Capa Lead Job at Office Angels (Folkestone)

Sr Principal Engineer - Software Quality

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

United Kingdom , Gloucester

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor of Science or Bachelor of Engineering in Software Engineering, Computer Science, Electrical, Biomedical, or related discipline required. Master’s degree or PhD preferred with 10+ years of progressive experience in software quality engineering, including regulated medical device software and/or digital health platforms
Strong expertise in: ISO 13485 Quality Management Systems
EU MDR (Regulation (EU) 2017/745) and software implications
Software lifecycle standards (e.g., IEC 62304, IEC 82304 where applicable)
FDA software and quality system expectations
Proven ability to integrate Agile development practices with regulatory compliance, including traceability, documentation, and change management
Broad understanding of: Software architecture and system integration
Cloud-based systems, cybersecurity, and data privacy considerations
Software risk management, including hazard analysis and vulnerability management
Strong technical leadership with advanced problem-solving, analytical, and decision-making skills

Job Responsibility

Lead and govern activities that ensure alignment with Baxter’s Product Lifecycle Management (PDLM) and Change Control Management (CCM) processes and compliance with design controls and quality system regulations
Translate Agile software development practices into compliant frameworks that meet Baxter, ISO 13485 and EU MDR expectations, including traceability, documentation, verification, and validation
Ensure effective implementation of software design controls, including: Software requirements and architecture
Risk management (software hazard analysis, cybersecurity risk)
Verification and validation strategies (manual, automated, CI/CD pipelines)
Configuration and change management
Lead integration of Quality Management System (QMS) processes into software development workflows, including: CAPA and nonconformance handling
Complaint handling and feedback loops into Agile backlogs
Audit readiness and inspection support
Ensure compliance with EU MDR requirements, including: Support for technical documentation and software lifecycle evidence

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Senior Director, Quality Assurance

Theradaptive is revolutionizing the field of therapeutic delivery with a pipelin...

Location

United States , Frederick

Salary:

Not provided

Theradaptive

Expiration Date

Until further notice

Requirements

Bachelor's degree (required) in Life Sciences, Biomedical Engineering, Chemistry, Biochemistry, or a related field
Advanced degree (M.S., Ph.D., or M.D.) strongly preferred
15+ years of progressive quality experience in the biopharmaceutical, biotech, or medtech industry, with at least 5 years in a senior leadership role (Director level or above)
Demonstrated experience with combination products, including working knowledge of both drug/biologic and device QMS frameworks
Direct experience managing FDA inspections (PAI, cGMP, QSR) and responding to 483 observations and Warning Letters
Hands-on experience with protein biologics or growth factors (e.g., rhPDGF, BMP, FGF, EGF, VEGF) in a GMP manufacturing or quality context
Experience with sterile or aseptic combination products is highly preferred
Expert-level knowledge of: 21 CFR Parts 210/211 (Drug cGMP), 21 CFR Part 820 / ISO 13485 (Device QMS), 21 CFR Part 4 (Combination Products)
Expert-level knowledge of: ICH Q7, Q8, Q9, Q10, Q11 guidelines
Expert-level knowledge of: ISO 14971 (Risk Management), ISO 10993 (Biocompatibility)

Job Responsibility

Design, implement, and own an integrated QMS that satisfies 21 CFR Parts 210/211 (drug/biologic GMP), 21 CFR Part 820 / ISO 13485:2016 (medical device QMS), and ICH guidelines (Q7, Q8, Q9, Q10)
Ensure the QMS addresses the regulatory designation of the combination product (PMOA-based lead center: CDRH or CDER) and the requirements of the non-lead center
Develop and maintain all quality policies, SOPs, work instructions, and quality plans across the product lifecycle
Drive QMS digital transformation initiatives, including electronic quality management platforms (e.g., Veeva Vault QMS, MasterControl, TrackWise)
Serve as the company's subject-matter expert on 21 CFR Part 3 (combination product designation), 21 CFR Part 4 (regulation of combination products), and applicable guidance documents
Lead cross-functional efforts to align quality requirements for both the protein growth factor drug/biologic constituent and the device constituent part throughout CMC development, scale-up, and commercialization
Oversee the integration of device design controls (21 CFR 820.30) with drug development quality requirements, ensuring alignment in risk management activities per ISO 14971
Collaborate closely with Regulatory Affairs on BLA, PMA, 510(k), or De Novo submission strategies — specifically quality module content (Module 3 / CTD, Design History File, Device Master Record)
Prepare and lead quality-related FDA interactions including pre-submission meetings, Agency responses, and inspection readiness activities
Support compliance with EU MDR 2017/745, IVDR, and country-specific registration requirements for international expansion

Senior Clinical Research Associate - Oncology

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing...

