QP & Regulatory Compliance Manager

Additional Information

Location: Oxfordshire

Salary: Competitive + Bonus + Benefits

Hours: Full Time

Job Type: Permanent

Main Accountabilities

• Senior Leader for the Quality Function
• Fulfil legal requirement as MIA Holder and adhere to the guidance contained in Eudralex volume 4, Annex 16
• Maintain eligibility to be named as a QP on the required DSC MIA; this includes maintaining knowledge of the company Life Science QMS
• Review batch documentation, perform QP batch certification in accordance with the current Code of Practice, and deliver other QP related activities on behalf of clients;
• Facilitate updates and maintenance of all authorisations in conjunction with Quality Administrator and Quality Team (GMP) and include any training around authorisations
• Review and agree Quality/Technical Agreements in conjunction with Quality Management with Clients and Suppliers, and ensure full compliance is achieved against these agreements
• Support the Quality Director with the delivery of the Quality and Regulatory Agendas at site/business level, ensuring harmonisation of best (GMP/GDP/ISO) practices is rolled out across all UKI Life Sciences sites
• Support the Commercial & Packing Services Business by performing structured QP tasks ensuring that client specifications are followed, and the business is compliant with approved procedures, GxP expectations and MHRA guidelines
• Support the delivery of the Quality Strategy for CTL, PS and Commercial Pharmaceutical on an annual basis as well as ensuring contractual KPIs are monitored, reviewed and achieved on a monthly basis, as appropriate
• Support business growth by participating on client project implementations from a Quality and Regulatory perspective
• Build and maintain excellent working relationship with our clients, peer groups, as well as with relevant regulatory and professional bodies
• Attend and present as required Quality and Regulatory compliance status at management and business reviews both internally and with clients
• Facilitate regular reviews with Quality Leadership Team and Responsible Persons
• Liaise with QA/QC and client Quality teams in relation to investigation and resolving “deviations” which may occur during manufacture or within DSC’s chain of custody
• Attendance at Regulatory Inspections as required
• Undertake internal and external audits as requested and support hosting external audits where required
• Contribute to content creation and the delivery of GMDP training
• Maintenance of SOP training status for QPs
• Facilitate regular training and awareness activities with QA and rest of the business around topical regulatory matters and/or processes e.g. validation, licences, serialisation, annex 16, IMPs
• Raise Quality and Compliance awareness across operational and non-operational teams and functions in line with GMDP, ISO 9001 and ISO 13485 requirements

Experience and Qualifications

Functional

• At least 5 years experience as a QP in areas stipulated by respective authorisations
• At least 5 years Line Management experience
• Market and industry knowledge in particular around GxP regulatory requirements and GxP compliance QMS and associated procedures.
• Ability to advise clients on how to navigate through the CT process
• 5 years+ experience in Pharmaceutical Manufacturing and Logistics
• Experience in Medical Devices, Cold Chain, Validation, Transportation and Packaging preferred

Education And Qualification

• Degree level education (Science degree)
• At least 5 years experience as a Qualified QP in areas stipulated by the respective authorisations
• Eligibility for nomination of a Qualified Person (Commercial and investigational medicinal products)
• Logical, excellent attention to detail, methodical and good communication and organisational skills
• Demonstrable Continuous Professional Development