Quality Compliance Senior Manager Job at Amgen (Remote)

Senior Manager Quality Compliance External Affairs

The Senior Manager Quality Compliance External Affairs will enhance quality, com...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Minimum of 12-16 years of experience in pharmaceutical manufacturing / quality
Experience in working with and representing a company in external organizations
Ability to interpret, analyze, and communicate information, not simply summarize
To manage / lead multiple programs and/or projects
Understanding of global regulatory Quality requirements (incl. GxP, Supply chain, Medical Device / Combination products, Pharmacopoeia)
Knowledge in Pharmaceutical Quality Systems / Quality Management Systems
Proven ability to understand technical, scientific, and medical information
Involvement in external activities representing a company / agency
Computer and database skills

Job Responsibility

Representing Amgen in industry trade, individual based associations and/or academia
Networking with peers from other companies and regulatory authorities
Taking opportunities to lead teams in and represent for these external professional bodies and organizations
Communicating Amgen’s perspectives and knowledge to regulators, governments, associations, and academia
Support organizing educational site visits of regulatory / governmental officials
Supporting or leading the commenting on regulatory documents incl. pharmacopoeias
National and international travel required (up to 20%)
Networking across various Amgen functions
Answering day-to-day questions on regulatory trends and interpretation of regulatory documents
Providing training / education sessions to enhance the knowledge on regulatory and technical expectations

Fulltime

R&D Clinical - Quality Compliance Senior Manager

We are hiring a R&D Clinical Quality Compliance Senior Manager, who will operate...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s Degree in appropriate discipline e.g. Life Sciences, Medical
15-18 years’ experience working in Biotech, Pharmaceutical or CRO company
In-depth knowledge of ICH GCP
Extensive experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are core responsibilities
Experience using electronic QMS such as Veeva Vault and eTMF
Experience and understanding of Clinical R&D activities and Global Regulations
In-depth knowledge of the Regulatory Submission and Inspection readiness, preparation and management procedures
Extensive experience in Quality Oversight of Clinical Trials, including clinical trial protocol development and execution
Strong verbal and written communication skills, including strong business writing abilities and active listening
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Key advisor to the study team throughout the clinical trial life cycle, providing independent and objective quality input in the areas of GCP and compliance with Amgen SOPs and processes
Review and provide input into the development of the initial clinical study protocol and subsequent amendments, with focus on quality by design, confirming it’s fit for purpose, clear, concise and consistent
Actively provide input into study risk assessment activities
Review and provide input into other key study documents and plans
Direct study teams through the management of complex quality issues
Participate in key activities related to Risk Based Quality Management
Using available tools, analyze quality data metrics
Monthly meetings with study team lead/associate director, to review the following: on-going quality issues, quality trends, program filing timelines, inspection readiness, potential inspections and audit scheduling and planning and any other topics deemed relevant
Support the clinical study team with inspection readiness activities
Support continuous improvement initiatives within TA Quality

What we offer

Varied 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

Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Location

United Kingdom , Cambridge; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Experience in Quality Management, Quality Compliance or other relevant risk-based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
Previous experience supporting regulatory authority inspections of pharmacovigilance activities
Experience of leading and/or supporting process improvement initiatives
Previous leadership or mentoring experience is ideal

Job Responsibility

Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality
Ensure proactive identification of issues relating to processes, programs, and external relationships, escalate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation
Assess and manage risks including providing input into the development of the annual GPvP audit plan
Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers
Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information
Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs
Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers
Support inspections and external audits, including preparing, conducting, and closing out response reviews
Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews
Develop long-term remediations and process improvements through Root Cause Analysis (RCA)

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
Ability to work flexibly from home with occasional office work

Fulltime