Quality Manager (GCP)
- Recruiter
- Vaccitech (UK) Limited
- Location
- Oxfordshire
- Salary
- Competitive
- Posted
- 17 Jul 2022
- Closes
- 13 Aug 2022
- Sectors
- Travel & Tourism
- Contract Type
- Permanent
- Hours
- Full Time
The Company
Vaccitech plc is a fast-growing biotech company. At only five years old we already have a development portfolio of six products, a partnered product that is in commercial production that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We run clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.
In December 2021 Vaccitech acquired Avidea Technologies with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us US operational presence in Maryland, complements Vaccitech s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. From March 2022 Vaccitech's UK headquarters will be moving to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.
The role
The role will work closely with the Director of Quality and Vaccitech staff to advise and oversee GCP and GMP compliance in the Clinical, Laboratory and Manufacturing group in accordance with local and international quality requirements. The role will include review and approval of key quality documents, including SOPs, Policies, Forms, batch documentation, validation / qualification documentation and Quality Agreements.
Key areas of responsibility will include, but are not limited to:
Supporting the Director of Quality in the management of the Vaccitech Quality Management System (QMS) to include SOPs, Deviations, CAPA, Change Control, Audits, risk management;
Ensuring good practices (GxP) are communicated, adopted and implemented throughout the organisation by maintaining current knowledge of local and international regulations;
Providing Quality expertise and oversight internally to project teams and other departments;
Working with the Director of Quality to ensure Vaccitech maintains Inspection Ready Status at all times;
Acting in the capacity of Quality Representative for all tasks defined in the quality system documents;
Establishing Key Performance Indicators (KPI) and producing regular Quality Reports for Management;Delivering Quality training to staff to include induction and refresher training for GCP and GMP
Auditing
Supporting the risk-based annual External/Contract Service Provider (CSP) audit programme and maintaining the Approved Supplier List;
Supporting the risk-based internal audit programme by creation of an annual internal audit schedule;
Managing the study specific audit programme;
Performing internal, CSP, clinical site, CDMO and study specific audits;
Key Document audits, e.g., validation reports, regulatory submissions, clinical essential documents, Clinical Study Reports, etc.;
In addition you will be:
Supporting and deputising for the Director of Quality (i.e., delegate);
Supporting the Director of Quality to ensure that the company s statutory and legal obligations are discharged to satisfy current legislation relating to Quality/GxP;
Ensuring compliance with GCP, GMP and other regulatory requirements;
Line management responsibilities and supporting the development for junior QA staff
Qualifications and/or experience required to perform the role
Minimum of four years quality assurance experience in a pharmaceutical or Biotechnology organisation;
At least three years experience as a Clinical Quality Assurance Auditor;
Degree in a scientific subject (preferably a Biological Science);
Good communication and interpersonal skills with the ability to communicate effectively with staff / and sub-contractors at all levels and different cultures;
Good experience of conducting internal and external audits (on site and remotely);
Detailed knowledge of GCP is mandatory;
Detailed knowledge of MHRA (essential), EMA and FDA standards (desirable)
Knowledge of GCP for laboratories is desirable;
Good knowledge of GMP (with reference to Annex 13 - Investigational Medicinal Products);
Experience in delivering training to staff on Quality topics;
Experience in working with or implementation of an electronic QMS is desirable;
A good working knowledge of MS Office including Word, Excel, Outlook and PowerPoint;
A flexible "can do" attitude;
Ability to work independently;
Pragmatic and adaptable;
Line management experience desirable;
Willingness to undertake some travel as part of auditing or to visit Vaccitech North America Inc. site;
What We Can Offer
Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer flexible forms of hybrid working (3 days in the office, 2 days at home), annual discretionary bonus, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 5% pension contributions matched by the company.
Notice to Recruiters
Vaccitech s internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees
Vaccitech plc is a fast-growing biotech company. At only five years old we already have a development portfolio of six products, a partnered product that is in commercial production that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We run clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.
In December 2021 Vaccitech acquired Avidea Technologies with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us US operational presence in Maryland, complements Vaccitech s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. From March 2022 Vaccitech's UK headquarters will be moving to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.
The role
The role will work closely with the Director of Quality and Vaccitech staff to advise and oversee GCP and GMP compliance in the Clinical, Laboratory and Manufacturing group in accordance with local and international quality requirements. The role will include review and approval of key quality documents, including SOPs, Policies, Forms, batch documentation, validation / qualification documentation and Quality Agreements.
Key areas of responsibility will include, but are not limited to:
Supporting the Director of Quality in the management of the Vaccitech Quality Management System (QMS) to include SOPs, Deviations, CAPA, Change Control, Audits, risk management;
Ensuring good practices (GxP) are communicated, adopted and implemented throughout the organisation by maintaining current knowledge of local and international regulations;
Providing Quality expertise and oversight internally to project teams and other departments;
Working with the Director of Quality to ensure Vaccitech maintains Inspection Ready Status at all times;
Acting in the capacity of Quality Representative for all tasks defined in the quality system documents;
Establishing Key Performance Indicators (KPI) and producing regular Quality Reports for Management;Delivering Quality training to staff to include induction and refresher training for GCP and GMP
Auditing
Supporting the risk-based annual External/Contract Service Provider (CSP) audit programme and maintaining the Approved Supplier List;
Supporting the risk-based internal audit programme by creation of an annual internal audit schedule;
Managing the study specific audit programme;
Performing internal, CSP, clinical site, CDMO and study specific audits;
Key Document audits, e.g., validation reports, regulatory submissions, clinical essential documents, Clinical Study Reports, etc.;
In addition you will be:
Supporting and deputising for the Director of Quality (i.e., delegate);
Supporting the Director of Quality to ensure that the company s statutory and legal obligations are discharged to satisfy current legislation relating to Quality/GxP;
Ensuring compliance with GCP, GMP and other regulatory requirements;
Line management responsibilities and supporting the development for junior QA staff
Qualifications and/or experience required to perform the role
Minimum of four years quality assurance experience in a pharmaceutical or Biotechnology organisation;
At least three years experience as a Clinical Quality Assurance Auditor;
Degree in a scientific subject (preferably a Biological Science);
Good communication and interpersonal skills with the ability to communicate effectively with staff / and sub-contractors at all levels and different cultures;
Good experience of conducting internal and external audits (on site and remotely);
Detailed knowledge of GCP is mandatory;
Detailed knowledge of MHRA (essential), EMA and FDA standards (desirable)
Knowledge of GCP for laboratories is desirable;
Good knowledge of GMP (with reference to Annex 13 - Investigational Medicinal Products);
Experience in delivering training to staff on Quality topics;
Experience in working with or implementation of an electronic QMS is desirable;
A good working knowledge of MS Office including Word, Excel, Outlook and PowerPoint;
A flexible "can do" attitude;
Ability to work independently;
Pragmatic and adaptable;
Line management experience desirable;
Willingness to undertake some travel as part of auditing or to visit Vaccitech North America Inc. site;
What We Can Offer
Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer flexible forms of hybrid working (3 days in the office, 2 days at home), annual discretionary bonus, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 5% pension contributions matched by the company.
Notice to Recruiters
Vaccitech s internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees