Johnson & Johnson Careers
Senior Director Quality
Requisition ID: 1805674927W
Role: Senior Director Quality
Location: Cork, Ireland
Reports to: VP of Global Quality
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, in particular 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.
The facility in Ringaskiddy is operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
In 2017, Janssen Sciences Ireland UC announced that it is to invest more than €300 million in the expansion of its manufacturing plant that will create more than 200 new jobs.
Janssen Pharmaceutical Sciences (Little Island) Company has been manufacturing bulk active pharmaceutical ingredients in Cork since 1981. Products are sold throughout the world to other Janssen and third party companies, where they are further processed into tablets, creams, or injectable dosage forms. These finished products are used in the treatment of a range of Psychiatric, Gastro Intestinal and Fungal disorders as well as in the treatment of HIV.
The Senior Director of Quality is responsible for leading all Quality related programs and activities to support both Janssen sites and manufacturing operations. These functions and activities include Quality Control testing, Quality Assurance review and approval functions, Compliance activities, Product Release activities, etc.
What you’re great at:
You will be responsible for appropriately staffing and developing the Quality organization to meet business needs and succession plans. You will also provide 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.
Vital to the success of this role you partner with other JSC Site Quality Heads and Headquarters Quality head to ensure harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems.
You will hold a leadership role on the Site Leadership Team, lead by the Site General Manager for site operations and also be responsible for ensuring financial leadership by developing appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement.
Additionally, the Quality Director supports Quality PE and Metrics Program and is joint owner of the Site Quality MAP.
As a Senior Quality Director, your typical day may include:
Provide leadership to direct reports and JSC through:
•Developing and champion an organizational culture that promotes behaviors that lead to superior business performance and organisational excellence.
•Create a commitment to customer service.
•Engage in proactive relationships with the local/regional/national regulatory authority
•Analyze regulatory authorities programs and activities in areas relevant to biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
•Encourage, supports and directs initiatives and programs that lead to improved quality and improved regulatory compliance.
•Lead and guides staff and those involved in quality activities to achieve the best results.
•Mentor and coaches staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel.
•Interface professionally with other departments, as well as staff from other affiliates and JSC in fulfilling his/her responsibilities.
•Function as a key member of JSC Worldwide Quality Leadership Team.
•Ensure all employees follow all applicable JSC and governmental (EPA, OSHA, FDA, etc.) regulations, policies and guidelines.
•Apply ISO 9001 as applicable:-
•Ensure that processes needed for the quality management system are established, implemented and maintained,
•Report to management on the performance of the quality management system and any need for improvement,
•Ensure the promotion of awareness of customer requirements throughout the organization.
To be part of this high performing team you will have great attention to detail, alongside:
•Advanced degree required in a scientific or engineering discipline
•Must be eligible for inclusion on the site manufacturing licence as Qualified Person
•10-15 years experience in a significant leadership position within the biological and/or pharmaceutical industry.
•5 years experience in a Quality leadership role required
•Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Proven success in managing in a global organization
•5 years experience in a supporting functional area (e.g. R&D, Manufacturing, Engineering, EHS, Technical Services)
What we’re about:
We are passionate about our work, and 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. We share a kind of DNA where we’re each:
•Excellent interpersonal skills
•Quality management 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 site of the big picture
•Keeps up to date with technical and managerial developments in the industry
•Results and performance driven
•Adaptable and flexible.
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen R&D Ireland (7566)