticipated changes needed to reflect future demand.
• Ensures systems are in place to assure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards and guidelines.
• Planning and delivery the QC digital and Technology Objectives in alignment with the J&J innovative Medicine Cork Lab Strategic Objectives,
• 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.
• Promotes a continuous improvement culture and providing leadership in this area as well as Seeing opportunities to improve the services provided e.g., new technologies, improved vendor processes, cost, quality etc.
• 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.
• Represents QC as a business Unit supporting all the Business Unit