Quality Systems & Laboratory Manager Job at Quintessential Brands Group (Warrington)

Manager, Quality Systems (QMS)

As the Manager, Quality Systems, you will support the design, implementation, an...

Location

Canada , Vancouver

Salary:

94880.00 - 118600.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

5+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Establishing, supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Serving as the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Managing QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Teams and social groups to build community and connections

Fulltime

Quality Assurance Manager - CLIA/CAP Laboratory

10x Genomics is establishing its first CLIA/CAP-certified laboratory to bring cu...

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 Life Sciences, Medical Laboratory Science, Quality Management, or related field
10+ years of experience in quality assurance within a regulated clinical laboratory (CLIA/CAP environment)
Demonstrated experience building or expanding quality systems in a CLIA lab setting
Strong working knowledge of CLIA / CAP quality and documentation requirements
Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 strongly preferred
Experience preparing for and leading CAP inspections and CLIA audits
Excellent written and verbal communication skills, with an ability to collaborate across scientific, operational, and regulatory functions
Hands-on, proactive, and adaptable, capable of working effectively in an early-stage, fast-growing diagnostic environment
Experience with LIMS, electronic QMS tools, and training management systems is required

Job Responsibility

Clinical Quality Framework Establishment and Oversight: Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations
Collaborate closely with CLIA and assay development teams to develop and manage SOPs and work instructions
Partner with the broader Quality/Regulatory team to integrate the CLIA lab’s quality infrastructure into 10x’s enterprise-wide quality management system (QMS)
Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing)
In partnership with CLIA Lab Director, ensure inspection readiness and execute regulatory submissions (CLIA, CAP, and state licensure)
Operational Quality Support: Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports
Serve as QA reviewer/approver for method validation, verification, and change control documentation for both laboratory methods and assay software components
Ensure effective management of reagents, instruments, and workflow changes per CLIA/CAP requirements
Support onboarding and verification of LDTs transferred from Diagnostic Assay Development teams
Act as quality liaison with external auditors and partners

What we offer

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

Fulltime

R&D Quality Laboratory Oversight (Associate Director)

Be a key quality leader ensuring high-quality, compliant analytical testing acro...

Location

Japan , Kanagawa

Salary:

Not provided

BioLife Plasma Services

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field
MS/PhD preferred
7+ years' experience in GxP laboratory quality oversight (GMP/GLP, analytical testing, inspections)
Strong knowledge of analytical methods and lab operations for small molecules and biologics
Proven skills in data integrity, deviation/CAPA management, and quality risk management
Clear communicator and collaborator, effective in a global matrix environment with competing priorities

Job Responsibility

Provide quality oversight for GxP and non-GxP labs across the R&D pipeline
Review and approve critical GMP/GLP documentation (methods, validations, deviations, CAPAs)
Ensure robust ALCOA+ data integrity controls in lab systems, processes, and records
Lead or support lab-related investigations, audits, and inspections with clear, timely CAPA
Collaborate with Pharmaceutical Sciences, Regulatory, Manufacturing, and QA to align on quality expectations

What we offer

Allowances: Commutation, Housing, Overtime Work
Salary Increase: Annually, Bonus Payment: Twice a year
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Fulltime

Quality Manager

Location

Spain , Segovia

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

University degree in Science or a related field
Agility learner, with experience in talent development (team of +15 people), as well as strong communication, impact, and influencing skills
Solution-oriented, with a strategic mindset and a strong focus on challenges and results
High level of English (B2/C1)

Job Responsibility

Lead the Quality and Laboratory team, ensuring that all products are manufactured in accordance with customer specifications and defined standards
Lead and continuously improve Quality and Sustainability Management Systems, ensuring compliance with standards such as ISO, IFS, BRC, PEFC, FSC, and OEKO-TEX®
Drive a culture of continuous improvement within the team and across the plant
Make decisions based on and analyze key indicators related to quality, customer satisfaction, and environmental impact
Identify, build, and develop the team, fostering a culture of growth and learning aligned with our values
Ensure compliance with BSCI (Business Social Compliance Initiative), promoting ethical and sustainable practices

Fulltime

Manager Quality Control (Micro and Sample Management)

Manager Quality Control (Micro and Sample Management) at Amgen Singapore Manufac...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Quality or Operations related experience
OR Bachelor's degree and 4 years of Quality or Operations related experience
OR Diploma and 8 years of directly related experience
Strong knowledge and understanding of microbiology testing methodology and strategy for contamination control
Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment
Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
Ability to lead diverse teams
Good communication skills (technical writing and verbal communication/presentation)
Ability to work in cross-functional and multisite teams

Job Responsibility

Lead and supervise QC Microbiology Shift teams
Maintain the weekly lab schedule and prioritize daily work tasks
Provide Quality oversight to ensure processes follow cGMP
Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP
Perform review, approval and tracking of cGMP processes, procedures, documents and records including nonconformance records and CAPAs
Oversee day to day activities in microbiology (routine environmental & utilities monitoring
raw material and product testing such as bioburden, microbial limits test, endotoxin, qPCR, microbial ID
media, reagent and culture qualification such as growth promotion
etc.)
Oversee sample management and stability (sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.)