Location

United States , Washington DC

Salary:

110520.00 - 138150.00 USD / Year

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree (scientific field preferred)
5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits
At least 2 years monitoring solid tumor clinical trials
1+ years early development trial experience
Solid tumor clinical trial experience is required
Experience utilizing Veeva systems is highly preferred
Demonstrated experience developing/maintaining site relationships and securing compliance
Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
Experience collaborating with sites from initial engagement through close-out phases
Experience activating sites

Job Responsibility

Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
Promptly document monitoring activities and submit/approve visit reports
Manage site essential document collection and TMF reconciliation with site files
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Quality Associate-I, QA Assurance

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering / ASQ certification, other Quality Certification preferred or Combined Equivalent in Work Experience.
Minimum 3 Years of experience required
Manufacturing and quality background
Previous experience in a GMP environment
Knowledge of cGMP, ISO, and Regulatory standards
Detail oriented with the ability to work under pressure
Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
Ability to build strong relationships and partner with internal and external stakeholders.
Strong ability to balance multiple priorities.
Strong analytical and problem-solving skills with critical thinking abilities.

Job Responsibility

Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality
Support on assigned shift, with requirement to support plant overtime and planned shutdowns when applicable
Provide technical support on review/approval of department related procedural changes product quality issues, reinspection, new product introduction and Protocols
Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented
Support timely follow-up on quality exceptions and their preventative/corrective actions
Support initiation/investigation and approvals of non-conformance events in the Trackwise system
Support release process by performing final release of products to distribution by ensuring product conforms to specifications, SOPs and regulatory requirements
Support Quality IT Systems (SPC Infinity, EBR, BMTCS, etc.)
Ensure control of defective WIP materials (quarantine, retention and disposal areas) to ensure adequate segregation, movement, documentation and timely follow-up within the plant to comply with Regulatory and Compliance requirements
Ensure shop floor presence by performing process walkabouts and supporting operations to remediate issues that are identified

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

QA Validation & Projects Manager

We are recruiting a QA Validation & Projects Manager to provide quality and vali...

Location

United Kingdom , Guildford

Salary:

Not provided

Alliance Medical Ltd

Expiration Date

Until further notice

Requirements

A degree (or equivalent experience) in validation, quality or a related pharmaceutical discipline
A strong background in validation, ideally with 5+ years' experience in a pharmaceutical, radiopharmacy, sterile manufacturing or aseptic processing environment
Proven QA and validation experience within GMP-regulated manufacturing
Demonstrable experience supporting commercial products and IMP development
Strong working knowledge of UK and EU GMP, MHRA requirements and wider GxP compliance
Experience working across multi-site operations and implementing consistent quality standards
Experience supporting regulatory inspections, audits and authority interactions
Previous managerial or supervisory experience, with a track record of motivating and influencing teams
Excellent written and verbal communication skills with the ability to engage at all levels
Strong organisational skills, attention to detail and the ability to work proactively and independently

Job Responsibility

Providing QA and validation leadership across all UK Radiopharmacy facilities
Acting as the QA Validation lead for both commercial and IMP activities
Overseeing and harmonising validation activities across multiple sites, including deviations, change control, CAPAs, documentation and risk management
Acting as a subject matter expert for validation and advising site teams on projects and continuous improvement initiatives
Supporting MHRA and regulatory authority inspections, audits and responses, ensuring ongoing compliance commitments are met
Reviewing and approving quality and regulatory documentation, including SOPs, batch documentation and validation protocols
Providing QA input into product development, technology transfer and validation activities within sterile and radiopharmacy environments
Supporting the implementation of new electronic Document and Quality Management Systems
Contributing to Global Quality Management meetings and tracking actions to completion
Coaching and mentoring QA project teams and site stakeholders, acting as a role model for quality and compliance

Fulltime

Senior Manager Pharmacovigilance Operations

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree and 14 years of pharmaceutical, biotech or regulatory authority experience or relevant experience in a research and development setting
Health Care/Life Sciences Professional with minimum 12 years of relevant work experience including 5 years of experience in people management
Extensive people management experience
Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
Understands and interprets data/information and its practical application
Excellent English written/oral communication, and strong time and project management skills
strategic mindset, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations
Demonstrate knowledge of global aspects of pharmacovigilance
Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting
Ability to effectively manage competing priorities and timelines

