Inspection Readiness Manager Job at Amgen (Uxbridge)

Inspection Readiness Manager

In this vital operational quality role you will oversee the execution of high-qu...

Location

United States

Salary:

114745.00 - 143236.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Bachelor Degree in Life Sciences or RN or equivalent
7 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
Experience of, or oversight of global clinical trial conduct
Experience driving and leading process development and /or improvement
Experience as an Inspection, or Risk Manager, preferred

Job Responsibility

Oversee the execution of high-quality GCP & IVDR Inspection Readiness & Preparation
Own the Site Inspection Readiness & Preparation project management for all clinical trials and programs covering early, late, and observational programs
Participate in developing and implementing innovative cross-functional Inspection Readiness (IR), Inspection Preparation, and Operational Quality (OQ) initiatives
Own and lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management using tools, materials, apps and systems
Innovate continuous improvement in operational quality inspection readiness by identifying and acting on program, study and site quality incidents, trends and updating existing tools or creating new support materials, or workstreams
Lead, as appropriate, and collaborate with the IR Support Team on function specific GCP & IVDR IR, Study Health and Quality initiatives
Advisory role to the business in achieving Inspection Readiness Inspection, and a limited role in internal audits
Maintaining and managing IR SharePoint (SPO) site
Managing Regulatory Inspection Preparation folders and access
Supporting the Inspection Readiness & Operational Quality, Senior Manager

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Manager, Inspection Management

Location

United States , Cambridge

Salary:

130800.00 - 209400.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.
Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
Experience with inspection coordination and logistical planning for regulatory authority inspections.
Experience with work in the Regulatory Intelligence area.
Experience developing responses to regulatory authority inspection findings.
Experience working with CROs, vendors, and relationship management.
Leadership skills with ability to effectively organize and execute tasks
Ability to interact effectively with all levels within the organization.
Ability to work both independently and in a team environment.

Job Responsibility

Build and maintain strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.
Maintain in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.
Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.
Coordinate and manage inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.
Provide guidance and direction in development of responses to observations resulting from inspections of Moderna’s R&D programs.
Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
Lead and manage post-inspection lesson’s learned sessions, ensuring all actions are tracked to completion.
Contribute to and maintain inspection management plans, trainings, and strategies for the R&D Quality inspection management program.
Review and provide input into study team inspection preparation activities, storyboards, etc.
Collaborate with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

Engineering Manager – F&E Readiness

Amgen Dun Laoghaire (ADL) is developing a next-generation, technologically advan...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline)
Experience (typically 5+ years) in engineering roles within a cGMP biopharmaceutical manufacturing environment
Experience in developing strategies for new product introduction and new technology deployment
Strong knowledge of, Equipment lifecycle management, Maintenance and reliability systems, GMP compliance, validation, and regulatory expectations
Proven ability to lead, build and develop teams, including working cross-functionally and managing complex stakeholder environments
Project management, problem-solving and decision-making capability
Excellent communication and technical writing skills

Job Responsibility

Act as the F&E representative within the capital project team, ensuring site requirements are embedded in facility and equipment design
Provide technical input and review of design deliverables (layouts, P&IDs, URS, specifications, automation strategies, maintenance concepts)
Ensure alignment with Amgen global standards, corporate blueprints and site operational requirements
Partner with Global Engineering, CQV, Automation, Quality and Operations to ensure a fully integrated and operable facility design
Identify and mitigate operability, maintainability and reliability risks early
Define and develop the F&E readiness strategy, including: Maintenance strategy and asset lifecycle plans
Spare parts and criticality assessments
Reliability and performance frameworks (OEE, predictive maintenance)
Establish systems to ensure equipment reliability and lifecycle ownership aligned with site expectations
Drive implementation of predictive and preventative maintenance philosophies from design through operation

What we offer

competitive salary
comprehensive Total Rewards Plan including health, financial and career development benefits

Deli Manager

Our Mission: We believe food should be as joyful as it is safe. Our stores are m...

Location

United Kingdom , Little Budworth

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Proven experience managing a deli, bakery, or fresh food retail environment
Strong knowledge of food safety legislation, HACCP principles, and allergen management
EHO auditing experience or Level 4 Food Safety qualification (or equivalent)
A creative eye for product presentation and merchandising
Excellent leadership skills with the ability to motivate and develop a diverse team
Strong organisational skills and a proactive, hands-on approach

Job Responsibility

Lead day-to-day operations of the deli and bakery, from production planning to merchandising
Help develop seasonal menus and product ranges that balance creativity with profitability
Train, coach, and inspire a team to deliver exceptional service and consistent quality
Conduct internal EHO-standard audits across food preparation, storage, and service areas
Maintain and update HACCP documentation, allergen registers, and cleaning schedules
Liaise with suppliers to ensure ingredient quality, traceability, and compliance
Monitor waste, stock levels, and margins to meet financial targets
Act as the point of contact during official EHO inspections, ensuring readiness at all times

What we offer

Competitive salary
Staff discount
A supportive culture that values both creativity and compliance

Fulltime

Senior Admin & Facilities Officer

We are looking for a Senior Admin & Facilities Officer to oversee the day-to-day...

