# Regulatory Compliance and Quality Assurance Lead

**Company**: Fortrea
**Location**: Bangalore
**Experience**: senior
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bangalore/Manager-QA--External-Audit_266540?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/regulatory-compliance-and-quality-assurance-lead-f769fd21-fc2/

## Description

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

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## Skills

### Required
- regulatory compliance
- quality assurance
- GXP
- process improvement
- data analysis
- communication
- negotiation

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bangalore/Manager-QA--External-Audit_266540?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
