Sr. Director, Regulatory Affairs

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world's leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

JOB PROFILE:
Reporting directly to Chief VP Global Quality, the Senior Director of Global Regulatory Compliance and Affairs is responsible for developing, planning, and executing the regulatory compliance and regulatory affairs strategy in alig nment with key business strategies across the global healthcare organization.

RESPONSIBILITIES:

- Assist in developing and maintaining regulatory documentation - collect and coordinate information and support preparation of regulatory documentation for customer submission s (e.g., Drug Master Files), reports, labeling, registration, pre -certifications, and certifications ( e.g., FDA and ISO). Ensure that global sites are appropriately registered (e.g., FD A).
- Responsible for g lobal Internal Audit Program strategy, planning, development, execution, and maintenance.
- Execute corporate G xP compliance audits and assessments. Produce timely, detailed, and technically correct reports following these assessments. Provide guidance on solutions to resolve and prevent recurrence of identified issues.
- Conduct periodic research of global regulatory issues and disseminat e information to Quality, Operations, and Engineering departments and to senior management.
- Implement continuous improvement of regulatory compliance processes and procedures to ensure adherence to rapidly changing global regulatory requirements.
- Support global organization as a contributor to the Change Management p rocess between Jabil and its customers.
- Work closely with multiple stakeholders to ensure maintenance of S upply Chain compliance. Coordinate with Supplier Quality and Supply Chain on the development and maintenance of the Supplier Management program. - Coordinate with customers on results from customers' regulatory inspections and Notified Body audits and on activities related to field actions.
- Collaborate with s takeholders to ensure inspection readiness and proper coordination during the course of inspections.
- Ensure Regulatory Compliance function participates during regulatory inspections and audits. Provide on
- site inspection management during inspections and audits, as necessary ,
- Manage customer / regulatory authority inspection responses to include global evaluation, execution, and effectiveness checks. - Identify and track inspection near misses to make Qua lity System improvements as part of predictive compliance.
- Proactively e ngage with stakeholders to build a progressive and integrated Regulatory C ompliance and Affairs function.
- Provide GxP Compliance and Inspection Management training to maintain a high l evel of quality culture and awareness.
- Develop supporting metrics for business processe s that f acilitate trending of various information received from customers, including customer feedback on post market surveillance data.
- Understand the business, consider current trends in the medical device and pharmaceutical industry, and have the vision to develop processes that are efficient and adaptable.
- Create, deliver, and evaluate educational material to appropriate levels of management.
- Comply with and follow all procedures within the company security policy.
- Perform other duties and responsibilities as assigned.

KNOWLEDGE AND EXPERIENCE REQUIRED:

- Degree in Management, Science, Engineering, or other technical field required, and master's degree in Business Administration preferred
- Minimum of 10 years work -related experience in Quality Management with in a pharma/ medical devices or/and a highly regulated industry
- Operations management experience preferred
- Knowledge and experience with Six Sigma a s a disciplined, data -driven approach to continuous improvement
- Experienced Regulatory and Quality leader with proven history designing and implementing regulatory compliance policies and procedures and establishing a regulatory affairs strategy for Jabil and interfacing with customer regulatory professionals
- Proven experience leading C ustomer audits, health authority inspections, and R egistrar / Notified Body audits
- Ability to translate customer and business needs into regulatory and quality process es with in operations, engineering, and business services
- Experience in assisting worldwide manufacturing sites as part of inspection readiness planning
- Capable of providing vision and leadership regarding change management

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