Johnson & Johnson Karrieren
Regulatory Compliance Director
Requisition ID: 1905729714W
Regulatory Compliance Director (f/m)
- Provides leadership for site development, deployment and maintenance of strategic regulatory and quality requirements within the JSC sites assigned to him.
- Leads the core activities of expert cGMP compliance support for key JSC pharmaceutical production activities regulated by FDA, EMEA, Japan, and other key international regulatory bodies, while continuing to work closely with JJRC, quality assurance directors, and managers within the region to assure compliance programs are implemented and maintained at the applicable level.
- Collaborates with the business partners to mitigate compliance risk and support the sites in preparing for routine and pre-approval health inspection, assists during the inspection and supports and reviews the response and follow up activities.
- Ensures proactive compliance oversight and vigilance to the assigned sites and businesses and provides compliance active in critical issues and problem resolution.
- Actively participates in site escalations and support the sites and their quality organizations for crisis management. Supports ESI Q for compliance vigilance at external sites and issue management teams.
- Works closely as liaison with key quality and compliance partners within the JSC global network, particularly in areas of interest regarding regulatory requirements and supports the strategic alignment to the Global Q&C policies and standards.
- Proactively identifies and prioritizes compliance risks at the assigned sites or across the supply chain in general and thereby partners with Compliance peers within the group and within Enterprise Regulatory Compliance, as appropriate, for consistency and leveraging opportunities. Makes decisions regarding the applicability of cGMP and other Health Authority regulations to sites and manage the escalation and resolution of Quality and Compliance issues.
- Ensures professional deployment of new upcoming requirements and new technologies.
- Participates in a proactive regulatory outreach group toward new and upcoming regulations. Provides Compliance support to strategic projects/initiatives in Q&C and in the Supply Chain and supports the deployment and the implementation of Quality Risk Management concepts to control risks and maintain vigilance.
- Supports the review, the assessment, the deployment and implementation of the Golobal and Enterprise Standards at the sites. Actively participates in the lifecycle management process as needed (e.g. new product launch, significant changes) and in the site product and management reviews.
- BA or BS in Biology, Chemistry, Pharmacy or related field is required.
Must possess a thorough technical knowledge of cGMPs and International regulatory requirements.
At least 10 years of experience performing GMP audits/support of pharmaceutical manufacturing sites is required.
A minimum of 10 years of experience in Quality Assurance, Regulatory Affairs and/or Compliance is required.
Must possess intimate knowledge of the pharmaceutical manufacturing, testing and reporting of regulatory requirements. Must possess the ability to effectively communicate requirements and regulatory issues.
- Hands-on experience interacting with regulatory authorities is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Cilag GmbH International (8525)