Clinical Supply Chain Manager - Change Control and Deviations Job at Amgen (Hyderabad)

Senior Manager Clinical Supply Chain

The Senior Manager, Clinical Supply Chain is a senior leadership role accountabl...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree in supply chain management, Engineering, Life Sciences, or Business Administration
advanced degree preferred
12+ years of progressive experience in supply chain, planning, or operations roles within the pharmaceutical or biotechnology industry
Deep understanding of GMP and GCP interfaces, regulatory requirements, and the complexities of managing investigational products
Proven success leading large, cross-functional organizations within a global, matrixed environment
Strong digital and systems acumen, with experience implementing or operating platforms such as SAP, Anaplan, or equivalent
Demonstrated expertise in end-to-end clinical supply chain management, planning, vendor management, and business performance management
Exceptional analytical, strategic thinking, and communication skills, with a proven ability to influence senior leaders and drive enterprise outcomes

Job Responsibility

Lead the Development Supply Chain execution team, with end-to-end accountability for clinical material demand execution, packaging order conversion, and global distribution
Provide strong people leadership and operational governance while driving continuous improvement across inventory management, purchase order execution, NPI readiness, and compliant execution of temperature-controlled and specialty shipping requirements
Execute clinical trial readiness, including master data, artwork, and documentation management, ensuring GMP-compliant execution across all clinical programs
Provide leadership oversight for change controls, deviations, and CAPAs, driving standardization, training, and inspection readiness across the clinical supply chain organization
Lead material master data initiation, order management, and execution support for clinical manufacturing and packaging operations
Ensure continuous manufacturing and packaging support through process order management, 24/7 material availability, and optimization of inventory and order execution efficiency
Lead clinical logistics and cold chain operations, including logistics service provider vendor management, depot network planning, and compliant shipping lane design
Oversee clinical customer service and distribution quality activities, including proof-of-receipt monitoring, temperature data review, investigational product reconciliation, and resolution of distribution-related quality events and service complaints

Manager Clinical Supply Chain

In this vital role, you will serve as Manager Clinical Supply Chain leading a te...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 8+ years of supply chain, logistics, planning, or operations experience
OR Master’s Degree and 8+ years of relevant experience
Experience in regulated manufacturing or life sciences industry preferred
Experience managing people required
Strong experience in supply chain planning, procurement, and material management
Demonstrated success in people leadership, driving accountability, results, and growth of a team
Experience in regulated environments, preferably in pharmaceutical or biotechnology industries
Hands-on knowledge of SAP or similar ERP systems for material planning and management
Excellent communication skills, including fluency in English both in oral and written communication
Strong problem solving and analytical skills towards driving robust decision making

Job Responsibility

Lead and develop a team of 5 Senior Associates across Clinical Finish Drug Product planning and Non-Amgen Medicinal Product procurement
Define clear priorities, performance expectations, coaching, goals, and career development
Ensure effective staffing, resource management, and succession planning to maintain operational success
Foster a culture of accountability, compliance, and customer focus
Drive adoption of new technologies and AI to increase team productivity and enhance performance
Oversee production order conversion, stock transfer order initiation, and clinical planning cycle facilitation to ensure product supply plans are executed against appropriately, including infrequent rush execution during off-hours for global operations
Ensure success in study close out activities including material destruction
Oversee setup, procurement and inventory management for Non-Amgen Medicinal Products
Coordinate issue triage, corrective actions, and workload prioritization with global peers
Provide guidance on complex operational matters

Fulltime

Supply Chain Manager For Clinical Trial Medications

In this role you will project manage the design, plan, and set-up of the study s...

