R&D Clinical - Quality Compliance Senior Manager Job at Amgen (Hyderabad)

R&D Manager (Clinical Nutrition) – On-Market Solutions Lifecycle Management

Forming part of a group of technical experts (SMEs) responsible for the continui...

Location

Malta , Marsa

Salary:

44800.00 EUR / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (Chemistry/Biology/Pharmaceutics/Chemical Engineering) with 10+ years experience
Masters degree with 5+ years experience or PhD with 1+ year experience
Relevant experience is preferably in the pharmaceutical industry with a broad background in solutions/drug development/lifecycle management
Familiarity with the utilization of analytical instrumentation in test methods and/or process engineering is desirable
Good knowledge of: Product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service
Design Control documentation and process
Statistical Analysis and/or Lean/Six Sigma tools
International/regional/national regulations and standards
Self-motivated, resourceful, and flexible
A self-starter is imperative

Job Responsibility

Lead a team of scientists responsible for the management and execution of lifecycle design supporting activities for the Clinical Nutrition Solutions On-Market products
Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc
Ensure that personal and team objectives align with key Segment initiatives
Manage routine and complex supplier notice of changes (SNCs), change control records, product code obsolescence and product end of life (EOL) activities in addition to general technical administrative tasks
Organize, plan and execute product changes in compliance with international regulations and quality standards
coordinate and set up cross-functional team meetings to ensure change execution, problem-solving and decision making
Independently plan, execute, and manage project(s) that span multiple disciplines with team, cross functions and regions
Employ project management tools to manage project schedules and budgets against milestones
review and apply best-demonstrated practices, team processes, and improve operational efficiency
Identify and resolve issues that may jeopardize project schedules and/or improve project timelines

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Competitive benefits
Discretionary bonuses
Long-term incentive

Fulltime

R&D Manager (Clinical Nutrition) – On-Market Solutions Lifecycle Management

Forming part of a group of technical experts (SMEs) responsible for the continui...

Location

Malta , Marsa

Salary:

44800.00 EUR / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (Chemistry/Biology/Pharmaceutics/Chemical Engineering) with 10+ years experience
Masters degree with 5+ years experience or PhD with 1+ year experience
Relevant experience is preferably in the pharmaceutical industry with a broad background in solutions/drug development/lifecycle management
Good knowledge of: Product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service
Design Control documentation and process
Statistical Analysis and/or Lean/Six Sigma tools
International/regional/national regulations and standards
Self-motivated, resourceful, and flexible
A self-starter is imperative
Strong interpersonal communication skills and ability to communicate effectively with internal and external customers

Job Responsibility

Lead a team of scientists responsible for the management and execution of lifecycle design supporting activities for the Clinical Nutrition Solutions On-Market products
Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc
Ensure that personal and team objectives align with key Segment initiatives
Manage routine and complex supplier notice of changes (SNCs), change control records, product code obsolescence and product end of life (EOL) activities in addition to general technical administrative tasks
Organize, plan and execute product changes in compliance with international regulations and quality standards
coordinate and set up cross-functional team meetings to ensure change execution, problem-solving and decision making
Independently plan, execute, and manage project(s) that span multiple disciplines with team, cross functions and regions
Employ project management tools to manage project schedules and budgets against milestones
review and apply best-demonstrated practices, team processes, and improve operational efficiency
Identify and resolve issues that may jeopardize project schedules and/or improve project timelines

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Competitive benefits
Discretionary bonuses
Long-term incentive

Fulltime

Senior Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Project Manager R&D

The Senior Project Manager – Surgical Tools and Technologies leads complex, cros...

