QA Team lead

at  Johnson Johnson

“Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

POSITION SUMMARY

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.

EDUCATION AND EXPERIENCE

Essential:

• 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.

Desirable:

• 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.

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.