Senior Manager, Process Compliance Review and Analysis – Fortrea
Location
Pune, India
Job Type
Full-time
Experience Required
10+ years of experience in the Pharmaceutical, Biotechnology, or CRO industry, with strong expertise in Pharmacovigilance (PV), Safety Writing, Quality Management, Compliance, CAPA, and Process Improvement.
Experience leading quality initiatives across multiple global safety projects is required.
Estimated Salary Package (Market Standard)
₹28 – ₹40 LPA (approx.), depending on experience, domain expertise, and interview performance.
Job Overview
The Senior Manager, Process Compliance Review and Analysis is responsible for driving quality, compliance, and process excellence across Pharmacovigilance (PV) and Safety Writing projects. The role focuses on implementing quality management systems, ensuring regulatory compliance, leading CAPA initiatives, supporting audits and inspections, and promoting continuous process improvement across client engagements.
Key Responsibilities
Implement and manage quality processes across PV and Safety Writing projects.
Ensure quality, compliance, and CAPA deliverables are completed on time.
Drive quality culture and continuous process improvement initiatives.
Lead CAPA management, audit readiness, and regulatory inspection support.
Monitor quality metrics, identify trends, and recommend corrective and preventive actions.
Establish and manage feedback mechanisms across projects.
Serve as the quality and regulatory process expert for internal teams and clients.
Support the standardization of quality processes and operational excellence.
Analyze quality data and recommend strategies for process improvement.
Conduct and oversee process reviews to ensure regulatory and client compliance.
Support internal audits, system audits, and Computer System Validation (CSV) activities.
Develop and maintain Quality Management Plans, Quality Agreements, SOPs, and Work Instructions (WIs).
Assist delivery teams in identifying training needs and implementing quality improvements.
Contribute to business development by supporting RFPs, proposals, and client presentations.
Support practice leadership in developing process frameworks, training programs, and new service offerings.
Ensure organization-wide inspection readiness at all times.
Educational Qualification
Bachelor's, Master's, or PhD in:
Medicine
Alternative Medicine
Medical Sciences
Pharmaceutical Sciences
Nursing
Life Sciences
Or a related healthcare discipline
Equivalent relevant experience may be considered.
Required Skills
Strong expertise in Pharmacovigilance (PV) and Safety Writing.
In-depth knowledge of Good Pharmacovigilance Practices (GVP), FDA, and EU regulatory guidelines.
Experience in quality management, compliance reviews, and CAPA implementation.
Strong understanding of single case processing and safety assessments.
Knowledge of Lean and Six Sigma methodologies.
Experience with audit management and regulatory inspections.
Understanding of Computer System Validation (CSV).
Proficiency in Microsoft Office Suite.
Excellent analytical, leadership, communication, and stakeholder management skills.
Strong problem-solving and process improvement capabilities.
Preferred Qualifications
Experience reviewing the quality of safety reports from medical, scientific, and documentation perspectives.
Experience in quality trend analysis, gap identification, and training needs assessment.
Proven experience driving quality improvements across global Pharmacovigilance projects.
Work Environment
Office-based role with collaboration across global teams.
Requires interaction with internal stakeholders, clients, auditors, and regulatory authorities.
May involve participation in global meetings and regulatory inspection activities.
Who Should Apply
Experienced Pharmacovigilance and Safety Writing professionals seeking leadership roles in Quality Management and Compliance.
Candidates with expertise in regulatory compliance, audit readiness, CAPA management, and process excellence within pharmaceutical, biotechnology, or CRO organizations.
Professionals looking to lead global quality initiatives and support regulatory inspections in a client-facing environment.
Uttar Pradesh :
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