Job Responsibility

Supervision of a team of Literature Specialists responsible for performing routine weekly review of literature articles retrieved from Embase, Medline, and BIOSIS
Establish and maintain governance frameworks for literature review, search strategy management, quality and compliance oversight, systems and operational support
Ensure consistent achievement of internal/external SLA/TAT commitments
Oversee workflow management, mailbox operations, ancillary activities
Monitor and optimize queue volumes and ageing, productivity and utilization, vendor performance
Oversee quality framework including QC processes and error monitoring, CAPA management and closure, trend analysis and risk mitigation
May perform retrospective quality checks on the quality of the literature review performed by team
Business process owner for global literature review process and literature management systems
Drive initiatives to improve throughput and cycle time, optimize cost and resource utilization, reduce manual effort through automation
Lead cross-functional improvement programs

Fulltime

Senior Quality Engineer

10x Genomics was founded to deliver powerful and reliable tools that fuel key sc...

Location

United States , Pleasanton

Salary:

132800.00 - 179600.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Biology, Biochemistry, Chemistry, Bioengineering, Chemical Engineering, or Mechanical Engineering
7 years of experience in supplier quality engineering in the life sciences industry, specifically supporting complex consumables and reagents
Proven experience in conducting supplier audits, managing corrective and preventive actions (CAPA) and supplier corrective action requests (SCARs), and implementing quality systems and processes
Fluency in GD&T (ASME Y14.5 1994, 2009, & 2018) and the ability to read mechanical drawings, specifically for consumable plastic parts
In-depth knowledge of regulatory requirements and industry standards (e.g., ISO 9001, ISO 13485, FDA/GMP)
Strong analytical and problem-solving skills, with a track record of driving quality improvements and operational excellence
Excellent communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels

Job Responsibility

Supporting the selection of new suppliers
Leading supplier quality audits
Monitoring the performance of our suppliers
Ensuring the timely closure of nonconformances
Eliminating systemic supplier quality issues
Improving the quality systems and processes of a world-class supplier quality program

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Competitive and comprehensive health benefits package
Competitive easy-to-use benefits that promote wellbeing
Family friendly policies like parental leave and other benefits
Generous time off

Fulltime

Sanitation Supervisor

The Sanitation Supervisor (First Shift, Saturday -Wednesday) is responsible for ...

Location

United States , Chicago

Salary:

71400.00 - 107200.00 USD / Year

Unilever

Expiration Date

Until further notice

Requirements

High School Diploma
2+ years of sanitation experience within a food manufacturing or regulated production environment
Proven leadership experience (1+ years) supervising hourly sanitation teams
Hands-on expertise with sanitation systems and processes including Master Sanitation Schedule (MSS), CIP/COP, and return-to-service validation requirements
Demonstrated experience working within GMP, HACCP, and food safety regulatory frameworks
Experience partnering cross-functionally with Operations, Quality, and Engineering teams

Job Responsibility

Lead execution of the Master Sanitation Schedule (MSS) to ensure full compliance with internal standards, GMPs, and regulatory requirements
Ensure all cleaning activities meet food safety expectations, preventing contamination risks across equipment and environment
Oversee CIP (Clean-in-Place) and COP (Clean-out-of-Place) processes to ensure proper sanitation of all product contact surfaces
Drive adherence to chemical handling, PPE usage, and safety protocols
Manage sanitation operations for assigned shift (Saturday–Wednesday schedule) to ensure production readiness
Own Return-to-Service (RTS) validation and release processes post-sanitation
Ensure timely and effective completion of sanitation tasks to support production schedules
Monitor sanitation effectiveness through inspections, audits, and verification programs
Lead, coach, and develop a team of approximately 13 hourly sanitation employees
Ensure proper staffing, training, and performance management to meet operational needs

What we offer

Health insurance (including prescription drug, dental, and vision coverage)
Retirement savings benefits
Life insurance and disability benefits
Parental leave
Sick leave
Paid vacation and holidays
Access to numerous voluntary benefits
Bonus eligible
Long-Term Incentive (LTI) eligible

Fulltime

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Capa Lead

Sr Principal Engineer - Software Quality

Senior Director, Quality Assurance

Senior Clinical Research Associate - Oncology

Quality Associate-I, QA Assurance

QA Validation & Projects Manager

Senior Manager Pharmacovigilance Operations

Senior Quality Engineer

Sanitation Supervisor

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