Senior Manager – Quality Assurance
Location: Mumbai, India
Category: Quality
Platform: ThePharmaDaily.com Global Job Portal
The Senior Manager – Quality Assurance will lead GMP compliance, quality governance and operational oversight for Loan License Manufacturing (LLM) sites and Third-Party Manufacturers (TPMs). This role ensures alignment with Abbott quality standards, regulatory expectations and cross-functional business needs across India.
Lead and guide the team on GMP compliance for LLM operations in line with Abbott policies and procedures.
Monitor and ensure compliance of Loan License Manufacturing sites and TPMs to cGMP and Abbott standards.
Conduct scheduled site visits to verify quality systems, processes and documentation.
Ensure Pharmacopoeial compliance for all Abbott products manufactured at LLM sites.
Review stability data and control samples for ongoing product quality assurance.
Oversee timely and effective closure of Abbott Audit CAPA actions at LLMs.
Manage compliant investigation of market complaints, including root cause analysis, CAPA implementation and effectiveness verification.
Collaborate with cross-functional teams for responses to NSQs and government agencies.
Review and assess change controls, deviations, OOS and product failures related to Abbott-manufactured products.
Ensure all Quality Technical Agreements (QTAs) are established and maintained for LL and TPM sites.
Review and approve technical documents for tech transfer projects at TPMs, including FLQR and analytical method transfer.
Oversee GSR notifications and ensure timely compliance at TPMs for all Abbott products.
Lead regulatory compliance initiatives impacting processes and products at partner sites.
Review and approve change controls and deviations for TPMs in Abbott’s systems.
Drive efficient communication and execution of quality projects across cross-functional teams supporting India operations.
Recruit, mentor, train and guide the TPM QA India team to build strong functional capabilities.
Manage stakeholders across S&OP, regulatory, labeling, commercial, MS&T and planning functions.
Ensure compliance to Deloitte and Abbott processes across all LL sites in collaboration with site management.
Build a high-performance team culture with a focus on continuous improvement and quality excellence.
Manage and maintain TPM and product-related quality databases.
Customize and periodically update quality SOPs and work instructions to meet regional requirements.
Oversee data integrity, confidentiality and regulatory documentation readiness.
Manage expectations with internal and external stakeholders regarding quality and regulatory requirements.
Support AVD projects and ensure all quality and regulatory needs are fulfilled for LL sites.
Provide expert guidance to cross-functional teams on GMP, regulatory compliance and product quality decisions.
Promote global standardization, simplification and compliance across TPM QA operations.
Direct Reports: 2
Indirect Reports: Approximately 50 contingent workers across LLM sites (SAP user management).
Key quality contact for all Loan License products.
Ensure compliance with Quality Technical Agreements, Abbott policies and regulatory requirements.
Oversee tech transfer and FLQR for new and existing products.
Lead metrics review, change control management and implementation of global EQD and quality policies.
Provide guidance to LLMs and TPMs on investigations related to market complaints, OOS and OOT.
Build networks to share best practices and stay aligned with global and regional regulatory changes.
Education
B.Pharm, M.Pharm or Master’s degree in Science.
Additional qualifications considered an advantage.
Experience
Minimum 12 to 15 years of experience in Quality Assurance, Quality Control, QMS, R&D QA, TPM Management, Tech Transfer, Dossier Review and Due Diligence.
Demonstrated experience in managing TPM operations in a regulated industry.
Strong background in GMP, regulatory compliance and quality system implementation.
Languages
Proficiency in English required.
Additional languages are beneficial.
Strong analytical, organizational and decision-making capabilities.
Ability to influence stakeholders and lead cross-functional teams.
Experience managing complex quality operations in fast-paced, changing environments.
Proven ability to handle confidential data with discretion and accuracy.
Skilled in managing multiple projects and shifting priorities efficiently.
Strategic thinker with a clear focus on results, compliance and operational excellence.
This comprehensive job post has been professionally rewritten for SEO, GEO targeting and GPT optimization, maximizing visibility and candidate engagement on ThePharmaDaily.com, the global career hub for pharmaceutical and life sciences professionals.
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