Gcp Quality Compliance Manager Job at Amgen (Hyderabad)

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

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
Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
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
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

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

Fulltime

GCP Quality Auditor

In this vital role within R&D Quality you will be planning and participating in ...

Location

United Kingdom , Uxbridge; London; Edinburgh; Cambridge; Aberdeen

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Proven and extensive international auditing experience in GCP
Experience of data mining, manipulation and data analytics would be advantageous
Excellent written and verbal communication skills

Job Responsibility

Plan, conduct and report routine and directed GCP compliance audits internationally
Serve as a lead auditor for complex GCP audits
Identify and communicate compliance risks to R&D Quality management
Host and/or play a role in regulatory authority inspections
Contribute to or lead R&D Quality process improvement initiatives
Author and contribute to the development of R&D Quality cross functional controlled documents

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

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Gvp compliance lead

BioMarin is looking for an individual with experience working in Pharmacovigilan...

Location

United States

Salary:

176000.00 - 242000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.

Job Responsibility

Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

New

Asset Quality Lead, Director - FSP

The Asset Quality Lead (AQL) is responsible for driving GCP Quality by maintaini...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A scientific or technical degree is preferred
BS: 10+ years or equivalent
MS/MBA: 7+ years or equivalent
Ability to build strong network/knowledge/relationships with internal/external stakeholders
Strong, advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines
Familiarity with the relevant key therapeutic area(s)
Advanced clinical trials experience, especially operational processes and/or systems
Strong interpersonal skills, ability to influence, engage leaders and ability to establish and maintain excellent working relationships across lines in a matrix organization
Experience of working on global initiatives or project teams
Appreciation of diverse needs of different regulatory requirements of various sites and countries

Job Responsibility

Ensure clinical development plan strategy and asset-level risks are incorporated into study and asset level risk management and oversight to support GCP Compliance
Strategically, utilize quality measures/data to monitor asset/study quality and identify potential risks, quality trends, and support state of quality reporting
Communicate key quality information across study teams and serve as GCP quality expert to study teams
Monitor submission risk and flag major risks for Category Quality Head review and other key stakeholders for review
Oversee study-level quality risk management activities, including driving Study Risk Profile development/maintenance and QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner
Develop and present quality point of view at governance and portfolio related meetings
Provide Study Team Inspection Readiness(IR) guidance and support to asset teams and pivotal study teams that have a high likelihood of regulatory inspection
lead teams through pre-submission dive and storyboards
Develop and maintain inspection readiness tools and processes
In conjunction with IMQA, coordinate business line GCP inspection support activities including but not limited to requests for dossiers, pre-inspection requests, during inspections and through the development of written responses to findings

Quality Compliance Manager

We are hiring a Quality Compliance Manager, which will operate within the Genera...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of quality management experience
Bachelor’s degree and 4 years of quality management experience
Associate’s degree and 8 years of quality management experience
High school diploma / GED and 10 years of quality management experience
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 Track wise
Thorough understanding of Clinical R&D activities and Global Regulations
Knowledge of the Regulatory Submission and Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions

Job Responsibility

Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy
Provide independent and objective quality advice in support of clinical trial activities
Provide quality oversight for Amgen programs for all stages of products in clinical development
Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial
Support the establishment of regional expertise to ensure quality and compliance to local Regulations
Support Clinical Trial Teams for all quality management activities
Ensure TA-specific data integrity
Review clinical trial protocols
Actively seek and implement innovative and proactive quality oversight methodologies
Manage/support regulatory inspection and review responses

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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Quality Compliance Senior Manager

The role provides proactive end to end quality support for the development and i...

Location

Türkiye , Istanbul

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality Management, Quality Assurance and Good Clinical Practices experience in the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility
Master’s degree and 4 years of the previous mentioned experience
Bachelor’s degree and 6 years of the previous mentioned experience
Associate’s degree and 10 years of the previous mentioned experience
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
Thorough understanding of Clinical R&D activities and Global Regulations
Experience with Regulatory Submission and Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Leadership or mentoring experience is ideal, in a regional capacity would be phenomenal
Excellent verbal and written communication skills, including strong business writing abilities and active listening

Job Responsibility

Act as a Good Clinical Practice (GCP) Subject Matter Expert, offering independent, objective quality guidance
Oversee quality across all clinical development stages
Plan and execute risk-based GCP audits (sites, affiliates, vendors, studies)
Support regulatory inspections and guide responses, including root cause analysis and CAPAs
Lead quality oversight of Risk Assessment Categorization Tools (RACT) for each trial
Facilitate monthly quality risk reviews with clinical program leaders
Manage audit findings, deviations, and CAPA responses
Ensure regional compliance with local regulations and support vendor evaluations
Analyze data quality trends, identify gaps, and implement corrective actions
Oversee technologies for endpoint data collection (e.g., biomarkers, imaging)

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits
Flexible work arrangements

Fulltime

Gcp Quality Compliance Manager

Amgen

Location:
India , Hyderabad

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 06, 2026

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