Senior Director Qa/Ra

The Senior Director QA/RA is a pivotal role responsible for overseeing and managing the Assurance and Regulatory Affairs functions within a dynamic life sciences organization. The primary focus is to ensure products meet all applicable regulatory requirements and industry standards while upholding high-quality standards.

This role requires a strategic thinker with deep regulatory insight, excellent leadership skills, and the ability to drive compliance and quality throughout all aspects of the organization. The Senior Director QA/RA will play a key role in shaping the company's regulatory and quality landscape.

Key Responsibilities:

• Develop and implement strategies for global regulatory compliance, including internal and industry metrics.
• Establish and maintain a robust quality management system.
• Oversee the development and implementation of quality policies, procedures, and processes.
• Implement continuous improvement initiatives for quality and regulatory processes.
• Develop and implement risk management strategies.
• Lead a high-performing QA/RA team across Fortis sites.
• Provide guidance, mentorship, and support to team members.
• Conduct internal and external audits to ensure compliance with quality standards, including FDA and third-party inspections.
• Partner with Director QA/RA Corporate Programs to ensure alignment of QA/RA process execution and process improvement opportunities.
• Collaborate with cross-functional teams for regulatory filings.
• Review and negotiate site level quality agreements.
• Coordinate QA/RA programs, including GMP third-party manufacturing facilities.
• Collaborate with R&D, Manufacturing, and other departments to align with quality and regulatory requirements to ensure safety requirements and QA/RA standards in product development and manufacturing are met.

• Serve as the Quality System Management Representative for applicable Fortis sites:

• Manage site quality leader reviews of marketing collateral from a quality perspective.
• Work closely with senior leadership to provide regulatory and quality insights and ensure alignment of QA/RA strategy with company objectives.
• Interact with regulatory agencies to facilitate approvals and submissions.
• Harmonize management review process across the divisions.
• Stay informed about regulatory changes and developments in the life sciences industry.
• Monitor industry trends and best practices for driving improvements.

Qualifications:

• Bachelor's or advanced degree in a relevant scientific discipline.
• Extensive experience in QA/RA roles within the life sciences industry.
• Strong knowledge of global regulatory requirements and quality standards.
• Leadership experience in managing cross-functional teams.
• Excellent communication and interpersonal skills.