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

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine, Biotherapeutics Manufacturing

The Biotherapeutics Manufacturing facility 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, an innovative 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 excellence 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 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 supports wellbeing and adopts innovation.

Job Summary:

The Quality Control Dept at J& J Innovative medicine BioCork is responsible for testing, review and approval of all commercial products, ensuring the product quality is achieved for raw materials, in process and final bulk materials, as well as providing environmental, utility and ongoing project support.

The primary responsibility of the QC Director is to ensure that all QC laboratories provide a compliant, timely and cost-effective quality control service.

Position Overview:

This position is responsible for leading and handling all Quality Control programmes and activities to support the site and manufacturing operations. These functions and activities include Quality Control testing, review and approval functions, Compliance activities, Product Release activities, etc. This role collaborates closely with various partners including Operations, MSAT, Quality Assurance, Product Quality Management (PQM), Value Chain Leaders (VCLs), Technical Launch Integrators (TLI), Site Leaders, and Finance.

Reporting Relationships:

The Director of Quality Control reports to the Site Head of Quality at the Biotherapeutics Manufacturing facility in Cork.

The responsibilities and the impact YOU will have:

• Responsible for appropriately staffing and developing the Quality Control organization to meet business needs and succession plans.

• Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J& J Standard of Leadership behavior model.

• Partners with other Site Quality Lab Leads to ensure harmonization and alignment with supply chain Quality Policies, Guidelines, Programs and Systems.

• Ensures financial leadership by developing appropriate operating and capital expense budgets and strives to ensure the Quality Control organization supply to Cost of Goods Sold (COGS) improvement.

• Ensure Safety and Quality standards are reliably maintained and align with J& J global guidelines and regulatory expectation.

• Anticipate and plan for future requirements in the QC, including such aspects as procedural requirements, Technical Problem-solving 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.

• Fosters a process-driven environment both within QC and with other Departments such that resources are employed efficiently and effectively.

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

• Establishes effective partnerships with other individuals, departments, cross- functional teams.

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

• 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.

• Ensure appropriately trained resources are deployed

• Gives strategic direction to the QC in the execution of their duties.

• Coordinates the activities of the groups within quality to create a collaborative approach to goals and tasks.

• Provides coaching, mentoring, and direction to Quality Control Department staff as appropriate.

• Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.

• Travels to locations to facilitate/coordinate activities, resolve issues, etc.

Essential:

• Advanced degree required in a scientific or engineering discipline.

• Approx. 7-10 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry.

• People management and leadership experience is required.

• Experience working with Quality systems is required.

• Extensive knowledge of chemical, biochemical and microbiological concepts is required.

• Knowledge of cGMP regulations and FDA/EU guidance is required.

• A strong scientific leader with a clear understanding of regulatory expectations.

• Ability to hire, develop and retain top talent for QC operations.

• Exposure to an international working environment in previous roles is preferred

• Regulatory and inspection experience is preferred.

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 crucial.

• Excellent interpersonal skills with a clear collaborative approach.

• Strategic thinking

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

• Consistent record in quality risk management and GMP requirements

• 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

• Quality leadership skills: problem solving, statistical thinking, design of experiments, etc.

• Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people’s energy, manages diverse team members.

• Innovative, tenacious, and passionate about quality.

• Time management skills.

• Attention to detail without losing sight of the big picture.

Desirable

• Experience with working in a global/matrix organization preferred