QUALITY ASSURANCE MANAGER (REGULATORY AFFAIRS)

Johnson & Johnson is a globally renowned healthcare company committed to improving the health and well-being of people around the world.
With a rich history spanning over a century, we pride ourselves on delivering exceptional products and services that positively impact lives.
As an industry leader, we are dedicated to maintaining a world-class standard in everything we do.
Johnson & Johnson Innovative Medicine is located in Cork, Ireland, and we are currently seeking a Quality Assurance Manager to join our team.
Quality Assurance Manager We are seeking a highly skilled and motivated Quality Assurance Manager to manage and lead the activities for site Regulatory Affairs in our team at Ringaskiddy, Cork.
This is a unique opportunity to work with one of the most reputable companies in the healthcare industry and play a crucial role in ensuring the flawless quality of our products.
Responsibilities.
The activities include support for worldwide submissions of new drug clinical and commercial applications and post approval changes, change control support, manufacturing license maintenance, Japan and Taiwan site accreditation maintenance, consistency checks and Notarisation/Legalisation requests.
Interact with global partners such CMC-Global Regulatory Affairs, Regulatory Agency personnel and Local Operating Companies to resolve regulatory matters.
Consult with site management and CMC-Global Regulatory Affairs to establish strategies and oversee preparation of appropriate regulatory filings for site regulatory activities.
Provide leadership to quality team and the site.
§ Develop and champion an interpersonal culture that promote behaviours that lead to outstanding business performance and interpersonal excellence.
§ Responsible for appropriately staffing and developing the Regulatory Affairs Team to meet business needs and succession plans.
§ Partner with CMC-Global Regulatory Affairs and Local Operating Companies to develop, align and prioritize Regulatory Strategies to achieve businessobjectives of JSI.
§ Provide leadership and direction to the Regulatory Affairs and Site Management Teams to oversee the execution of compliant Regulatory Strategies that are aligned with business objectives of JSI.
§ Active member of the Local Change Control Board providing regulatory advice on proposed changes.
§ Provide Regulatory Support to site Qualified Persons.
§ Oversee the preparation of submissions in support of the site Manufacturing License and Site Accreditation maintenance.
§ Mentor and coach staff, as well as develop and implement training programs to ensure professional and personal development of department personnel.
Qualifications Requirements.
§ 5-10 years’ experience in a quality, technical, analytical, validation or compliance leadership role within the biological and/or pharmaceutical industry.
§ Advanced degree required in a scientific or engineering field.
§ Strong knowledge of regulatory requirements and quality standards.
§ Exceptional attention to detail and a commitment to producing flawless results.
§ Track record of successfully implementing quality improvement initiatives.
§ Excellent communication and leadership skills.
§ Ability to work collaboratively as a strategic partner with all other departments within the company.
§ Experience in a Quality leadership role required.
Desirable.
§ Experience on a site Manufacturing License as a Qualified Person.
§ Experience working in a Regulatory Affairs role.
§ Post graduate qualification in Regulatory Affairs or other.
At Johnson & Johnson, we believe in fostering an inclusive and diverse workplace.
We are an equal opportunity employer and value the unique contributions of all our employees.
If you require any reasonable accommodations or adjustments throughout the application process, please let us know.
We are committed to providing a fair and accessible recruitment process for all candidates.