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Engineering Technician III, Quality Manager

Responsible for the overall quality system and its implementation and management...

Location

Kuwait , Kuwait City

Salary:

Not provided

Amentum

Expiration Date

Until further notice

Requirements

An associate’s degree in engineering, engineering technology, physics or a related technical field from an accredited college or university, with at least ten (10) years of field experience. Includes qualification requirement OR Completion of a U.S. military precision measurement and calibration program, a precision measurement and calibration school at an accredited school, or within a specialized calibration firm, and have twelve (12) years of work experience in the calibration field with extensive experience in QA. Includes qualification requirement C
Demonstrated knowledge of the requirements of calibration laboratory compliance and accreditation to ISO 17025
Must have or be able to obtain and maintain a US Government Secret Security Clearance. NOTE: US Citizenship is required to obtain a Secret Clearance

Job Responsibility

Responsible for the overall quality system and its implementation and management for the KAF Metrology Program
Exercises independent judgment on issues concerning ISO 17025 and KAF related Quality documents
Performs trend analysis quarterly
Develops and maintains the laboratory quality manual and quality system using KAF command directives and standardized templates
Assessing requirements, developing and maintaining a complete QA Program for the KAFMB
Developing and maintaining a Quality Control program that ensures a high-quality product from all sections of the KAFMB
Coordinating with KAF management, QA, Laboratory Supervisors and Inspectors, Material/Production Control personnel and technicians to resolve problems and ensure an integrated effort
Develop, maintain, and implement a Quality Assurance Program as per ISO 17025 directives that ensures involvement of all management and technical levels in the implementation, updating and utilization of a quality-oriented program at the KAFMB labs
Developing a QA Program for laboratory facility and related environmental control, development, operation and maintenance
Assisting the Metrology Engineering Department in researching and developing a Primary Standards capability

Fulltime

Microbiology Product Testing Laboratory Manager - 14 Month FTC/Secondment

We are seeking an experienced and capable QC Release Laboratory Manager, Microbi...

Location

United Kingdom , Barnard Castle

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Higher National Certificate (HNC)/Higher National Diploma (HND) in a scientific or related discipline (e.g., Microbiology, Pharmacy, or other relevant science fields)
Experience in regulatory and technical knowledge of GMP requirements and GSK quality regulations
Experience in supervising teams or leading activities within GMP/GLP operations or quality functions
Experience to analyse complex information and makes decisions based on defined risk criteria, using structured communication and established mentoring process
Experience compiling technical information into structured documentation, present data and conclusions clearly to relevant stakeholders, and provide coaching using predefined materials and standardized processes
Experience planning, organising, and managing defined workloads, including the use of specified IT systems to meet operational timelines
Degree in a scientific or related discipline, such as Microbiology, Biomedical Sciences, Applied Biology, Quality Assurance, or other STEM fields, with experience working in regulated environments
Practical working knowledge of GPS principles, including PPM, problem solving, CI, and LSW and knowledge to improving GPS Maturity Scores

Job Responsibility

Oversee the performance of the QC Release Microbiology Team to deliver finished product testing and batch release requirements
Ensure robust, validated, and compliant microbiological methodologies in line with regulatory and company quality standards
Drive continuous improvement, deviations, root cause analysis, process improvements within the team
Train and develop team members, creating structured development plans along with stretch objectives, and fostering a safe and efficient working environment
Support microbiology testing-related project activities, ensuring adherence to schedule, including New Product Introduction (NPI) requirements
Lead preparation activity and represent the department during external regulatory inspections and company internal audits
Provide technical leadership, supervise lab investigations, and address GMP microbiological issues in collaboration with production and quality teams
Drive resource planning, monitor team workload, compliance metrics and training status
Prioritisation to meet workload demands effectively
Support the QC improvement plan aligned to the 6 QC KPIs

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Band 7 Haem/Transfusion Quality Manager

Location

United Kingdom , London

Salary:

Not provided

Hunter Gatherer AHP

Expiration Date

Until further notice

Requirements

Must have previous Haematology quality management experience
Strong experience dealing with UKAS accreditation processes
Experience using QPulse is essential
Strong governance, quality systems and documentation experience
Biomedical Scientist background desirable

Job Responsibility

Preparing for UKAS inspections / accreditation
Document review and control
Governance activities
Producing quality reports
Data analysis / data crunching
Supporting and maintaining laboratory quality systems

What we offer

Quick & simple registration process
Market-leading pay rates
One dedicated recruitment consultant throughout your placement
Access to exclusive locum opportunities nationwide
Prompt weekly payroll
Refer a friend and earn £250 when we successfully place them in a role

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Quality Systems & Laboratory Manager

Job Description

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