Manager QA, External Audit

Fortrea Development India; Bengaluru; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Fortrea Development India is seeking a senior professional to lead execution of audit and inspection programs, ensuring regulatory compliance and QA integrity across the business. The role involves directing client audits, for-cause audits, and regulatory inspections end-to-end, while ensuring SOPs are consistently applied.

You will guide cross-functional teams, interpret regulations, drive process improvements, and escalate issues with timely preventive actions.

Qualifications

• Bachelor's degree in Life Sciences or equivalent Life Science experience.
• Fortrea may consider relevant and equivalent experience in lieu of education.
• Experience may be substituted for education.

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.
• Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes.
• 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.

Skills

Regulatory compliance

Quality Assurance

GxP

Process improvement

Stakeholder negotiation

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.
• Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes.
• 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.

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