Regulatory Compliance and Quality Assurance Lead

We are seeking an experienced Regulatory Compliance and Quality Assurance Lead to oversee and manage the execution of audit and inspection programs.

Job Overview The successful candidate will be responsible for managing and ensuring proper execution of audit and inspection programs, leading functional process improvement initiatives, and interpreting applicable quality regulations and standards.

Responsibilities

• Oversees and leads execution of client audit, for-cause audit, and regulatory inspection end-to-end activities
• Ensures consistent implementation, use, and review of Standard Operating Procedures (SOPs)
• Escalates issues to management in a timely manner and implements appropriate solutions, including preventative actions
• Negotiates with functional and operational internal stakeholders to improve quality and increase efficiencies
• Analyses and interprets data to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes
• Leads and effectively manages constructive crucial interactions with clients or regulatory agencies
• Interprets applicable quality regulations/standards and creates appropriate policies and procedures
• Ensures Regulatory Compliance and Quality Assurance (RC and QA) management responsibilities are followed
• Conducts internal audits as directed

Requirements

• Minimum of a bachelor's degree in Life Sciences (or equivalent Life Science experience)
• 10+ years of experience in a regulatory environment (GXP roles)
• Experience and regulatory expertise of industry quality systems/standards
• Ability to interpret applicable regulations/standards
• Experience in leading process improvement initiatives
• Ability to communicate and negotiate with internal stakeholders effectively

Physical Demands/Work Environment

• Some overtime and weekend work may be required
• Travel required