Title: Quality Director
Reporting to: Chief Technology Officer
Location: Milton Park
Line Management for: QA & QC personal
- PRINCIPAL DUTIES
The post-holder is responsible for the overall implementation, maintenance and management of the Pharmaceutical Quality Systems at the Emergex Vaccines development, manufacturing and testing site at Milton Park, Abingdon. This candidate will be the most senior quality position at the company and responsible for overall leadership of the Quality Department
- Provide direction supporting Quality Assurance and Quality Control personnel to ensure Quality planning is aligned with corporate strategic objectives and current pharmaceutical regulation.
- Development and oversight of the Quality Management System (QMS).
- Analysis, evaluation, and presentation of quality-related data concerning business programs, capabilities, problems and trends to the senior management team.
- Co-operation with senior management in promoting compliance with company policies and Standard Operating Procedures (SOPs).
- In the collaboration with the Manufacturing Director, oversight of the manufacture, testing, storage and distribution of pharmaceutical products in compliance with The Human Medicines Regulations (SI 2015/1916) and guidance governing pharmaceuticals, ensuring that operations do not compromise the quality of starting materials, intermediates, or medicinal products.
- Maintain regular surveillance of forthcoming legislation that may have an impact on the organisation. Together with the senior management team, plan and implement any changes to policies and procedures that may be required.
- Maintain the Pharmaceutical Quality System to comply with Good Clinical Practice and in compliance with Clinical Trials Regulations.
- Oversee and, where required, carry out supplier qualification audits and supplier approvals, assisting the Quality Assurance Manager in maintaining the required level of assurance in the Emergex supply chain(s).
- Oversight and maintenance of a recall and complaints system. With the Quality Assurance Manager, ensure full and prompt co-operation with national and international regulatory agencies in the event of product recalls, complaints, and / or product defects.
- Maintenance of the deviation and error reporting system and the required follow-up actions including impact analysis, root cause analysis, CAPA, and effectiveness checks.
- Management and oversight of the integrity of the quality data/tools such as master data spreadsheets and templates and archiving paper-based data such as validation packs, batch records etc.
- With the Quality Assurance Manager, ensure that the provisions of any documented regulatory approvals are observed.
- Oversight of company facilities maintenance, (re)validation and calibration programs as required by supplier (service) approval, change control, and any reported deviations from specified acceptance criteria.
- Train, brief and prepare all cross-functional teams to meet required standards expected by regulatory inspections by organising mock audits
- Act as contact point and receive all external audits and regulatory inspections related to areas of quality management and regulatory approval.
- Such other duties as senior management may from time to time reasonably require.
- EXPERIENCE & QUALIFICATIONS
- Batchelor’s degree in a life science.
- Must have at least ten years’ professional experience in pharmaceutical quality management and will be able to demonstrate technical knowledge in areas of pharmaceutical manufacturing, quality control, release testing, and legislation regarding the manufacture, testing, storage, and distribution of medicinal products.
- Experience in establishing and implementing quality systems, as well as the maintenance of them
- Full working knowledge of The Human Medicines Regulations (SI 2015/1916) and Eudralex Volume IV parts I and II. Additional knowledge of Good Distribution Practices (GDP) 2013/C 343/EC desirable.
- Must understand the principles of quality management and will be conversant with ICH Quality Guidelines Q8, Q9 and Q10.
- Should have knowledge and implementation experience in the following legislation and guidance:
- The relevant provisions of the Human Medicines Regulations (SI 2015/1916).
- Directive 2001/83/EC as amended.
- EU GMP Directive 2003/94/EC as amended.
- EU guidelines on GDP 2013/C 343/EC and UK regulations on Good Distribution Practice.
- The European Clinical Trials Regulations 536/2014.
- Experience managing a small team of quality personal.
- PROFILE OF THE CANDIDATE
- Strong interpersonal skills and the ability to effectively communicate within a team environment.
- Highly driven and able work under time pressure.
- Effective investigation skills.
- Creative and accommodating thinking in the context of regulatory compliance.
- Willingness to accommodate a company personal development plan.