Senior Manager, Process Compliance Review and Analysis

Fortrea; Maharashtra; On-site; INR 1,800,000 - 3,500,000; Full time

Job summary

Fortrea is seeking a senior quality and regulatory professional to lead quality processes for pharmacovigilance and safety writing engagements in India. The role focuses on CAPA management, audit readiness, and driving process improvements across multiple projects.

The candidate should have extensive experience in pharmaceutical quality systems, regulatory compliance, and data-driven quality initiatives, with the ability to interact with clients and delivery teams to ensure timely inspections

Qualifications

• Bachelor/Master/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Responsibilities

• Institute and implement a Quality process across designated PV and safety writing engagements.
• Accountable for quality, CAPA and compliance deliverables for assigned PV and Safety writing engagements.
• Drive implementation of best practices and process improvement for the assigned projects.
• Drive CAPA management and audit readiness across projects.
• Identify quality trends and suggest corrective actions.
• Function as a Point of Contact for regulatory updates and quality assurance concepts on assigned projects.
• Act as the process and quality expert for the Client.
• Develop PQ SOPs and WIs and support regulatory inspections.

Skills

Quality management

CAPA

Regulatory updates

Process improvement

Data analysis

PV/Safety writing

Education

Bachelor/Master/PhD in Life Sciences or related field

Job description

Job Overview

It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Job Overview

It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.

Summary Of Responsibilities

• Responsible for instituting and implementing a Quality process across designated PV and safety writing engagements.
• Accountable for quality, CAPA and compliance related deliverables for the assigned PV and Safety writing engagements.
• Drive implementation of best practices and process improvement for the assigned projects.
• Responsible for driving quality culture for the assigned projects.
• Drive CAPA management and audit readiness across projects.
• Identify quality trends and suggest corrective actions.
• Implement a feedback process and track implementation of feedback.
• Function as a Point of Contact for the delivery team for regulatory updates, quality assurance concepts, applicable procedures, practices, and conventions on the assigned projects.
• Act as the process and quality expert for the Client.
• Initiate and support initiatives for standardization of quality processes and process excellence across projects within the practice.
• Perform Analysis of data and if required, suggest strategies for process improvement/excellence.

• Perform and Review of analysis of data performed and drive strategies for process improvement/excellence

Responsible for Driving Proactive Quality processes across the project.

• Oversee all aspects of quality reviews, metrics, analysis, outcomes, actions across the projects.
• Support internal audits of PV/ Safety writing projects as per the audit calendar and support as required for general systems and process audits.
• Oversee and conduct process reviews to ensure regulatory and client requirements and implement process improvements.
• Work with delivery head & SME to develop, implement Quality Management Plan, provide inputs to Quality Agreements, Training Plans, and monitor Quality SLAs for all designated projects.
• Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests.
• Ensure implementation of Quality Management Plan and/or the Quality Agreement for assigned projects.
• Support Computer System Validation related activities as required.
• Perform a critical role to ensure organization wide inspection readiness at all times.
• Develop general or client-specific PV SOPs and WIs.
• Assess client conventions and provide inputs on their relevance to regulatory requirements.
• Assist delivery teams to identify training needs based on quality review findings.
• Identify process improvements and support delivery teams in the implementation.
• Support practice head in developing process framework, new offerings, and customized solutions for clients.
• Assist practice head in ensuring that training material & training plans are reviewed and updated on an ongoing basis, and in conducting training sessions.
• Support business development at practice level by contributing to RFP responses, proposals, and client presentations.
• All other duties as needed or assigned.

Qualifications(Minimum Required)

• Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science,

Pharmaceutical science, Nursing, Life Sciences, or related area.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

• 15 +years of experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with experience in Quality, leading quality, and process improvements across several Safety projects.

• Knowledge of regulatory requirements viz. GPV