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QA Team lead
Office location: Cork, Ireland
This position is responsible for managing compliance activities and QA operational activities related to Janssen Sciences Ireland (JSI) UC/Janssen Pharmaceutical Sciences (JPS) UC as required by Good Manufacturing Practice (GMP). These activities include executive roles in managing change control, non-conformance investigations, compliance auditing, and other related quality system elements.
Responsibilities & Accountabilities
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 organizational capabilities, personnel competencies and that the number of qualified personnel continuously matches expertise and workload needed.
- Supports the Site Quality Head (JPS) and Quality managers in coaching and 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 efficient manner and are effectively maintained.
- 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.
- Coordinates QA/QS staff 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.
- Coordinates QA/QS staff in the development and implementation of systems and procedures for the management of non-conformance investigations as they apply to validation, plant operations and materials. Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
- Tracks commitments arising from investigations.
- Coordinates QA/QS staff in the development and implementation of systems and procedures for the GMP qualification of suppliers and contractors to JSI/JPS.
- 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/JPS.
- Assists Site Quality Head, QS Manager and QA Manager in the management of quality inspections and audits of JSI/JPS by external parties/agencies.
- Manages the tracking of commitments arising from audits and communication of information to site management on commitment completion.
- Deputizes for the QA manager, QS manager and for the Site Quality Head in JPS as appropriate.
- Gives direction to the QA/QS Group in the execution of their duties.
- Coordinates the activities of the group within quality to create a synergistic approach to goals and tasks.
- Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.
- Domestic and international travel may be required.
Key competencies required:
- Excellent interpersonal skills.
- Ability to operate as part of a team is critical.
- Customer focus.
- Excellent communication skills both written and verbal.
- Attention to detail.
- Good problem-solving skills.
- Results and performance driven.
- Adaptable and flexible.
Education and Experience
- Bachelor’s degree in a scientific/technical discipline required.
- 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.
- Demonstrated knowledge and application of industry 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.
- Experience in auditing of external suppliers, contractors and vendors.
Key individual leader competencies
- Lead a cross functional team(s) in assigned area of responsibility as assigned by Senior Leadership Team.
- Provide support for the site leadership team in the development of a culture of GMP compliance at JSI/JPS.
- 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/JPS affiliates so that compliance activities are well understood and coordinated.
- Actively promote improvement programs towards continuous compliance improvement.
- Represent JSI/JPS where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
- Demonstrate credo value of integrity.
- Actively promote and apply strategic thinking to compliance activities.
- Develops and implements systems and metrics for ongoing measurement of quality and compliance at JSI/JPS.
Significant Safety or Working Considerations
All employees are required to comply with the requirements of the company’s
Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures,
local legislation and duties outlined in the site EHS Manual.
In line with the Safety Health & Welfare at Work Act (2005), all employees are required
- Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
- Comply with EHS rules and procedures at all times.
- Understand the potential EHS impact of their activities.
- Attend and participate in EHS training as required.
- 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.
- Not turn a ‘blind eye’ to unsafe acts or situations.
This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.
Working at Johnson & Johnson
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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
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