Director of risk management Work, Jobs in Lambeth, Gtl (with Salaries)

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT
Vertex Pharmaceuticals —Paddington
- Full-time
- Master's degree
- Bachelor's degree
- Travel
Director, Technology, Cyber & Resilience Risk
London Stock Exchange Group —London
- Full-time
- Computer Science
- Engineering
- No degree
Associate Director of Estates and Facilities
Brunel University —London
- Up to £87,715 a year
- Full-time
- Hybrid work
- Maintenance
- University
- Continuous improvement
- Annual leave
Senior Director - Executive Compensation and Equity Program
Boston Consulting Group —London
- £195,000 - £227,500 a year
- Full-time
- Leadership
- Profit sharing
- Annual leave
Programme Director [Transformation]
Network Rail —London
- £116,753 - £150,696 a year
- Full-time
- Project management
- No degree
- Leadership
- Annual leave
- Employee discount
13d
Director of Communications & Engagement
Home Office —London
- £120,000 - £150,000 a year
- Full-time
- Presentation skills
- Leadership
Project Management, PSG Senior Manager - 12-Month Contract
Boston Consulting Group —London
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Project management
Head of Change
Guy's & St Thomas' Foundation —London
- £73,000 - £78,000 a year
- Hybrid work
- PMP
- Analysis skills
- Leadership
- Annual leave
- Employee assistance programme
Quick apply
Senior Director, Global Controls and Obligations Management
Airwallex —London
- £220,000 - £320,000 a year
- Full-time
- Hybrid work
- Analysis skills
- Communication skills
- Banking
PMO Manager
Imperial College London —South Kensington
- £57,785 - £69,365 a year
- Full-time
- Analysis skills
- Organisational skills
- Agile
- Annual leave
Head of Technical Governance & Assurance
Sodexo —London
- £80,000 a year
- Full-time
- Engineering
- Maintenance
- University
- Gym membership
Quick apply
10d
Part time Head of Risk / Compliance
Baldwin Doherty Partners —London
- £70,000 - £150,000 a year
- Part-time
- Bachelor's degree
- In-person
Quick apply
7d
Senior Director, Program Management & Strategic Initiatives
Clarivate —London
- Full-time
- Master's degree
- Business
Chief of Staff £75,585 - £84,840 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency —London
- £75,585 - £84,840 a year
- Full-time
- Master's degree
- Administrative experience
- Project management
- Annual leave
- Sick pay
12d
Director of Procurement
NextStep —London
- £140,000 - £170,000 a year
- Full-time
- Hybrid work
- Leadership
Quick apply
PMO Manager
NextStep —London
- £80,000 - £100,000 a year
- Full-time
- Hybrid work
- PMP
- Analysis skills
Quick apply
Director of Security Operations
Wave —London
- Up to £190,900 a year
- Remote
- Childcare
- Up to 50% travel
- English
Head of Corporate Facilities Management Operations
Southwark Council —London
- Full-time
- Contracts
11d
Senior Director of Service Delivery
WTW —Reigate
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Continuous improvement
- Annual leave
- Employee assistance programme
5d
Head of Knowledge Management
International SOS —London
- Computer Science
- Master's degree
- Bachelor's degree

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director of risk management jobs near lambeth, gtl

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

Vertex Pharmaceuticals -
Paddington

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Job details

Full-time

Qualifications

Master's degree
Six Sigma
Bachelor's degree
Root cause analysis
Communication skills

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

director of risk management jobs in lambeth, gtl

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

Director, Technology, Cyber & Resilience Risk

Associate Director of Estates and Facilities

Senior Director - Executive Compensation and Equity Program

Programme Director [Transformation]

Director of Communications & Engagement

Project Management, PSG Senior Manager - 12-Month Contract

Head of Change

Senior Director, Global Controls and Obligations Management

PMO Manager

Head of Technical Governance & Assurance

Part time Head of Risk / Compliance

Senior Director, Program Management & Strategic Initiatives

Chief of Staff £75,585 - £84,840 p.a. + benefits

Director of Procurement

PMO Manager

Director of Security Operations

Head of Corporate Facilities Management Operations

Senior Director of Service Delivery

Head of Knowledge Management

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