Senior Specialist, QA External Manufacturing Job at Alfasigma (Pomezia)

Senior Quality Assurance Specialist

CK Group are recruiting for a Senior Quality Assurance Specialist to join a glob...

Location

United Kingdom , Uxbridge

Salary:

29.00 GBP / Hour

CK Group

Expiration Date

Until further notice

Requirements

Hold a relevant scientific degree or have equivalent working experience
In-depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
Ability to build relationships, partnerships and influence stakeholders
Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
Experience in interacting with external manufacturers and supporting quality at external manufacturing sites
Hold entitlement to work in the UK

Job Responsibility

Responsible for QA vendor oversight
Manage contractor quality assurance activities
Identify and recommend quality-related improvements
Manage change control requests
Review batch records
Support GMP/GDP site inspections

Fulltime

Senior QA Specialist (CMO Oversight)

Join our client with this QA position and play a key role in maintaining top-tie...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong knowledge of cGMP/GDP regulations for the USA, EU, and international markets
Ability to balance business targets with scientific and quality decisions
Excellent analytical, problem-solving, and project management skills
Strong communication and organizational abilities
Experience in developing and executing pharmaceutical quality systems
Proficiency in computer systems
Degree in a scientific discipline (BSc or equivalent)
Technical expertise in chemical, biological, and/or pharmaceutical operations
Experience interacting with Health Authorities (e.g., FDA, EMA) and supporting inspections
Proven ability to manage quality at external manufacturing sites

Job Responsibility

Manage contractor quality assurance activities to ensure compliance with regulatory and corporate requirements
Build and maintain strong working relationships with contractors
Lead discussions on quality-related topics such as complaints, change control, deviations, and documentation
Recommend and oversee quality-related improvements at contractor sites
Review batch records, including master production-packaging records and executed batch records, for GMP compliance
Manage and monitor change control requests, including evaluation, approval, and progress tracking
Support and approve complaint investigations related to external vendors
Review, edit, and approve contractor documentation, including validation protocols, reports, and investigations
Lead the review of Annual Product Quality Review reports and negotiate improvements with contractors
Draft, review, and recommend approval for Quality Agreements

New

Senior Quality Engineer

Be part of something altogether life-changing! Working at Cytiva in the Life Sci...

Location

United Kingdom , Newquay

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

Ability to lead others when working within a cross functional team
Logical, inquiring approach to work
Must be motivated and able to work to deadlines
Ability to work without supervision, using own initiative, prioritising work as appropriate whilst maintaining a cross-functional team approach
Able to make reasoned and objective decisions where necessary and communicate these in an effective manner

Job Responsibility

Support and Lead the operations teams and Engineers when required in the evaluation, trending and reporting of internal and external non-conformances to establish priorities and identify common threads aimed at a continuous reduction in internal non-conformance occurrences via internal or supplier process improvements
Develop, Manage and maintain the development plans for the Quality Engineers in QA
Actively review the production environment identifying non-conformity, areas to improve compliance
Coordination and reporting of relevant failure investigations and subsequent corrective and preventive actions and reviewing effectiveness of these
Work with the Engineers to collect, analyse, trend and report data on rejects from routine production inspection and QC tests and related processes to establish improvement priorities and identify common threads aimed at a reduction in external complaints
Work with QA Specialists and others as appropriate to ensure that production inspections and QC tests are aligned with customer needs

Senior Specialist Quality

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

Location

United States

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of quality compliance experience
Master’s degree and 4 years of quality compliance experience
Bachelor’s degree and 6 years of quality compliance experience
Associate’s degree and 10 years of quality compliance experience
High school diploma / GED and 12 years of quality compliance experience
Background in Quality, QC, QA, Engineering desirable
Understand quality documentation and laboratory practices including general methodologies, specifications and product quality standards
Excellent communication skills for both internal conversations and when representing Amgen at external forums
Conflict resolution
Teamwork and Networking

Job Responsibility

Lead project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring structured review and implementation of periodic updates
Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines
Ensure all pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a current state within Amgen systems
Author compendial assessments within Amgen’s documentation management systems for audit readiness purposes
Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia matters
Represent Amgen’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial public standards
Liaise with regulators through industry associations, supporting advocacy and alignment efforts
Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes
Support knowledge-sharing across functions to enhance understanding of external landscape developments
Provide back-up support within External Affairs as needed to ensure business continuity

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

Senior Specialist, Quality Assurance

Serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Suppl...

Location

United States

Salary:

149651.00 - 168146.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of Quality Compliance experience
Master’s degree & 4 years of Quality Compliance experience
Bachelor’s degree & 6 years of Quality Compliance experience
Associate’s degree & 10 years of Quality Compliance experience
High school diploma / GED & 12 years of Quality Compliance experience
Bachelor’s degree in Life Sciences or Engineering
Experience leading or participating in key roles for Regulatory/Health Authority inspections
Experience auditing and defending processes/procedures during inspections
7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management

Job Responsibility

Own and lead the SQM/GSQ inspection readiness processes
Provide strategic and tactical leadership for inspection and audit preparation, execution, and response
Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites
Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates
Maintain and continuously improve inspection readiness processes
Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and internal audits
Drive proactive identification, communication, and resolution of site and cross-functional compliance risks
Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation
Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation

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 where possible

Fulltime

Senior QA/RA Specialist

The primary role of Quality Assurance function is to ensure that management syst...

