PHARMAFull-time
Sr Mgr Quality Assurance- On Site CMO Manager
By Admin · Quality Assurance & Quality Control
BANGALORE (IN)ONSITEPOSTED: 8/26/2026
PHARMAFull-time
HIRING ORGANIZATIONTEVA PHARMACEUTICALSBiopharmaceuticals / Life Sciences
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
The On-site CMO Manager – ExM Quality serves as Teva's Quality lead at assigned Contract Manufacturing Organization (CMO) sites and key suppliers. The role provides end-to-end quality oversight for external manufacturing operations and is responsible for compliant manufacturing, product release and reliable supply of Teva products across global markets. The position requires strong pharmaceutical Quality Management System (QMS), cGMP, CMO/supplier quality management, risk management and regulatory knowledge, together with cross-functional understanding of Supply Chain, Manufacturing Science & Technology (MS&T) and Regulatory Affairs.
Core Quality Responsibilities
Act as Teva's on-site quality representative and maintain a strong quality presence across CMO operations.
Provide quality oversight for manufacturing, product release and external supply activities.
Ensure CMO operations comply with cGMP requirements, regulatory expectations, Teva quality standards and Quality Technical Agreements.
Manage and oversee pharmaceutical QMS processes including deviations, CAPA, change control, investigations, APR/PQR, validation and SOPs.
Support robust investigation practices, root-cause identification and sustainable corrective actions.
Monitor quality actions and ensure timely closure of deviations, CAPAs and investigations.
Support batch documentation review, record closure and batch-release readiness.
Shop Floor & Manufacturing Oversight
Participate in daily production and operational review meetings as the quality representative.
Provide continuous quality oversight of manufacturing activities to support production plans and supply commitments.
Monitor production schedules, batch progression and operational performance.
Identify delays, bottlenecks, execution risks and emerging quality concerns.
Escalate critical and emerging issues to relevant Teva stakeholders in a timely manner.
Work closely with CMO site quality and operations teams to resolve issues and maintain supply continuity.
CMO & Supplier Quality Management
Provide direct quality oversight of assigned CMOs and key suppliers.
Act as the primary on-site liaison between CMO organizations and Teva's External Manufacturing Quality organization.
Maintain effective relationships with external manufacturing partners.
Monitor supplier/CMO quality performance and compliance.
Ensure external operations remain aligned with contractual Quality Technical Agreements and Teva quality expectations.
Support proactive identification and mitigation of supplier and manufacturing risks.
Supply Chain & Inventory Visibility
Maintain oversight of raw-material, packaging-component, work-in-progress and finished-goods availability.
Monitor end-to-end pharmaceutical supply processes including procurement, demand and capacity planning, inventory management, manufacturing planning, distribution and S&OP.
Monitor manufacturing schedules and supply assurance.
Support real-time batch visibility and risk management.
Support deviation, investigation and release-acceleration activities where required.
Identify potential supply constraints that could affect manufacturing, release schedules or customer commitments.
Collaborate with Supply Chain, Operations and Quality teams to protect uninterrupted product supply.
MS&T & Manufacturing Expertise
Demonstrate strong knowledge of manufacturing processes for solid oral dosage formulations.
Collaborate with MS&T teams on investigations, troubleshooting and manufacturing issues.
Apply understanding of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
Use quality-risk-management principles and data-driven decision-making to support manufacturing and quality outcomes.
Support product transfers, commercialization, process changes and product lifecycle-management activities.
Regulatory & Compliance
Maintain knowledge of global regulatory expectations covering markets such as USFDA, EMA, Health Canada and other international markets.
Understand pharmaceutical GMP requirements and ICH guidelines.
Maintain awareness of product registrations and post-approval changes across global markets.
Identify, assess and appropriately escalate regulatory and compliance issues.
Support regulatory inspections, customer audits and health-authority interactions.
Maintain inspection and audit readiness at CMO operations.
Risk Management & Quality Governance
Proactively identify, assess and escalate quality, compliance, operational and supply risks.
Work with relevant teams to establish mitigation and resolution plans.
Apply quality risk-management principles to external manufacturing operations.
Support governance of ExM quality systems and supply-chain quality activities.
Provide actionable reporting to External Manufacturing Quality leadership and relevant Teva functions.
Enable informed decision-making and rapid resolution of critical issues.
Operational Excellence & Continuous Improvement
Drive and support site-level quality, compliance and operational-excellence initiatives.
Partner with cross-functional teams to identify process-improvement opportunities.
Support process simplification and performance enhancement.
Promote sustainable corrective actions and improvements rather than short-term issue resolution.
Contribute to improved quality performance and reliable product supply.
Key Systems & Technical Tools
Quality Management Systems expertise.
TrackWise proficiency.
Veeva proficiency.
Regulatory-compliance and audit-management experience.
Strong understanding of pharmaceutical quality processes and external manufacturing governance.
Education & Experience
Bachelor's or Master's degree in Pharmacy, Chemistry or a related field.
10+ years of pharmaceutical Quality Assurance experience.
Significant exposure to CMO management.
Experience with Quality Management Systems and CMO oversight.
Proficiency in TrackWise, Veeva, regulatory compliance and audit management.
Strong cross-functional knowledge across Supply Chain, MS&T and Regulatory Affairs.
Leadership & Stakeholder Impact
Serve as the quality bridge between Teva and external manufacturing organizations.
Communicate quality, compliance, manufacturing and supply risks to senior stakeholders.
Provide leadership communication and actionable recommendations.
Influence CMO partners and internal cross-functional teams toward timely resolution of quality and supply issues.
Support global product supply while maintaining regulatory and quality standards.
Benefits & Total Rewards
Teva states that employees receive benefits designed to support wellbeing and professional development. The company highlights generous annual leave, reward plans, flexible working schedules where applicable, tailored health support and opportunities to contribute to the community. Teva's Twist career-development platform provides access to learning programs, short-term projects and internal-growth opportunities. The company also emphasizes an inclusive and equal-opportunity workplace.
REQUIRED VERIFIED SKILLS
Pharmaceutical Quality Assurance
Quality Management Systems
CMO Management
External Manufacturing Quality
cGMP
Deviations
CAPA
Change Control
Investigations
APR/PQR
Validation
SOPs
Supplier Quality Management
Quality Technical Agreements
USFDA
EMA
Health Canada
ICH Guidelines
Regulatory Compliance
Audit Management
Regulatory Inspections
Customer Audits
Health Authority Interactions
Product Transfers
Commercialization
Process Changes
Lifecycle Management
Quality Risk Management
NTM/GNTM
Complaint Handling
Escalation Management
Supply Chain Quality
Solid Oral Manufacturing
Critical Quality Attributes
Critical Process Parameters
TrackWise
Veeva
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Teva Pharmaceuticals is actively hiring for this position.
INDUSTRY: Biopharmaceuticals / Life Sciences
RECOMMENDED TRAINING
1/5
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