Quality Audit & Compliance Advisor - Controlled Substances

BioSpace; Indianapolis (IN); On-site; USD 115,500 - 184,800; Full time

Benefits offered by this job

Comprehensive benefit program

Company-sponsored 401(k)

Vacation benefits

Flexible spending accounts

Employee assistance program

Job summary

A global healthcare leader is seeking an Advisor for Quality Audit and Compliance, focusing on Controlled Substances. The role requires significant experience in the pharmaceutical industry, strong regulatory knowledge, and proven skills in quality assurance and auditing. Responsibilities include ensuring compliance, leading audits, and providing guidance throughout the product lifecycle. The ideal candidate will have a bachelor's degree in Science or Engineering and be prepared for some domestic and international travel. This full-time position offers a competitive salary and comprehensive benefits.

Qualifications

• Minimum of five years' experience in the pharmaceutical industry.
• Strong knowledge of global regulations and guidelines.
• Prior auditing experience and certification preferred.

Responsibilities

• Ensure compliance with quality standards and regulations.
• Lead audits and inspections to assess compliance.
• Develop corrective and preventive actions for compliance gaps.

Skills

Regulatory interpretation

Quality assurance

Auditing

Project management

Interpersonal skills

Education

Bachelor's degree in Science or Engineering

Tools

Microsoft Office 365

Job description

A global healthcare leader is seeking an Advisor for Quality Audit and Compliance, focusing on Controlled Substances. The role requires significant experience in the pharmaceutical industry, strong regulatory knowledge, and proven skills in quality assurance and auditing. Responsibilities include ensuring compliance, leading audits, and providing guidance throughout the product lifecycle. The ideal candidate will have a bachelor's degree in Science or Engineering and be prepared for some domestic and international travel. This full-time position offers a competitive salary and comprehensive benefits.