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

Tmf study owner

The TMF Study Owner provides pivotal support and subject matter expertise (SME) ...

Location

United States , Remote

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree level education preferred, but equivalent work experience in a relevant field considered
5 years’ relevant industry experience in Clinical or TMF Operations oversight
Excellent knowledge of Good Documentation Practices (GDP) and document recognition
Good knowledge of referencing/applying applicable resources
Working knowledge of: Clinical trial lifecycle, TMF Reference Model (or equivalent), eTMF systems, TMF Health & Metrics, including Quality Review process, Internal communication/escalation pathways
Familiar with: TMF lifecycle, Other clinical/document management systems, TMF stakeholders, End-to-end tasks, including TMF set-up process and Management Plans, TMF training, Inspection Readiness, External communication/escalation pathway
Proficient in verbal and written communication

Job Responsibility

Document Management & Quality: Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices
TMF Management: Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements
Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented
Monitor milestones and events to ensure TMF Completeness via eTMF functionality
Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team
Support study team through closeout and archive preparations
Ensure ongoing adherence to TMF SOPs and specifications
Create study-specific TMF Index (or equivalent)
TMF Health & Metrics: Perform and/or support Quality Review and perform spot-checks for quality oversight
Provide TMF Health status updates and review metric reports outputs on a recurring basis, with guidance on improving and maintaining

What we offer

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day
In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more

Fulltime

Cathodic Protection Engineer

The CP Engineer would work in the Surface Technical department in the integrity ...

Location

Iraq , basrah

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Bachelor’s in engineering, preferably Electrical /Mechanical/Materials or metallurgy – with good academic background
Experience in Cathodic Protection for onshore assets specially with Impressed current systems
7-10 years + of relevant experience in CP activities
Certification to NACE CP2/3 for cathodic protection desired
Willing to spend 40-50% time in the field

Job Responsibility

Cathodic Protection System Management: Lead the development, implementation, and management of cathodic protection systems for cathodically protected assets to prevent external corrosion and ensure asset integrity
Site Visits and Inspections: Conduct regular site visits and inspections to assess the performance and condition of cathodic protection systems, identify corrosion-related issues, and troubleshoot problems as they arise
Supervise the team of CP technicians and allocate the work to them on day-to-day basis
Manage the CP Contractor activities
Development and Maintenance of Asset register: Maintain a current and accurate inventory of Piping, tanks, pipelines, flowlines and their respective inspection records viz. potential measurements and current measurements
Design and Installation: Provide technical expertise in the design, specification, and installation of cathodic protection systems for new and existing assets, ensuring compliance with industry standards and best practices
Performance Monitoring: Continuously monitor the performance of entire ICCP cathodic protection systems, analyze the data and make adjustments as necessary to maintain optimal system performance
Compliance and Documentation: Ensure that all cathodic protection activities comply with clients design intent, relevant industry standards, regulations, and environmental requirements. Maintain accurate records and documentation of system performance and maintenance activities
Technical Advising: Collaborate with cross-functional teams, including Integrity engineers, corrosion engineer, maintenance personnel and operations personnel, to provide technical guidance and recommendations related to corrosion control with cathodic protection
Troubleshooting: Respond to and resolve cathodic protection-related issues viz. interference with other assets and coordinate with them for resolution

Fulltime

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 Affairs Lead

The Quality Affairs Lead exists to build and own a lean, scalable Quality Manage...

Location

United States , Plymouth

Salary:

Not provided

Blackrock Neurotech

Expiration Date

Until further notice

Requirements

Deep expertise in medical device Quality Systems (QMS) and design controls for Class III devices
Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
Hands-on experience with DHF management, traceability, verification & validation
Supplier quality management, audits, and Quality Management Agreements (QMAs)
Inspection readiness, CAPA, nonconformance management, and internal auditing
Familiarity with IDE/PMA requirements and supporting regulatory submissions
Working knowledge of IEC 60601, IEC 62304, and ISO 10993
10+ years in medical device quality or quality/regulatory or Quality Engineering roles
Direct experience with Class III and implantable devices (ideally neuromodulation)
Proven track record owning design controls and DHF in product development

Job Responsibility

Own and execute Adraxe’s quality strategy by building and maintaining the QMS
Lead design controls and DHF integrity
Embed risk management across product development and clinical activities
Solve complex challenges around maintaining compliance without slowing execution
Manage quality across external partners
Prepare the company for FDA scrutiny and IDE/PMA milestones
Key initiatives include QMS build-out, IDE readiness, supplier qualification and QMAs, risk management implementation, and inspection readiness
Establish scalable post-market systems
Work cross-functionally with Engineering, Clinical, and Regulatory teams
Partner closely with leadership

Fulltime

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

Make Ready Technician

Bay Property Management Group is seeking a Make Ready Technician, assigned to pr...

Location

United States , Baltimore

Salary:

17.00 USD / Hour

Bay Property Management Group

Expiration Date

Until further notice

Requirements

High School Diploma
1-2 years experience as Make Ready Technician required
Able to read, write, and speak English
Spanish a plus
Plumbing certification preferred, but not required
Valid driver’s license and clean driving record
Able to utilize work order tracking system on multiple devices, such as a phone, tablet, or laptop
Exceptional communication skills both written and verbal
Knowledge of common maintenance issues in residential units
Exceptional time management skills

Job Responsibility

Process and fulfill work orders for a variety of maintenance issues including, but not limited to paint, filter changes, garbage disposals, door/window repairs, towel bars, vanities, caulk work, screens, bulbs, smokes/co’s, blinds, drip pans, weather stripping, screen doors, concrete patches, floor installs, toilet/sink repairs, and other general handyman services
Move out and routine property inspections using AppFolio inspections
Providing estimates for and turning over vacant units to prepare them for new tenants (including full paint, as needed)
Maintain invoices, work orders, and timesheets for jobs
Balance schedule that fluctuates constantly
Complete work quickly and efficiently to control costs for owners
Company credit card use and receipt management

What we offer

401k with company match
Employee-paid health insurance
6 paid holidays, and 15 PTO days (after 90-day probationary period)

Select Country

Inspection Readiness Manager

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?