Sr Director, Compliance

Position Overview

• Location Type: Not Specified
• Employment Type: Full Time
• Work Schedule: Standard (Mon-Fri)
• Job Type: Not Specified
• Salary: Not Specified

The Sr. Director, Compliance will be a valued member of the Global Quality Leadership team, reporting to the Vice President, Global Quality, Regulatory and EHS. The incumbent will ensure that the overall cGMP compliance profile is maintained specifically through the development and implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory and client requirements. The role will engage effectively with regulators particularly in multiple branches at the FDA and identify mechanisms to assure that our practices and policies meet current regulatory expectations. They lead continuous improvement programs and support compliance activities both at a local and global level.

Requirements

• The job description does not list specific requirements.

Responsibilities

• Establishes and leads an inspection readiness program. Provides on-site support for inspection management for key inspections.
• Acts with intensity to advise collaboration with the Operations team, driving continuous improvement to effectivity and efficiency of quality systems processes, to deliver sustained compliance.
• Develops and maintains quality assurance and compliance policies and standard operating procedures, meeting domestic and global regulations and corporate policies.
• Leads and oversees efforts to respond to new or changing regulations, including but not limited to communicating regulations to leadership and affected areas, assembling and chairing work teams, and developing/providing education regarding regulatory requirements and developing a closed loop program for the effective implementation of major regulatory changes.
• Ensures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems.
• Delivers safe & effective products and makes Quality a competitive advantage by achieving an extraordinary GMP regulatory compliance with zero patient impacting events and drives quality strategy and culture.
• Attracts, develops and retains top talent to build an outstanding Compliance function. Implements the required interpersonal structures and operating mechanisms to maintain appropriate oversight of the compliance status of the business.

Additional Responsibilities

• The job description lists key responsibilities, but not a comprehensive list of additional responsibilities.