Location

Philippines , Makati City

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Minimum 6 years of experience in Administration, Facilities Management, Workplace Operations, Office Management, or similar roles
Experience managing vendors, contractors, and external service providers
Experience overseeing office operations within a corporate environment
Proven experience creating and maintaining documentation, SOPs, workflows, and operational controls
Strong project coordination and stakeholder management experience
Amendable to work 3x a week onsite in our RCBC Ayala, Makati City office

Job Responsibility

Oversee the day-to-day operations of the Manila office, ensuring facilities remain safe, functional, organized, and employee-ready
Manage office maintenance, repairs, housekeeping, security, access controls, parking, and workplace services
Conduct regular workplace inspections and proactively identify operational risks and improvement opportunities
Coordinate office asset management, inventories, storage areas, and workplace resources
Ensure office-related issues are resolved promptly and effectively
Monitor office utilization trends and recommend improvements to workspace allocation, seating arrangements, meeting rooms, collaboration spaces, and workplace design
Lead office improvement, refurbishment, and workplace enhancement projects
Drive initiatives that improve employee experience, workplace efficiency, and operational effectiveness
Support workplace planning aligned with organizational growth and evolving business needs
Coordinate and implement ESG initiatives aligned with the Company's sustainability objectives

Head of Assurance

The Head of Assurance leads the development, implementation, and ongoing enhance...

Location

United Kingdom , Birchwood

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Significant experience within Assurance, Risk, Compliance, Financial Crime, Internal Audit, or related control functions within a regulated environment
Strong understanding of UK Gambling Commission regulatory requirements and expectations
Deep knowledge of financial crime risk management, including AML, fraud, sanctions, and customer risk controls
Proven experience developing and implementing assurance or oversight frameworks
Experience delivering risk-based assurance reviews and assessing control effectiveness
Strong understanding of governance, risk, and control frameworks
Excellent analytical, investigative, and problem-solving capabilities
Strong written and verbal communication skills with the ability to influence senior stakeholders
Ability to operate effectively in a fast-paced and highly regulated environment
High levels of integrity, professionalism, and sound judgement

Job Responsibility

Design, implement, and continuously enhance Betfred’s enterprise wide Second Line Assurance Framework
Develop and maintain a risk-based assurance plan aligned to regulatory, financial crime, operational, and conduct risks
Establish consistent assurance methodologies, standards, reporting, and governance across the organisation
Ensure assurance activities are proportionate, data-driven, and aligned to regulatory expectations and industry best practice
Define assurance coverage across key regulatory obligations, controls, policies, and processes
Coordinate assurance activities to minimise duplication and maximise insight across Risk, Compliance, and Internal Audit functions
Provide independent oversight and assurance over compliance with UK Gambling Commission Licence Conditions and Codes of Practice (LCCP)
Lead thematic reviews and deep-dive assurance assessments across key regulatory risk areas
Assess the design and operational effectiveness of regulatory controls and governance arrangements
Monitor emerging regulatory developments and ensure assurance activity evolves in line with changing expectations

Formulation Technician

The Formulation Technician is responsible for the strategic planning of the assi...

Location

United States , Marion

Salary:

44000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

High School Diploma or GED and must be at least 18 years of age
One year of manufacturing experience preferred
CRC (Career Readiness Certification) at the Silver Level preferred
Basic English written and oral communication skills adequate to communicate with other team members
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Ability to perform basic mathematics
Possess or be able to obtain PIT Operator Certification
Basic computer skills
Requires continuous firm grasping and pushing/pulling up to 50 pounds
Lifting and carrying on average up to 50 pounds continuously and up to 75 pounds occasionally throughout the shift

Job Responsibility

Responsible for proper formulation of tanks including weighing, labeling, staging materials with strict adherence to procedures and standardized formulas
Inspect, clean and re-palletize raw materials received from the warehouse
Take ownership of Mixing and Tank Rooms to ensure adherence to cGMPs
Perform routine preventative maintenance in the Mixing Complex
Promotes a culture of safety in the area
Investigate, identify, and correct or escalate any inefficiency’s or quality concerns for Mixing equipment and processes
Generate and implement continuous improvement activities to the Mixing area and process
Use a powered industrial truck (PIT) to transport staged materials to the assigned mixing tank
Pump or manually blend raw materials into a chemical solution mixing tank
Perform and document scheduled cleaning activities which include using a ladder and safety harness to climb into mixing tanks in order to clean the inside of the vessel

What we offer

Shift flexibility to trade shifts and leverage overtime opportunities
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Flexible Spending Accounts
educational assistance programs

Fulltime

Customer Service - Self Storage Manager

Our Property Managers get to work independently at multiple locations; spending ...

Location

United States , Grand Prairie

Salary:

15.00 USD / Hour

Public storage

Expiration Date

Until further notice

Requirements

Successful candidates come from a variety of customer service centered sales environments including retail, restaurant, fast food or other service-based companies
Our employees are required to have a valid driver’s license and utilize their own vehicle to travel between different work locations and/or while conducting other work-related business.
Ability to transport lift/move items weighing up to 35 pounds
Our property managers should be able to walk in/around facilities spending up to 50% of their time in outdoor environments, including climbing stairs and opening large doors.
Performing cleaning and daily maintenance tasks: including sweeping/mopping interior areas and maintain exterior grounds/curb appeal clean and free of debris.

Job Responsibility

We assess customer storage needs and make suggestions, including selling packing and moving supplies
Daily storage unit inspections to confirm inventory and availability helps make sure spaces are ready to rent
Auditing cash drawers and making bank deposits are part of the daily business
We help keep our customers current with payments and make reminder and collection calls when required

What we offer

Medical
Dental
Vision
401k with match
paid time off
sick time
flex spending
Company paid life
accidental death insurance
exclusive vendor discounts

Fulltime

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Inspection Readiness Manager

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