Job summary
An excellent opportunity has presented itself at Great Ormond Street Hospital Trust, Zayed Centre for Research into Rare Disease (ZCR) for a Quality Assurance (QA) Manager in our Cell and Gene Therapy Service. We are proud of being part of a well renowned national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK.
The Cell and Gene Therapy Service manufactures life-saving therapies for paediatric patients under our MHRA licences. We are expecting to soon manufacture within our new state of the art, purpose-built facility (ZCR), comprising of seven GMP compliant laboratories and support services. Our manufacturing facilities are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and MS licences.
The QA Manager will manage, monitor, and oversee the Quality Management System and Document Management System within the Cell and Gene Therapy Service. They will be responsible for maintaining adherence to GMP principles and regulatory requirements. This includes leading the implementation and improvement of QMS as well as ensuring GMP documentation, quality records, qualification and validation documents are reviewed and approved in a timely manner.
Main duties of the job
The QA Manager will also oversee the training programme, participate in audits and inspections, and manage the QA team. In addition, the postholder will support supplier qualification and document archiving activities.
We are therefore looking for a highly motivated individual who has a strong understanding of QA, GMP principles, and regulatory requirements. They will possess excellent communication, organisational, and leadership skills. The QA Manager will collaborate with various stakeholders, including the Head of Quality, QA Technical Lead, QC Manager, Head of Product Manufacturing, Production Manager, and Laboratory Manager and Validation Lead as well as external partners. This role is crucial in maintaining a culture of quality and excellence within the department, and the manager will play a pivotal role in ensuring that all Quality activities meet the highest standards of compliance and efficiency.
This is a fantastic opportunity to join our friendly and welcoming Quality team with its great diversity of skills and experience, we look forward to receiving your application.
For further information, please contact:
Shok Ping Lim (shokping.lim@gosh.nhs.uk)
About us
GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination. We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members. We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women's staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust's mission, values and efforts specific to inclusion. All of our staff networks are open to any employee
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required. For both documents please view the attachment/s below.
Person Specification
GOSH Culture and Values
Essential
Academic/Professional qualification/Training
Essential
- BSc or equivalent in relevant scientific discipline
- Postgraduate qualification in Pharmaceutical Quality Assurance or equivalent experience
- Training in QMS, QA or relevant experience
Experience/Knowledge
Essential
- Thorough understanding of Good Manufacturing Practice and Good Clinical Practice
- Thorough understanding of regulatory requirements pertaining to ATMPs and sterile products
- Proven experience in line managing staff
- Proven experience of training and supervising
- Experience of working in a licensed facility holding an MIA(IMP)
- Proven experience of working in a QA environment
- Proven experience of QMS management and monitoring
- Proven experience of Document Control System management
- Proven experience of change, deviation, risk and CAPA management
- Proven experience of leading of deviation investigation and root cause analysis
- Proven experience of supplier assessment and approval
- Proven experience in qualification and validation activities
- Proven experience of training programme management in a GMP facility
- IT competent (Word, Excel and Power Point)
Desirable
- Experience of working under a Specials licence
- Experience of using Q-Pulse
Skills/Abilities
Essential
- Ability to work on assigned projects with limited supervision
- Strong communication skills, both verbal and written
- Good attention to detail and accuracy
- Strong organisational skills and demonstrated ability to prioritise and meet deadlines
- Strong leadership skills
- Ability to work independently and as part of a team
- Demonstrated critical thinking and good problem-solving skills
- Demonstrated ability to teach and supervise
- Good personnel management skills
- Strong computer and scientific skills
- Demonstrated ability to self-motivate and a positive attitude
Desirable
Person Specification
GOSH Culture and Values
Essential
Academic/Professional qualification/Training
Essential
- BSc or equivalent in relevant scientific discipline
- Postgraduate qualification in Pharmaceutical Quality Assurance or equivalent experience
- Training in QMS, QA or relevant experience
Experience/Knowledge
Essential
- Thorough understanding of Good Manufacturing Practice and Good Clinical Practice
- Thorough understanding of regulatory requirements pertaining to ATMPs and sterile products
- Proven experience in line managing staff
- Proven experience of training and supervising
- Experience of working in a licensed facility holding an MIA(IMP)
- Proven experience of working in a QA environment
- Proven experience of QMS management and monitoring
- Proven experience of Document Control System management
- Proven experience of change, deviation, risk and CAPA management
- Proven experience of leading of deviation investigation and root cause analysis
- Proven experience of supplier assessment and approval
- Proven experience in qualification and validation activities
- Proven experience of training programme management in a GMP facility
- IT competent (Word, Excel and Power Point)
Desirable
- Experience of working under a Specials licence
- Experience of using Q-Pulse
Skills/Abilities
Essential
- Ability to work on assigned projects with limited supervision
- Strong communication skills, both verbal and written
- Good attention to detail and accuracy
- Strong organisational skills and demonstrated ability to prioritise and meet deadlines
- Strong leadership skills
- Ability to work independently and as part of a team
- Demonstrated critical thinking and good problem-solving skills
- Demonstrated ability to teach and supervise
- Good personnel management skills
- Strong computer and scientific skills
- Demonstrated ability to self-motivate and a positive attitude
Desirable
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Great Ormond Street Children's Hospital
Great Ormond Street
London
WC1N 3JH
Employer's website
https://www.gosh.nhs.uk/ (Opens in a new tab)
