Development director Work, Jobs in Ascot, Brk (with Salaries)

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT
Vertex Pharmaceuticals —Paddington
- Full-time
- Master's degree
- Bachelor's degree
- Continuous improvement
Charter Manager (Private Jet and Helicopter Charter)
Starflight Aviation LTD —Farnborough
- £50,000 - £60,000 a year
- Weekend availability
- CRM software
- Customer service
- Business development
- Free parking
Quick apply
Project and Assistant Event Manager
Sodexo —Ascot
- Continuous improvement
- Communication skills
- Employee discount
Quick apply
6d
Executive Director for Place
Wokingham Borough Council —Wokingham
- £148,609 a year
- Full-time
- Annual leave
- Employee assistance programme
5d
Senior Neurodevelopmental Assessor
Skylight Psychiatry —Basingstoke
- £60,000 - £65,000 a year
- Hybrid work
- Computer literacy
- Travel
- Data entry
- Annual leave
Project Coordinator
Impact Food Group —Woking
- Full-time
- Databases
- Communication skills
- School
- Annual leave
- Employee discount
Quick apply
Part-time HR Manager (Learning & Development/ Organisational Development)
Reading Students' Union —Reading
- £26,139.74 a year
- Hybrid work
- Project management
- University
- Human resources
- Annual leave
Quick apply
Events & Digital Marketing Coordinator
Oakley Food Projects —Wokingham
- £22,450 - £25,650 a year
- Part-time
- Social media management
- Organisational skills
- In-person
- Free parking
- Profit sharing
Quick apply
Sr Director, Drug Development Lead
IQVIA —Reading
- Full-time
- Remote
- Management
- Doctoral degree
- Master's degree
- Work from home
8d
Deputy Chief People Officer
Hampshire Hospitals NHS Foundation Trust —Basingstoke
- £112,782 - £129,783 a year
- Full-time
- Continuous improvement
- Recruiting
- Contracts
Director of People & Culture
Norwood —London
- £95,000 - £100,000 a year
- Human resources
- Mentoring
- Recruiting
- Free parking
- Annual leave
Quick apply
11d
Director, Portfolio Development Process & Standards Lead
CSL Behring —Maidenhead
- £230,000 - £270,000 a year
- Full-time
- Hybrid work
- Nursing
- Master's degree
- Bachelor's degree
Regional HR Business Partner - South
The Club Company —Twyford
- £0 a year
- Full-time
- Hybrid work
- Hotel
- Continuous improvement
- Human resources
- Employee assistance programme
Leadership Team PA - Maritime and Land
QinetiQ —Farnborough
- £38,475 - £42,750 a year
- Full-time
- Microsoft Office
- Organisational skills
- Communication skills
- Employee discount
20h
Storytelling Director
Larian Studios —Guildford
- Full-time
- Team management
- Mentoring
Study Engagement and Advice Manager
Buckinghamshire New University —High Wycombe
- £38,784 - £43,482 a year
- Weekend availability
- Hybrid work
- Continuous improvement
- Team management
- Travel
- Employee discount
5d
Regional HR Business Partner - North
The Club Company —Twyford
- £0 a year
- Full-time
- Hybrid work
- Continuous improvement
- Human resources
- Resort
- Employee assistance programme
Senior Director/Director EMEA HR Business Partner/Leader - Qualcomm, UK or Germany
Qualcomm —Farnborough
- Doctoral degree
- Master's degree
- Bachelor's degree
Director of Operations
Jobs In. Fitness —London
- Up to £80,000 a year
- Hospitality
- Continuous improvement
- Team management
Quick apply
7d
Senior HR Business Partner
Explore! —Farnborough
- £60,000 - £65,000 a year
- Presentation skills
- Human resources
- Recruiting
- Free parking
- Flexible schedule
5d

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development director jobs near ascot, brk

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Vertex Pharmaceuticals -
Paddington

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Job details

Full-time

Qualifications

Stakeholder collaboration
Quality management change control procedures
Stakeholder liaison
Master's degree
Six Sigma
Quality assurance
Bachelor's degree
Continuous improvement
Continuous improvement cycles oversight
Partnership building
Risk management
Quality management system (QMS) implementation
Communication skills
Internal quality assurance
Corporate regulatory compliance oversight

Full job description

Job Description

General/Position Summary

The Director , Quality Assurance GMP Operations is responsible for the applicable Cell & Gene CDMO and is responsible for the end to end quality oversight of all product and activities at the CDMO. Responsibilities include day-to day operational quality oversight including assuring progression of batch record operations , resolution and on time disposition of product, quality continuous improvements, changes associated with the process and associated implementation, trends, and overall quality performance of the CDMOs .

The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities and participat ion in governance committees . A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities . The role may also be required to support on site manufacturing activities at the CDMO .

Key Duties & Responsibilities

Establishment of quality oversight for external C T O/C D MO operations including assurance of on time of batch disposition process , across development, launch and commercial manufacturing globally.

Lead, Develop, and implement continuous quality improvements to a dvanc e quality outcomes and operational excellence in processes.

Proactively develop Compliance metrics as key indicators and takes action to mitigate .

Maintain full oversight of CDMO QMS including driving deviation reduction a nd assuring timely resolution of CAPAs.

Act as the SME for the CDMO , understanding scope of all changes, driving applicable global change control implementation with the external manufacturing partner to meet global product goals.

Represent Quality and serve as a trusted partner for the disposition activities of drug product.

Build strategic relationships and foster a culture of collaboration with internal and external partners – CDMOs and CTOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary.

L ead/support the development of quality & technical risk mitigation through identification and mitigation compliance gaps .

Lead and mentor other team members, support development of organizational capabilities and talent building.

Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits.

Establish /parti ci pate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.

Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.

Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.

May be required to support manufacturing on site activities.

Required Education Level

Batchelor 's degree or relevant comparable background.

Masters preferred.

Required Experience

10 + years of experience and 5 + years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs ).

Broad and c urrent knowledge of batch disposition industry trends and best practices in Cell/Gene therapies.

Preferred QA Operational experience for Autologous Cell Therapy Operations.

Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.

Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. P roven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.

Ability to apply risk management principles to decision making and operational priorities.

Critical Thinking and Problem Solving skills

Ability to closely collaborate and build relationships with internal and external stakeholders .

Other Requirements
Indicate required certifications, licenses or specialized trainings.

Up to 25 % Travel may be required

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

Refine Your Search

development director jobs in ascot, brk

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Charter Manager (Private Jet and Helicopter Charter)

Project and Assistant Event Manager

Executive Director for Place

Senior Neurodevelopmental Assessor

Project Coordinator

Part-time HR Manager (Learning & Development/ Organisational Development)

Events & Digital Marketing Coordinator

Sr Director, Drug Development Lead

Deputy Chief People Officer

Director of People & Culture

Director, Portfolio Development Process & Standards Lead

Regional HR Business Partner - South

Leadership Team PA - Maritime and Land

Storytelling Director

Study Engagement and Advice Manager

Regional HR Business Partner - North

Senior Director/Director EMEA HR Business Partner/Leader - Qualcomm, UK or Germany

Director of Operations

Senior HR Business Partner

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