Manager QA, External Audit

FTINDDDBLR Fortrea Development India Private Limited_BLR; Bengaluru; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Fortrea in Bengaluru, India seeks an experienced Senior Regulatory Compliance Lead to manage and ensure proper execution of audit, inspection programs, and quality systems. The role focuses on leading end-to-end regulatory activities, interpreting standards, and driving continuous improvement in RC and QA processes.

The ideal candidate has 10+ years in regulatory environments, strong data interpretation skills, and proven ability to communicate and negotiate with internal stakeholders and

Qualifications

• Bachelor's degree in Life Sciences or equivalent Life Science experience; Fortrea may consider relevant experience in lieu of education.
• Experience in regulatory environments (GXP) and industry quality systems/standards.
• Ability to interpret regulations and lead process improvements.

Responsibilities

• Oversees and leads execution of client audits, for-cause audits and regulatory inspections end to end.
• Ensure consistent implementation, use and review of SOPs.
• Escalate issues to management and implement solutions including preventative actions.
• Negotiate with internal stakeholders to improve quality and increase efficiencies.
• Analyze data to drive process improvements in RC and QA.
• Lead interactions with clients or regulatory agencies.
• Interpret quality regulations/standards and create policies and procedures.
• Ensure RC and QA responsibilities are followed as per controlled documents.
• Conduct internal audits such as process/system and service provider quality assessments.
• All other duties as needed.

Skills

Leadership

Regulatory compliance

Quality systems

Data analysis

Negotiation

Communication

Education

Bachelor's degree in Life Sciences

Job description

Job Overview

Manages and ensures proper execution of the audit and inspection programs.

Summary of Responsibilities

• Oversees and leads execution of client audit, for-cause audit and regulatory inspection end to end activities.
• Ensure the consistent implementation, use and review of SOPs.
• Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions.
• Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies.
• Analyze and interpret data to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes.
• Lead and effectively manage constructive crucial interactions with clients or regulatory agencies.
• Interpret applicable quality regulations/standards and create appropriate policies and procedures.
• Ensure Regulatory Compliance and Quality Assurance (RC and QA) management responsibilities, as indicated in applicable controlled documents, are followed.
• Conduct internal audits as directed, such as process/system and service provider quality assessment for qualification/requalification.
• All other duties as needed or assigned.

Qualifications (Minimum Required)

• A minimum of a bachelor's degree in Life Sciences preferred (or equivalent Life Science experience). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience may be substituted for education.

Experience (Minimum Required)

• 10+ years of experience in regulatory environment (experience in 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.

EEO & Accommodations

Learn more about our EEO & Accommodations request here.

Company Culture

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.