Location

United States , Deerfield

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations

Job Responsibility

Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

R&D Knowledge and Learning Senior Manager (Content Development)

As a Senior Manager – TA/Product Knowledge & Learning (Content Development), you...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree with 10+ years of clinical/scientific affairs experience
Master’s degree with 12+ years of experience
Bachelor’s degree with 15+ years of experience
Strong experience in learning content development, visual storytelling, and instructional design
Proven ability to create infographics and visually compelling learning assets
Excellent scientific writing, editing, and presentation skills
Experience supporting global stakeholders in a matrixed environment
Strong project management and attention to detail

Job Responsibility

Support U.S. Senior Managers (Product/TA Learning Leads) by developing learning content aligned to product strategy and learning objectives
Work closely with the global K&L Sr Managers to create new learning materials while also refreshing and updating existing content
Design and develop a wide range of learning materials, including: Slide decks, facilitator guides, and participant materials, Infographics, visual summaries, and quick-reference tools, Content to support congress-related trainings
Translate complex scientific, clinical, and product information into clear, concise, and visually engaging content
Apply adult learning principles and instructional design best practices to enhance learner engagement
Incorporate interactive elements to support learning calls and virtual learning sessions
Manage content development timelines, version control, review cycles, and documentation
Review and edit content to ensure scientific accuracy, consistency, compliance, and alignment with Amgen standards
Incorporate feedback from U.S. Senior Managers and learners to continuously improve content quality
Maintain organized repositories of approved learning content and updates

GCP Quality Compliance Manager

In this vital role you will provide proactive end to end quality support for the...

Location

United Kingdom , Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong experience in GCP within Clinical R&D, Quality, or Study Management environments
Knowledge of electronic Quality Management Systems (e.g., Veeva, TrackWise) and clinical trial oversight processes
Solid understanding of clinical development, protocol execution, regulatory submissions, and inspection management
Proven ability to support operational and quality oversight of clinical trials from development through submission
Excellent written and verbal communication skills, including business writing and stakeholder engagement
Strong analytical, critical-thinking, and problem-solving capabilities with the ability to simplify complex processes and technical concepts
Background in Quality Management/Assurance and risk-based quality approaches within the pharmaceutical or biotech industry is preferred
Degree educated

Job Responsibility

Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program, including protocol development, database lock, and regulatory submissions/ approvals
Oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials
Serve as the GCP quality SME, providing independent quality guidance for clinical trial activities aligned with global regulations and best practices
Oversee quality and compliance across all stages of clinical development programs, including risk management through RACT and protection of patient safety, rights, and data integrity
Support clinical trial teams with quality management activities such as deviations/CAPAs, inspection readiness, serious breaches, privacy issues, and regulatory inspection responses
Review protocols and trial processes to drive simplification, apply lessons learned, and identify critical data and operational risks
Implement innovative, risk-based quality oversight approaches using advanced analytics, AI, and NLP methodologies
Monitor and analyze quality metrics and trends, identify gaps, and recommend corrective and preventive actions to stakeholders and senior leadership
Provide vendor quality oversight and support regional compliance with local regulations and regulatory requirements
Plan, conduct, and report risk-based GCP audits, including investigator site, affiliate, and study-level audits

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Quality Compliance Manager

In this vital role you will report to the Japan Asia Pacific (JAPAC) Quality Com...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Good knowledge of Regulatory Submission and overall Inspection Management procedures expected by Japan Pharmaceuticals and Medical Devices Agency (PMDA)
Experience in supporting regulatory inspections by overseas authorities (e.g. FDA, EMA), at Sponsor, CRO, or investigator‑site level is preferred
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format

Job Responsibility

Review specific clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
Provide quality oversight and assess the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
Provide oversight for the development and implementation of Quality Plans specifically suited within Japan
Establish country level expertise to ensure quality and compliance to local regulations and international guidelines (e.g.: ICH GCP, WHO etc.)
Liaise with the Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g.: biomarker usage and imaging methods)
Collaborate on TA and Affiliate-specific Quality Assurance plans for application within the region
Support local Clinical Trial and global/local cross-functional teams for all quality management activities, including Issue Management, Risk Assessment, Inspection Readiness activities, Audits and Inspection Management activities
Prepare, analyze and communicate compliance metrics/trends on a periodic basis to key stakeholders and senior leaderships
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)

Fulltime

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R&D Clinical - Quality Compliance Senior Manager

Job Description

Job Responsibility

Requirements

What we offer

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