Principal Qms Compliance Lead

Aspire Pharma; Cambourne; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Company pension scheme

CSR days

Life Assurance

25 days’ holiday

Learning and development opportunities

progression opportunities

Company events

Cycle to Work Scheme

Private healthcare schemes

Job summary

Aspire Pharma is a rapidly growing UK pharmaceutical manufacturer based near Petersfield or Leicester. We are seeking a Principal QMS Compliance Lead to manage day-to-day QMS activities and ensure all Quality Control and Assurance tasks meet ISO 9001, ISO 13485, and ISO 14971 requirements.

The role includes line management, regulatory liaison, and leading internal audits. A Graduate with 4+ years QA experience is preferred, with strong English skills and MS Office proficiency.

Qualifications

• Written and spoken English with good communication skills.
• Time management abilities for coordinating QMS tasks.
• Attention to detail in document control and change management.
• Proven ability to lead a team and train staff.

Responsibilities

• Oversee and ensure QMS compliance across Irish/EU and UK GXP/ISO standards.
• Manage a Home team, ensuring staff have up-to-date roles and development plans.
• Report to Quality Department and Quality Compliance Manager on performance and issues.
• Liaise with Regulatory Authorities, Notified Bodies, and suppliers on changes and audits.

Skills

English

Communication Skills

Time Management

Attention to Detail

Team Management

MS Office

Q Pulse

Education

Graduate

Tools

Q Pulse

Job description

Competitive Salary & Company Benefits| Ideally located close to Petersfield or Leicester.
Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day). This is a full time, permanent role.
Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?
Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.

Do you want to be part of the journey?

If so, here is your chance! As a Principal QMS Compliance Lead, you are responsible for day-to-day management of designated QMS activities, and overseeing and ensuring all Quality Control and Assurance activities of the company in relation to QMS Compliance are carried out appropriately and in a timely manner. Acting as a direct line manager. Acting as deputy to the Quality Compliance Manager. Tasks and responsibilities listed are all possible tasks and responsibilities, as updated, it is identified that some of these tasks will only be undertaken when the job holder is formally trained, and signed off as competent in these areas.

Responsibilities

• QMS Compliance - maintenance of and compliance with the Aspire Pharma Limited Group’s Irish/EU and UK GXP/ISO 9001/ISO 13485/ISO 14971 QMS, where Irish/EU and UK GXP covers all UK and EU GXP guidelines referenced in APL’s Quality Site Master File/Quality Manual (SMF/QM001), including: staff training; documentation control; change control; non-conformance/deviations; corrective and/or preventive actions; acting as administrator of QPulse and maintaining Q Pulse and other QMS applied computer systems (e.g., ERP, RIMS, LMS), including review of updates and reports from software creators and implementation within the QMS; validation activities including maintaining the validation schedule; monthly checks for areas; approval of controlled documentation relating to area (e.g., SOPs, Work Instructions etc.); approval of non-conformance/deviations, CAPAs and change controls related to area; maintaining the business continuity plan/risk register; regulatory intelligence; internal audits, including acting as an internal auditor; self-inspections; management review; participation in inspections and partner audits of Aspire Pharma Limited as both auditor and auditee; monthly checks; licence variations; and launch activities for area.
• Line Management - Support and manage subordinates in their day-to-day activities; compliance of team to company SOPs and Quality Manual/Policy/Site Master File; ensure subordinates have up to date job descriptions, objectives, personal development plans and adequate training and understanding in order to fulfil their roles.
• Reporting – Reporting to Senior members of the Quality Department and the Quality Compliance Manager on team and company performance and workload, and any significant issues impacting the companies’ GXP/ISO compliance.
• Internal and External Liaison – Communicating effectively within the Aspire Pharma Limited Group, with Regulatory Authorities, Approved Bodies, Notified Bodies, vendors and customers to: facilitate timely implementation of changes to legislation/standards/guidance; investigation of non-conformances and deviations/CAPAs; timely launch of new products; schedule audits and report findings; and update/implementation of procedures.

Requirements

Knowledge & Skills

• Written and spoken English with good Communication Skills
• Time Management Skills
• Good Attention to Detail
• Team Management Skills
• Proficient in MS Office (including, word, excel and outlook)
• Proficient in Q Pulse or other electronic QMS

Experience Requirements

• Line Management experience
• Minimum 4 years experience working on Quality Assurance for Medicinal Products and Medical Devices (Class I and IIa desirable)
• Experience maintaining an ISO or EU and UK GXP Quality Management System desirable
• Experience managing Q Pulse or other electronic QMS

Education Requirements

• Graduate

Benefits

Why join us?
As well as a fantastic, inclusive company culture where employees are truly valued, and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:

• Company pension scheme.
• 2 Corporate Social Responsibility (CSR) days per year.
• Life Assurance cover and Employee Assistance Program.
• 25 days’ holiday plus bank holidays.
• Learning and development opportunities.
• Excellent opportunities for progression.
• Fantastic company events and celebrations throughout the year.
• Cycle to Work Scheme
• Private healthcare schemes