QMS & Compliance Lead
- Experience Level
- Senior Management
An exciting opportunity has arisen for a QMS & Compliance Lead 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 QMS & Compliance Lead 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 and easy access to London and the south coast;
- Onsite canteen;
- Onsite nursery.
The successful candidate will be joining the Quality Management Team. As a QMS & Compliance Lead for Porton Biopharma you will assist with the delivery of autonomous and innovative leadership.
- Lead the QMS & Compliance teams to deliver compliant Quality systems, and develop a world-class QMS;
- Provide operational direction and leadership to a large team of GMP Quality professionals, Documentation control, & Archivist staff;
- Develop and manage the QA, GMP, & QMS programmes, policies, standards, and procedures to ensure conformance to the highest standards and regulatory agency requirements (MHRA, EU, FDA etc.);
- Establish processes and systems that support collaboration, compliance and are simple and effective;
- Lead and support where required with regulatory inspections;
- Further develop, implement and manage processes that align with, and drive, effective systems for change control, deviations and investigations, complaints, recalls, risk management and CAPA;
- Oversee GMP Quality system performance metrics, analyse compliance data and coordinate the necessary Quality reporting and escalation responses;
- Manage the processes for the Quality Management Review Board, Change Control Review Board and Risk Management forums;
- Provide expertise and guidance to senior management in the interpretation of global GMP regulations, ICH guidelines and internal policies and procedures;
- Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate SOPs, Code of Practices, Policies & Key Quality documents;
- Train, manage, and mentor QMS, GMP, & QA staff for the effective performance in PBL cGMP processes & compliance activities.
- Have current right to work in the UK;
- Experience managing in a successful business;
- Proven Leadership and Management skills in a matrix management environment;
- Practical understanding and working knowledge of GMP regulations and Compliance requirements, with the ability to provide applicable guidance;
- Extensive experience in the pharmaceutical or biotech industry, with extensive GMP QA experience within the FDA and/or EMA regulated environment;
- Demonstrable experience of GMP QA management of a team of QA Professionals;
- Comprehensive working knowledge of local, state, federal and international cGMP regulations; FDA/EU/ICH guidelines; validation standards, QMS and quality risk management principles;
- Proven experience with leading and hosting successful regulatory audits;
- Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors;
- Self-motivated and able to prioritize projects in a fast-paced environment.
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 email@example.com 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.com/privacy-policy/.
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