Development Quality Assurer Job at 360 Resourcing Solutions (Basingstoke)

Supplier Quality Development Manager

The Supplier Quality Development Manager (SQDM) develops, implements, leads and ...

Location

United States , Seneca

Salary:

125600.00 - 172700.00 USD / Year

BorgWarner

Expiration Date

Until further notice

Requirements

Bachelor's degree in engineering or technical field (e.g. Mechanical, Industrial, Production technology) with solid technical background
7+ years of professional experience in Quality, Production, Logistics, Cost/Process Planning
Strong communication skills, team player, comprehensive thinking, management skills and highly flexible
Commodity experience required
7+ years Supply Management experience working in Automotive Production environment preferred
Increasing responsibility in an automotive production environment
Proven record in Manufacturing, Supplier Quality and Process Improvement initiatives
Demonstrated competence in negotiating skills and assessing vendors
Fluency in English and Foreign Language preferred
Excellent Quality Orientation

Job Responsibility

Create, execute, communicate and maintain supplier quality strategy for commodities
Manage a team of direct reports to facilitate execution of supplier quality goals and objectives
Coordinates the Supplier Quality Managment Engineers (SQME) activities for New Product Development and/or changes related to current products
Create and implement Supplier Vetting Strategy, Supplier Capability Assessment, Supplier Selection (Pre-Sourcing) and Development Strategy, and Key Supplier Performance Metrics
In collaboration with Global Supply Management Manager and Quality Director, develop and implement supplier quality roadmap
Create and implement global commodity quality requirements
Benchmark suppliers on Best in Commodity production strategies
Identify new technologies that support BorgWarner's growth and product leadership position in the market
Identify and develop Suppliers that meet and/or exceed BorgWarner long-term expectations that result in a differentiation in the marketplace
Create supplier quality vetting strategies

Fulltime

Executive Director, Research & Development Quality Assurance

Joining Moderna offers the unique opportunity to be part of a pioneering team th...

Location

United States , Cambridge; Bethesda

Salary:

224900.00 - 404600.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Bachelor's degree in a life science or related field
advanced degree preferred
15+ years of progressive experience in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials, regulatory submissions, laboratories and PV and clinical safety
10+ years' experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals
Expertise to oversee comprehensive resource and staffing management, building high-performing teams and fostering a culture of continuous improvement and accountability
Experience in the development and execution of robust audit schedules, coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration
Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines, including ICH E2 and EU PV legislation
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH regulations, guidance and local legislation for clinical trials, including a ICH E6 (R3)
Proven ability to collaborate and influence in a fast-paced, matrixed environment

Job Responsibility

Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna's entire development portfolio
Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna's innovation agenda
Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas
Embed risk-based quality management principles into study design, data generation, and vendor oversight practices
Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA, EMA, MHRA), ensuring timely and effective resolution of findings
Drive modernization of vendor oversight and shared accountability models, elevating external partnership performance
Build and lead a high-performing, solutions-oriented R&D QA team, rooted in scientific credibility and operational excellence
Enhance Quality Culture across R&D by promoting real-time quality management, early issue detection, and continuous feedback loops
Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance
Own the end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs
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

Freelance External Quality Assurer

You will be conducting External Quality Assurance activities in accordance with ...

Location

United Kingdom , Nationwide

Salary:

Not provided

Central YMCA

Expiration Date

Until further notice

Requirements

Hold qualifications in the fitness and active leisure sector
PGCE or Certificate in Education
DTTLS qualification or equivalent
V1 qualification or equivalent
A1 qualification or equivalent
L4 external quality assurance qualification (desirable)
Excellent communication skills
Great rapport building ability
Ability to manage conflict and provide constructive feedback
Highly organised

Job Responsibility

Conduct External Quality Assurance activities in accordance with YMCA Awards EQA strategy for YMCA Awards units, qualifications, accredited and endorsed programmes
Contribute and support with the development of units, qualifications and resources
Maintain appropriate and professional communication with the Lead Quality Assurer and other REQA team members to ensure a standardised approach
Regularly maintain effective quality assurance and audit systems
Make accurate decisions based on relevant evidence provided by approved centres, applying sanctions where appropriate
Provide technical guidance and support to customers and the wider YMCA Awards team
Attend regular meetings as required for standardisation purposes
Complete all related external quality assurance documentation in line with the YMCA Awards procedures and regulatory requirements

Freelance External Quality Assurer

Freelance role conducting external quality assurance for YMCA Awards, requiring ...

Location

United Kingdom , Nationwide

Salary:

Not provided

Central YMCA

Expiration Date

Until further notice

Requirements

Hold qualifications in the fitness and active leisure sector
Proficiency in the medium of Welsh
PGCE or Certificate in Education
DTTLS qualification or equivalent
V1 qualification or equivalent
A1 qualification or equivalent
L4 external quality assurance qualification (desirable)
Excellent communication skills
Great rapport building ability
Ability to manage conflict and provide constructive feedback

Job Responsibility

Conduct External Quality Assurance activities in accordance with YMCA Awards EQA strategy for YMCA Awards units, qualifications, accredited and endorsed programmes
Contribute and support with the development of units, qualifications and resources
Maintain appropriate and professional communication with the Lead Quality Assurer and other REQA team members to ensure a standardised approach
Regularly maintain effective quality assurance and audit systems
Make accurate decisions based on relevant evidence provided by approved centres, applying sanctions where appropriate
Provide technical guidance and support to customers and the wider YMCA Awards team
Attend regular meetings as required for standardisation purposes
Complete all related external quality assurance documentation in line with the YMCA Awards procedures and regulatory requirements

Parttime

Senior Scientist, Analytical Development and Quality Control

The Senior Scientist, Analytical Development and Quality Control will support an...

Location

United States , Waltham

Salary:

115000.00 - 140000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

PhD with a minimum of 6 years, MS with a minimum of 10 years, or BS with a minimum of 12 years of experience in analytical development and quality control within the pharmaceutical or biotech industry
Proven experience with peptides and small molecules in both injectable and solid oral dosage forms
Experience managing outsourced activities with CDMOs
Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, and spectroscopic methods
Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development
Proven effective communication and interpersonal skills
Ability to work effectively in a fast-paced, collaborative environment

Job Responsibility

Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs)
Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards
Perform detailed review and provide data integrity oversight of data generated at CDMOs
Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes
Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements
Oversee stability programs to support product retest, shelf-life, and expiration dating
Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs)
Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data
Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations
Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.)

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Quality Assurance-Learning & Development Intern

Simtra BioPharma Solutions is offering a Summer Internship opportunity in Qualit...

Location

United States , Bloomington, Indiana

Salary:

15.00 - 25.00 USD / Hour

EdTech Jobs

Expiration Date

Until further notice

Requirements

Pursuing a BS or MS degree in Life Sciences, IT/Information Systems, Quality Assurance, Instructional Design, or a related field
Strong oral and written communication skills – including visual design skills
Ability to work with technical documentation and translate user needs into clear, structured evaluation/assessment tools
Comfortable learning new systems and navigating digital platforms
High attention to detail with strong organizational skills
Comfortable working in a fast-paced regulated manufacturing environment
Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) with ability and willingness to learn new tools
Experience with Learning Management System platforms (i.e., SuccessFactors, ComplianceWire, Veeva, etc.)
Interest in digital transformation or paperless workflows
Exposure to instructional design, training development, system mapping, or process improvement

Job Responsibility

Leverage a new digital evaluation and assessment checklist feature in the LMS, ensuring it is configured and used properly across relevant training programs
Upload and map existing qualifications and training materials into the LMS, ensuring accuracy, version controls, and alignment with QA requirements
Work with training owners, SMEs (subject matter experts), and QA reviewers to identify which qualifications need migration into the new digital format
Author, revise, and update electronic evaluation and assessment checklists
Support the transition to a paperless training system, including digitizing documentation, improving workflows, and identifying process efficiencies
Assist with testing, validating, and troubleshooting digital training tools as they are rolled out

What we offer

Gain hands-on experience
Contribute to improving training systems
Work closely with industry professionals
Learn to problem solve on real-world projects
Learning sessions with top leadership
Site visits to local projects
Social events

Fulltime

Quality Matters Advisor - Learning & Development

We are looking for an individual who has a passion for Learning & Development, w...

Location

United Kingdom , Leicester

Salary:

30592.00 - 31816.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Passion for Learning & Development
Committed to ensuring up to date with own training needs and requirements
Full, clean driver’s licence
Own vehicle

Job Responsibility

Provide support to the Quality Matters Manager and Workforce Development Director to review learning and development needs within our services to ensure on-going training targets are met
Provide support and guidance to Care Home Managers in the implementation of learning & development plans/systems, with ongoing review to demonstrate continuous improvement measured through the Prime Life Risk Matrix
Provide, support and guidance to Managers, Regional Teams and employees
Provide direct staff training through face to face, eLearning, competency checks, supervision and distance learning methods
Maintain accurate and relevant documentation and reports to reflect practice and planned development

What we offer

Attractive remuneration package
Training and support required

Fulltime

New

Audit Quality Specialist

Membership Bespoke is delighted to be supporting a globally recognised membershi...

Location

United Kingdom , Ashford

Salary:

55000.00 GBP / Year

Membership Bespoke

Expiration Date

Until further notice

Requirements

Recognised Internal Auditor qualification
Recognised Lead Auditor qualification
Experience working within quality assurance, certification, accreditation, compliance or audit environments
Strong knowledge of audit methodologies and quality management systems
Excellent communication and stakeholder management skills
Experience of ISO-based standards and audit frameworks
Experience in external, certification, accreditation or supplier auditing
Audit quality assurance and report review
Managing, mentoring or developing auditors
Auditor calibration and competence assessment

Job Responsibility

Drive consistency, quality and continual improvement across the audit programme
Review audit reports and provide constructive feedback to auditors
Monitor auditor performance and identify opportunities for development and improvement
Support auditor calibration and promote consistent interpretation of standards and audit findings
Conduct internal audits and support risk-based audit planning activities
Analyse audit data and trends to identify risks, opportunities and areas for improvement
Produce management reports and quality metrics
Develop and enhance audit procedures, guidance and best practice documentation
Support auditor recruitment, onboarding and ongoing competence development
Ensure compliance with relevant quality, governance and certification standards

What we offer

Free parking

Fulltime

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