Location

Sweden , Mölndal

Salary:

Not provided

Randstad

Expiration Date

Until further notice

Requirements

Masters or equivalent
fast learner
self-driven
comfortable working in a high pace R&D environment
collaborative team player
flexible
strong communication, planning and problem-solving skills
strong influencing, negotiating and problem-solving skills across geographical and cultural boundaries
ability to adapt and operate in bespoke multiple systems

Job Responsibility

Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply
Ensure effective communication with project teams and key partners across a global network
Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies
Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction
Manage the Interactive Response Technology (IRT) system to execute demand and supply planning
Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls

What we offer

competitive salary
benefits
collective agreements
large network
many social activities

Fulltime

Business Development Manager Supply Chain AXP

We are seeking a highly motivated and experienced Supply Chain Manager for our B...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3+ years of Supply Chain, Business Analytics, or Operations related experience
Or Master’s degree and 8+ years of Supply Chain, Business Analytics, or Operations related experience
Or Bachelor’s degree and 10+ years of Supply Chain, Business Analytics, or Operations related experience
At least 2 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Own end-to-end AXP business performance reporting, dashboards, and KPI governance
Own data insights, metric analysis, corrective actions including metric driven performance improvements
Own AXP Monthly Planning cycle readout and Supply Plan processes
Own AXP Integrated Business Planning processes including S&OP and associated monthly supply reviews
Lead development and continuous refinement of supply dashboards and metric alignment efforts
Ensure visibility into key performance drivers including Commercial & Clinical lot volumes, CMO footprint growth, Cost to Serve, and deviation trends and supply risk indicators
Provide actionable insights to support Quarterly Business Reviews and forward 12Q strategy discussions
Partner with Finance and Global Planning to align performance metrics with financial and LRS cycles
Partner with AXP Business Performance Manager to ensure digital tools and applications are best fit for purpose and aligned with Amgen Digital and Technology roadmap
Ensure full adherence to SOPs and corporate/regulatory requirements across the AXP team

Fulltime

Manager Clinical Customer Service and Logistics Vendor Management

In this vital role, you will serve as the Manager Clinical Supply Chain leading ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 8+ years of supply chain, logistics, planning, or operations experience
Master’s Degree and 8+ years of relevant experience
Experience in regulated manufacturing or life sciences industry preferred
Experience managing people required
Experience in clinical supply chain or pharmaceutical operations
Demonstrated people leadership in regulated environments
Understanding of GxP and clinical regulatory requirements
Experience with ERP systems (preferably SAP)
Experience with leveraging process automation and AI-supported processes
Strong communication and stakeholder management skills

Job Responsibility

Lead and develop team of 7 Senior Associates across Clinical Customer Service, Logistics Vendor Management and Development Supply Chain Technologies
Define goals, manage performance, and support career development
Ensure appropriate staffing, cross-training, and succession planning
Foster a culture of accountability, compliance, and customer focus
Drive adoption of new technologies and AI to increase team productivity and enhance performance
Ensure efficient and compliant execution of assigned clinical supply chain processes with patient-centric mindset
Closely coordinate issue triage and workload prioritization with global peers
Monitor KPIs and overall team performance and drive corrective actions and learning when needed
Provide guidance on complex operational matters
Ensure adherence to GMP, GDP, and regulatory requirements

Contract Development & Manufacturing Senior Manager

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

138394.45 - 187239.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Manufacturing, Operations, Process Development, or External Supply experience OR Master’s degree and 4 years of Manufacturing, Operations, Process Development, or External Supply experience OR Bachelor’s degree and 6 years of Manufacturing, Operations, Process Development, or External Supply experience OR Associate’s degree and 10 years of Manufacturing, Operations, Process Development, or External Supply experience OR High school diploma / GED and 12 years of Manufacturing, Operations, Process Development, or External Supply experience

Job Responsibility

Lead external Synthetic DS programs for ADC and Small Molecule modalities across development, clinical, and commercial stages
Serve as the primary interface with CDMOs/CROs and internal cross-functional teams including Process Development, Quality, Supply Chain, Analytical, Regulatory, and Strategic Sourcing
Drive sourcing activities including supplier selection, onboarding, scope of work development, and proposal management
Oversee manufacturing operations, technical transfers, compliance, and issue resolution with external partners
Ensure project delivery against quality, compliance, supply, timeline, and cost objectives
Lead risk management, escalation resolution, and operational decision-making across programs
Build strong internal and external partnerships to support program success and operational excellence
Influence and lead matrix teams in a fast-paced, complex environment
Manage quality systems activities including deviations, investigations, change controls, and CAPAs
Manage budgets, purchase orders, and financial forecasting for external manufacturing activities

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Qa operations manager

We are looking for a QA Operations Manager to serve as a trusted Quality partner...

