Quality Assurance Manager

Perennial Pharma Ltd

Whitstable

Hybrid

GBP 70,000 - 90,000

Full time

9 days ago
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Job summary

Perennial Pharma Ltd is seeking a Quality Assurance Manager to lead quality across the business, owning the QMS, ensuring medicines are produced, imported, stored and distributed to GMP, GDP and MAH standards. You will partner with the MD, RP and senior management to strengthen the quality culture and regulatory readiness.

The role requires extensive QA experience in GMP/GDP licensed operations, RP eligibility, and oversight of CMOs/3PLs.

Qualifications

  • Degree in pharmacy, chemistry, biology or a related life science, or equivalent experience.
  • Significant QA/quality assurance experience in GMP/GDP licensed operations.
  • Experience with RP eligibility and MHRA interactions is advantageous.
  • Experience with CMOs, 3PLs and laboratories and audit support.
  • Strong data integrity understanding (ALCOA+).

Responsibilities

  • Own and continually improve the QMS in line with UK GMP and GDP.
  • Lead deviations, CAPA, change control and investigations.
  • Oversee contract manufacturers, laboratories, 3PLs and transport providers.
  • Coordinate Product Quality Reviews and support QP batch certification.
  • Host MHRA inspections and manage inspection responses.
  • Manage complaints, quality defects and recalls, ensuring license compliance.
  • Maintain SOPs and data integrity across the quality function.

Skills

QA management
GMP/GDP
MHRA inspections
Data integrity
Quality leadership
Audit management
RP eligibility

Education

Pharmacy/Life science degree

Tools

Electronic QMS
QMS systems

Job description

Quality Assurance Manager

Perennial Pharma Ltd - Hybrid Role

Permanent, full time, 37.5 hours per week, Monday to Friday

About us

Perennial Pharma is a UK based generic medicines company, formed in2019and built on a simple idea, toidentify, develop, manufacture and supply high quality, affordable medicines for the UK market. Perennial is a rapidly growing company and as part of its continued expansion is looking to build upon its committed and dynamic team.

Our slogan is "defining, not following", and our values of tenacity, courage, integrity,commitmentand fun shape how we work every day. Quality sits at the front of our thinking, and this role is central to that.

The role

As our Quality Assurance Manager,you'lllead quality across the business, reporting directly to our Managing Director.You'llown and manage our Pharmaceutical QualitySystem day to day, making sure the medicines we supply are made, imported, stored and distributed in line with GMP, GDP and our Marketing Authorisations.You'llwork closely with our MD, RP, our contracted QP, seniormanagementand the broader team to enhance our strong quality culture.

What you’ll be doing
  • Owning and continually improving our QMS in line with UK GMP and GDP
  • Managing deviations, CAPA and change control, and leading investigations and root cause analysis
  • Maintaining quality oversight of our contract manufacturers, laboratories, 3PL and transport providers, including qualification, auditsand Quality Technical Agreements
  • Supporting our contracted QP and coordinating Product Quality Reviews
  • Keeping us inspection ready at all times, hosting MHRA inspections and leading responses
  • Managing complaints, quality defects and recalls, andmaintaining compliance with our licence requirements
  • Overseeing SOPs, quality documentation, data integrity and our quality and GDP training programme
What we’re looking for
  • A degree in pharmacy, chemistry, biology or a related life science, or equivalent professional experience
  • Substantial pharmaceutical QA experience within GMP and GDP licensed operations (MIA and WDA(H))
  • Experience within a generic medicines business or a virtual MAH model
  • Eligibility to be named as Responsible Person and Responsible Person for Importation on a WDA(H), with experience of acting as, or deputising for, a named RP
  • Extensive working knowledge of UK GMP and GDP, the Human Medicines Regulations 2012 and related MHRA guidance
  • Experience of qualifying and overseeing CMOs, 3PLs and laboratories, conducting audits and supporting MHRA inspections
  • A sound understanding of data integrity principles (ALCOA+)
  • The confidence to make and explain sound quality decisions, and to hold a quality position under commercial pressure
  • Clear communication skills, strong attention to detail and the ability to work independently as a sole quality lead
It would be great if you also have
  • Experience of Product Quality Reviews and supporting QP batch certification
  • Recognised RP or GDP training, and lead auditor training
  • Experience of overseeing overseas manufacturers and importation
  • Experience of an electronic QMS

Closing date 31stOctober 2026

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