QA Team Lead

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. 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 inclusive culture that values different perspectives and life experiences That is why we in J&J are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”. Role: QA Team Lead Location: Janssen, Ringaskiddy, Cork Position Summary: The role holder will lead compliance activities and QA operational activities related to Janssen Sciences Ireland (JSI) UC as per cGood Manufacturing Practice (cGMP). These activities include executive roles in leading change control, non-conformance investigations, compliance auditing, and other related quality system elements. General Scope of Responsibilities: Provides leadership and direction to the site management team in respect of specific quality system and or quality operation elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model. Provides leadership in the development and management of Quality through the following actions: Supports GMP qualification and validation activities through execution of supplier/contractor audits and directing review of qualification/validation documents to provide oversight of qualification and validation programs. To review and ensure their team interpersonal capabilities, personnel proficiencies and that the number of qualified personnel continuously matches expertise and workload needed. Supports the Site Quality Head and Quality Managers in mentoring the quality team to ensure professional and personal development of department personnel. Partners with other Departments to ensure that compliance programs are completed in an effective manner. Actively participates in management of the Quality Department through budget forecasting and preparation, training of staff, and deputizing for other members of the department management team as appropriate. Leads the QA team in the development and implementation of systems and procedures for the management of change control, as it applies to plant installations, systems, and operations in accordance with GMP. Leading the QA team in the development and implementation of systems and procedures for the GMP qualification of suppliers and contractors to JSI. Maintains records of qualification activities in accordance with GMP. Coordinates QA/QS staff in the development and implementation of systems and procedures for external audits and inspection management suppliers and contractors and reporting to plant management on the state of compliance at JSI. Assists the Site Quality Head and QA Managers in the management of quality inspections and audits of JSI by external parties/agencies. Leads for the tracking of commitments arising from audits and communication of information to site management. Deputises for the QA Manager where appropriate. Coordinates the activities of the group within quality to build a collaborative approach to goals and tasks. Through personal expertise, leadership and dedication, provides direction to the site in the development of a culture of quality and compliance. Domestic and international travel may be required Key Proficiencies Required: Excellent social skills. Ability to operate as part of a team is essential. Innovative. Excellent interpersonal skills both written and verbal. Attention to detail. Good problem-solving skills. Results and performance focused. Adaptable and flexible. Qualifications Qualifications and Experience: A minimum of 5 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Knowledge of Manufacturing Processes, GMPs and other industry applicable regulations including those of FDA, HPRA, EMEA and other authorities. Advanced degree (MS, MBA, PhD) preferred. Experience in direct interactions with regulatory agencies during site inspections. Key Individual Leader Proficiencies: Lead multi-functional team(s) in assigned area of responsibility as assigned by the Senior Leadership Team. Provide support for the site leadership team in the development of a culture of GMP compliance at JSI. Influence and facilitate the work of other departments and functions in achieving and maintaining a state of GMP compliance. Establish effective partnerships with other individuals, departments and JSI affiliates so that compliance activities are well understood and coordinated. Actively promote continuous compliance improvement programs. Represent JSI where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc. Demonstrate CREDO value of integrity. Actively promote and apply critical thinking to compliance activities. Develops and implements systems and metrics for ongoing measurement of quality and compliance at JSI. Significant Safety or Working Considerations: All employees are required to follow the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, Legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act (2005), all employees are required to: Take reasonable care to protect their own safety and that of their colleagues who may be affected by their actions. Always follow EHS rules and procedures. Understand the potential EHS impact of their activities. Attend and participate in EHS training. Use PPE and safety equipment as required. Report all incidents, accidents, and near miss events. Report unsafe plant, equipment, acts, procedures, or issues. Make suggestions to improve health and safety in the workplace. Actively participate in work area EHS teams. Equal Opportunity: Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location Ireland-Cork-Cork- Organization Janssen R&D Ireland (7566) Job Function Quality Requisition ID 2206035123W