Head of Quality Control (Pharmaceutical)
- Experience Level
An exciting opportunity has arisen for a Head of Quality Control to join Porton Biopharma, a leading biopharmaceuticals company located on the historic Porton Down site, in the picturesque countryside of Salisbury, Wiltshire.
Porton Biopharma Limited (PBL) is a limited liability company, established in 2015, to commercialise pharmaceutical development and manufacturing capabilities. Our mission is to protect patients’ health through the quality-assured development and production of biopharmaceuticals. We develop new vaccines, therapeutic proteins and enzyme products, and manufacture our own licensed biopharmaceutical products, Erwinase® and the UK’s Anthrax Vaccine.
We offer specialist expertise in the development of both manufacturing and analytical processes for use with biological pharmaceutical products. Particularly in taking concepts from the research laboratory and progressing them through the various stages of scale-up and process development to manufactured product for licensed supply or clinical trial.
Our employees join us safe in the knowledge that their skills and experience are contributing to a valuable purpose. This is an excellent environment for the right person to build their biopharmaceutical career.
The Head of Quality Control will be in receipt of a competitive benefits package, including:
- 30 days of holiday, plus 8 bank holidays;
- On the job training, and genuine opportunities for growth and advancement;
- Generous pension scheme;
- Access to online discounts;
- A work environment based in the beautiful Salisbury countryside, with free on-site parking; easy access to London and the south coast
- Onsite canteen.
- Onsite nursery
The successful candidate will be joining the Quality Division. As the Head of Quality Control for Porton Biopharma, the post holder will lead and manage a team engaged in Quality Control in both Analytical Chemistry and Microbiology testing in line with regulatory requirements, safety standards and within budget constraints. To ensure that changes in world-wide pharmaceutical regulations are recognized and incorporated into QC working practices.
- To ensure that all testing is carried out with properly developed validated and approved methods.
- To ensure that the facilities are maintained to meet all necessary operational standards and regulations.
- To lead the regular review of Safety standards for the QC laboratories and related equipment.
- Utilising input from relevant functions, Operational Project and Production management, take all decisions relating to the routine operations of the facilities.
- To ensure sufficient suitably trained staff are in place to carry out the testing and supervision of the testing, procedures and equipment.
- To lead the training, management, appraisal and mentoring of staff to ensure performance, safety and training standards are achieved.
- To review and implement an organisation structure and work patterns fit to meet the needs of process and production and where necessary propose and implement change.
- To recruit suitable staff and to plan staff development succession planning to meet current and future needs of the process and production.
- To act as the lead expert on Analytical Methodology and ensure that all laboratory practices, methods and reporting procedures are compliant with Pharmacopoeias and international guidelines as developed by ICD and applicable ISO standards.
- To manage the capacity for all Quality Department Testing through the Capacity and Demand Manager to meet agreed dates for completion.
- To ensure that all processes and procedures are documented and current for the operation of the facility.
- To monitor performance and capacity of test equipment and via contribution to the Pharmaceutical Operations Budgets, recommend and provide justification for new investment.
- Have current right to work in the UK;
- Be educated to degree level in relevant life science or equivalent or have significant experience
- Substantial knowledge and understanding of MHRA and FDA regulatory requirements in relation to QC
- Extensive Managerial experience of pharmaceutical QC Laboratories
- Experience of in process and final product QC testing of biopharmaceutical products
- Experience of analytical method development and validation
- Problem solving skills and ability to respond to sudden unexpected demands
- Demonstrated capability to plan over short, medium and long-term timeframes and adjust plans and resource.
- Comprehensive experience of project principles techniques and tools such a Prince 2 and Managing Successful Projects
- Must be able to priorities own work effectively and be able to direct activities of others. Experience of managing and motivating a team and reviewing performance of the individuals.
For this unique opportunity to join our team and develop your biopharmaceutical career experience, please submit your CV and a covering letter. You should outline the skills and experience you have, which are relevant to the post for which you are applying. For more guidance on role requirements, please visit our website, portonbiopharma.com/careers, to download the Job Description.
PBL is an equal opportunities employer, celebrating and encouraging diversity of applications
Porton Biopharma Ltd is committed to the fair and transparent processing of applicant data. To enable the Company to assess suitability for advertised roles, we will collect the following data: name and contact details, previous work experience and history, qualifications, education, right to work in the UK eligibility, present salary and equal opportunities. The Company reserves the right to collect this data under article 6(1)(B) of the GDPR.
Applicants applying for this role will have their data collected and held securely, and confidentially within Company IT systems which are compliant with GDPR. Data will be shared with the HR department, recruiting managers and recruiting panel.
The Company will hold applicant data on file for 12-months post the vacancy being successfully filled. Candidates are welcome to request that their personal data is removed prior to this date, and should contact recruitment@portonbiopharma if they wish to exercise this right. The Company complies with all data subject rights as outlined on the ICO Website. For more information, please refer to our privacy notice: https://www.portonbiopharma/privacy-policy/.
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