Quality assurance managers Work, Jobs in Bledington, Oxf (with Salaries)

Quality Assurance Officer II
Replimune —Abingdon
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Quick apply
3d
Quality Assurance Officer I
Replimune —Abingdon
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Quick apply
2d
Quality Assurance Technical Officer
University of Oxford —Oxford
- £39,424 - £51,983 a year
- Full-time
- Laboratory experience
1d
Senior Product Assurance Manager
Astroscale —Didcot
- £60,000 - £94,000 a year
- Full-time
- Hybrid work
- English
- Presentation skills
- Travel
- Life insurance
- Sick pay
Quality Assurance Regulatory Affairs Coordinator
Perspectum —Oxford
- £30,000 - £40,000 a year
- Full-time
- Microsoft Office
- IT
Quick apply
Quality Manager
BAMD ltd —Upper Heyford
- £32,022.84 - £63,570.64 a year
- Full-time
- Analysis skills
- Bachelor's degree
- Continuous improvement
- Referral programme
Quick apply
Quality Systems Coordinator
Oxford Nanopore Technologies —Oxford
- Full-time
- Administrative experience
- Continuous improvement
- Communication skills
Head of Quality
Infinitesima —Abingdon
- £65,000 - £85,000 a year
- Hybrid work
- Leadership
- Annual leave
Quick apply
Electrical Quality Systems Team Leader
UK Atomic Energy Authority —Culham
- £57,117 a year
- Full-time
- Remote
- Management
- Engineering
- Travel
- Annual leave
- Employee assistance programme
Quick apply
10d
Project Quality Engineer
Tokamak Energy —Abingdon
- £50,000 - £65,000 a year
- Full-time
- Mechanical knowledge
Quick apply
Technical Manager
Absolute Taste —Bicester
- Up to £55,000 a year
- Full-time
- Mentoring
- Communication skills
Quick apply
1d
Quality Specialist
LGC Diagnostics & Genomics —Kidlington
- Weekend availability
- Remote
- Bachelor's degree
- Travel
Quick apply
10d
Quality Engineer
Prodrive —Banbury
- Full-time
- Analysis skills
- Travel
- Employee discount
Quick apply
QA Operations Manager
Evotec —Abingdon
- Full-time
- Management
- Bachelor's degree
- Continuous improvement
6d
Management Systems & Audit Manager
Northrop Grumman —Cheltenham
- Hybrid work
- Analysis skills
- Travel
- Organisational skills
- Employee assistance programme
10d
Quality Engineer (Medical Devices)
Amber Therapeutics —Didcot
- Full-time
- Hybrid work
- Engineering
- Quality control
- Communication skills
Quick apply
14d
Product Quality Engineer
OrganOx —Oxford
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Outlook
Quick apply
1d
Food Hygiene Manager
OCS Group —Evesham
- Overtime
- Microsoft Office
- Continuous improvement
- Computer skills
Quick apply
Technical Coordinator
The Menu Partners —Bicester
- Up to £33,000 a year
- Full-time
- Microsoft Office
- Organisational skills
- Communication skills
- Employee assistance programme
Quick apply
1d
Regional Supplier Quality Engineering Manager
Moog Inc. —Tewkesbury
- Full-time
- PMP
- Engineering
- Data analysis skills
- Free parking
- Annual leave

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Quality Assurance Officer II

Replimune -
Abingdon

Quick apply

Job details

Full-time
3 days ago

Qualifications

Microsoft Office
Master's degree
Bachelor's degree
IT
Root cause analysis
Communication skills
FDA regulations
Time management

Full job description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

The Quality Assurance Officer II provides guidance and coordination in the development, implementation and maintenance of Quality Assurance systems and activities at Replimune. Manages batch review to ensure timely release of drug product for clinical and commercial use. Ensures relevant quality and regulatory requirements are met for manufacturing and testing and ensures site compliance with quality system regulations issued by MHRA, EMA, FDA and other applicable regulatory bodies. Responsible for the evaluation and assurance that appropriate quality systems are in place at approved vendors and suppliers supporting GXP.

This position is based in our Milton Park location and typically has a 5-day on-site expectation.

Key responsibilities:

Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness. Provide QA input and approvals to assist in and drive projects as needed.
Perform batch review for GMP lots, in support of Qualified Person release including final Quality Review of associated quality records. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
Possess strong writing skills to utilize best practices in documenting deviations in records and associated reports.
Collect and report quality metrics supporting Quality Management Review (QMR) deliverables.
Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, GMP records, Testing Records and other records generated by the site ensuring internal and external standards are met.
Interface and provide support to internal customers.
Lead and participate in Risk assessments.
Conduct trainings as needed (change control, batch release, risk assessment methodology, etc.).
Conduct routine compliance oversight activities e.g. facility/laboratory walkarounds.
Take part in Replimune internal and external audit program. Lead and direct audits of GMP materials and service providers.
Interface with internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.
Ability to prepare slides and provide training to staff in applicable procedures.
Prepare and issue controlled logbooks for internal customers.
Archive and retrieval of documentation.

Other responsibilities

Support Replimune Clinical QA activities.
Drafts, reviews, provides oversight to content, and approves controlled documents which may include but are not limited to standard operating procedures, validation documents, material specifications, etc.
Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to support Replimune Clinical and Commercial operations.
Other duties as assigned.

Educational requirements:

A minimum of a bachelor’s degree (BSc or equivalent).
Masters preferred.

Experience and skill requirement:

6 years’ experience in relevant Quality Systems, technology and/or supervision in a regulated biotechnology or pharmaceutical industry environment.
GxP experience, including auditing.
Knowledge of MHRA, EMA and FDA guidelines regarding GMPs.
Excellent verbal and written communication skills to interact with other functions.
High level of attention to details and excellent time management.
IT skills – competent in using Microsoft Office.
An interest in pharmaceutical Quality Assurance.
A level of flexibility is essential to meet varying workloads.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.

Quick apply

Refine Your Search

quality assurance managers jobs in bledington, oxf

Quality Assurance Officer II

Quality Assurance Officer I

Quality Assurance Technical Officer

Senior Product Assurance Manager

Quality Assurance Regulatory Affairs Coordinator

Quality Manager

Quality Systems Coordinator

Head of Quality

Electrical Quality Systems Team Leader

Project Quality Engineer

Technical Manager

Quality Specialist

Quality Engineer

QA Operations Manager

Management Systems & Audit Manager

Quality Engineer (Medical Devices)

Product Quality Engineer

Food Hygiene Manager

Technical Coordinator

Regional Supplier Quality Engineering Manager

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