Snr Quality Assurance Manager

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 expansive culture that values different perspectives and life experiences That is why we in Ireland are working to create a broad 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”. Job Description: Snr QA Manager, Janssen Sciences Ireland, Ringaskiddy, Cork The position is responsible for the activities of the Quality Assurance Department in Janssen Sciences Ireland. This includes all quality operational activities including material release. In addition, the person will be responsible for the management of several quality systems including investigations, corrective actions and change control. They will set quality standards in respect of manufacturing and engineering systems and supervise compliance with those standards Key Responsibilities: Responsible for appropriately staffing and developing the Quality Assurance 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. Active member of the BU Leadership Teams. Provide leadership to quality team and the site through: Develops and champions an interpersonal culture that promotes behaviors that lead to outstanding business performance and interpersonal excellence. Encourages, supports and advises initiatives and programs that lead to improved quality and improved regulatory compliance. Leads and guides staff and those involved in quality activities to achieve the best results Mentors and coaches staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel. Interfaces professionally with other JSCI departments, as well as staff from other affiliates and JSC in fulfilling his/her responsibilities. Ensures all employees align with all applicable JSC and governmental (HPRA, FDA, etc.) regulations, policies, and guidelines.
INDHP Qualifications Qualifications Education: Advanced degree required in a scientific or engineering field Experience and Skills: Required: 5-10 years plus experience in a leadership position within the biological and/or pharmaceutical industry. Experience in a Quality leadership role 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. Shown success in leading in a global organization Desirable: 5 years’ experience in a supporting functional area (e.g.R&D, Manufacturing, Engineering, EHS, Technical Services) Eligible for inclusion on the site manufacturing license as Qualified Person Other: Gives operational direction to the QA group 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 Assurance staff as appropriate. Through personal expertise, leadership, and commitment, provides direction to the site in the development of a culture of quality and compliance. 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. 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. Primary Location Ireland-Cork-Cork- Organization Janssen R&D Ireland (7566) Job Function Quality Requisition ID 2105987131W