Location

United Kingdom; Ireland , Harrogate; Dublin

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Bachelor's degree (technical or software background preferred) from four year college or university
at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
four (4) to five (5) years related experience or equivalent education and experience
Strong experience or exposure across Quality Systems (ISO 13485) / Design and Development of Medical device software (IEC 62304 environment)/ Supplier quality / Medical Device Regulation (MDR 2017/745)
Good Knowledge of ISO 13485 standard and Medical Device Regulation (MDR 2017/745)
Ability to exercise judgment
Good communication, planning and organizational skills
Proactive
able to provide initiative, ownership while working through uncertainty
Self-starter, with the ability to work with minimal supervision and with a sense of urgency

Job Responsibility

Role of Management Representative (ISO 13485)
Ensure the processes needed for the Quality Management System are effectively defined, documented, implemented and maintained
communicate and report on the performance and effectiveness of the QMS and any need for improvement to the senior management team and all other company personnel
Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
Coordinate and execute to support QMS activities
Ensure complaint handling / investigations, CAPA, Nonconformities, are processed and resolved in a timely manner
Suppliers’ management (including evaluation, monitoring, quality agreements)
Design and Development activities
Change control
Internal / external / supplier audits

What we offer

All employees benefit from a bonus plan
Working from home flexibility
Access to a referral bonus
Access to ResMed's preferred shareholding programme
Internal career opportunity

Fulltime

New

Attorney

We are looking for an attorney with employment experience to join a tenured, gro...

Location

United States , San Diego

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Active license to practice law in the state of California
Proven experience in civil litigation, particularly employment law and class action defense
Strong skills in drafting motions, pleadings, and legal briefs
Proficiency in conducting depositions and managing discovery processes
Solid understanding of California labor laws and federal employment regulations
Ability to handle multiple cases simultaneously while maintaining high attention to detail
Excellent communication skills for client interactions and courtroom presentations
Commitment to meeting billable hour requirements and adhering to deadlines

Job Responsibility

Manage employment litigation cases from initiation through trial, ensuring thorough preparation and strategic execution
Participate in defending large class action lawsuits alongside firm principals and senior attorneys
Conduct depositions and court appearances as part of discovery and case proceedings
Draft and file pleadings, motions, and legal briefs with attention to detail and compliance
Represent clients effectively in hearings and other courtroom settings
Maintain clear and detail-oriented communication with clients, insurance carriers, and opposing counsel
Meet monthly billable hour requirements of 130 hours, demonstrating efficiency and dedication
Collaborate with the firm's transactional group on employment-related matters as needed
Stay updated on California and federal labor laws to provide informed counsel
Contribute to the firm's positive and stable work environment through teamwork and reliability

What we offer

medical
vision
dental
life and disability insurance
company 401(k) plan

New

Cloud Solution Architect-Security

We are looking for a highly motivated and passionate Security Cloud Solution Arc...

Location

United States , Multiple Locations

Salary:

85100.00 - 169800.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Computer Science, Information Technology, Engineering, Business, Liberal Arts, or related field
2+ years experience in cloud/infrastructure technologies, information technology (IT) consulting/support, systems administration, network operations, software development/support, technology solutions, practice development, architecture, and/or consulting OR equivalent experience
U.S. citizenship
Ability to pass the Microsoft Cloud background check upon hire/transfer and every two years thereafter
Ability to obtain and maintain a United States Security Clearance
Technical experience designing, architecting, and implementing cloud security solutions
Experience with cloud-native security controls, threat detection and response platforms, and Security Information and Event Management (SIEM) systems
Skills in cloud infrastructure security architecture and secure deployment practices and integration of security technologies across a multi-cloud environment

Job Responsibility

Drive customer transformation on the Microsoft Azure Platform
Own the overall technical relationship and strategy between the customer and Microsoft
Own the Azure Security customer engagements, including architecture, implementation, and production
Lead in-depth technical security architecture discussions with senior customer executives, Enterprise Security Architects, Enterprise Architects, IT Management, and Developers
Land an end-to-end value prop for Security (i.e. Zero Trust, Modern Security Operations Center (SOC), Cloud Adoption, and Digital Transformation)
Empower customers in their Microsoft Security adoption journey, helping them to define a secure strategy, architecture, and implementation of necessary security controls
Perform hands-on activities, supporting the customer in evaluating native security solutions
Apply technical knowledge to architect security solutions that meet business, Information Technology, Regulation and Compliance needs
Ensure that the solution exhibits 'Secure by Design' or 'Well-Architected' framework
Run Architectural Design Session to build plan for implementing solution

Fulltime

Senior Specialist, QA External Manufacturing

Alfasigma

Location:
Italy , Pomezia

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 22, 2026

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Senior Specialist, QA External Manufacturing

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Location:Italy , Pomezia

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Contract Type:Not provided

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Job Posted:March 22, 2026

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