Location

Canada , Vancouver

Salary:

105000.00 - 120000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in a relevant scientific discipline
8+ years of GxP industry experience
at least 5 years in a quality management or leadership role within pharmaceuticals, biotechnology, or a comparable regulated environment
strong command of current pharmaceutical regulations and guidances including FDA, Health Canada, EU, and ICH
hands-on experience with biological Drug Substance and aseptic manufacturing processes, including associated testing requirements
comfortable navigating systems such as ERP (SAP), eQMS, and LIMS
communicate with clarity and confidence
self-starter who takes ownership, drives results, and thrives with autonomy in a fast-moving, mission-driven environment

Job Responsibility

Developing and implementing quality systems and oversight programs for Drug Substance (DS) GMP manufacturing, including product changeovers, batch record review, and shop floor surveillance
Partnering with CMC teams as the embedded QA representative, contributing quality expertise and guidance to ensure regulatory and quality requirements are seamlessly integrated across CMC projects
Completing review and approval of GMP documentation - such as batch records, SOPs, logbooks, risk assessments - ensuring full GMP and regulatory alignment and in support of clinical batch disposition
Maintaining inspection readiness of the facility and identifying and escalating risks to members of the site leadership team
Supporting inspections and audits of the clinical manufacturing facility
Participating in end-to-end quality event management, including deviations, investigations, CAPAs, and change controls, collaborating cross-functionally to drive root cause analysis and on-time record closure
Contributing to manufacturing risk assessments, from identification and evaluation through to mitigation, documentation, and reporting
Managing material qualification reviews to support procurement and GMP compliant use of raw materials and components
Acting as a key quality partner across Manufacturing, QC, Supply Chain, F&E, and project management teams, ensuring seamless quality oversight of DS programs
Staying ahead of evolving Quality and Regulatory requirements, proactively assessing their impact on AbCellera and driving timely mitigation strategies to maintain compliance

What we offer

Equity
annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
professional development opportunities
comprehensive health benefits
scientific and technical mentorship is a priority

Fulltime

Sourcing specialist

Alcura, a Cencora company, offers end-to-end clinical supply services and world-...

Location

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor's or master's degree in business administration, supply chain management, life sciences, or a related field
5 + years of experience in strategic sourcing or procurement roles, preferably within the pharmaceutical or healthcare industry- clinical supplies in a clinical trial environment
Strong analytical and problem-solving abilities
Effective communication and interpersonal skills
Strong understanding of clinical trials sourcing processes and regulations
Strong client building and 3rd party relationship management
Outstanding ability to provide customer service with the highest standards of quality and excellence
Fluent in English and Spanish- the hiring process will be conduct on this language.

Job Responsibility

Provide assistance during negotiations with suppliers/vendors to secure service level agreements (SLAs), and other relevant operational and quality terms while ensuring adherence to regulatory compliance specific to drug sourcing for clinical trials
Handling offers and orders with customers
Support the Sourcing Project Manager in coordinating end-to-end project management of drug sourcing initiatives for clinical trials
Requesting procurement-related documentation
Providing pricing and terms information
Assist in tracking project progress, monitoring timelines, and addressing any issues/risks that may impact deliverables
Review and maintain most up to date customer messaging at all times
Ensure all billing activities are forecast within the month
Collaborate with internal teams to gather necessary information for accurate client quotations, ensuring compliance with pricing guidelines and regulations
Analyze client requirements and project specifications to create customized proposals that meet their needs effectively

Fulltime

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Clinical Supply Chain Manager - Change Control and Deviations

Job Description

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