Collette Flanagan
London
Summary
Highly experienced Quality Assurance professional with almost 20 years experience in various sectors of the pharmaceutical industry. Strong management experience with a robust background in all aspects of Quality Assurance and Compliance. Solution focused with a keen ability to make quick and informed decisions with an aim to minimise patient impact whilst never compromising on quality.
Overview
18
18
years of professional experience
3
3
years of post-secondary education
1
1
Certification
Work history
Senior Specialist, Commercial Quality
ADVANZ PHARMA
London
03.2023 - Current
- Lead major Quality related issues to ensure minimal impact to the patient and business
- Direct support to the Qualified Person (QP)
- Provide Quality guidance and support to cross functional teams
- Lead and support Quality interactions for Health Authorities
- Act as trainee Responsible Person (RP) for the fulfillment of GDP requirements
- Review and approval of QMS activities
Senior Manager, Quality
ADVANZ PHARMA
London
02.2019 - 02.2023
- Management of Quality Compliance & Batch Release teams
- Direct management of 3 first line managers (+8 indirect)
- Responsible for ensuring CMO compliance to Marketing Authorisation, including the final review and approval of compliance gap assessment, risk ratings, next steps and escalation
- Responsible for ensuring compliant and timely release of product to the market
- Key Quality contact for a number of CMOs for resolution of critical issues
- Lead supplier meetings for Quality department to resolve issues and promote continuous improvement
- Lead resolution of Quality critical issues to minimise patient impact, working with CMOs, technical, supply chain and commercial to understand impact on stock/market position as a result of issues
- Identification and implementation of process & team improvements
- Establishment, tracking and reporting of KPIs for team
- Responsible for setting and monitoring Quality budget
- Approval of deviations, change controls, PQRs etc.
- Audit/Inspection support
GMDP Auditor (IRCA qualified)
ADVANZ PHARMA
London
06.2017 - 02.2019
- Qualification of 3rd party suppliers & CMOs (sterile & solid dose), API manufacturers, depots-onsite and desk top audits
- Report & observation compilation, risk assessing and CAPA tracking
- Escalation of critical findings to QPs
- Liaising with suppliers to remediate auditing findings
- Establishing annual audit schedule
- Providing audit SME support during introduction of new products/CMOs
- Improving and streamlining processes
- Internal auditing
- Training of new Auditors
Site Quality Manager
Baxter Healthcare
London
09.2015 - 06.2017
- Responsible for Quality at Aseptic Compounding Unit
- QA team management - 4 QA Associates
- Oversight of calibration, PPM, Process Simulation (media fill) schedules, environmental monitoring activities-sampling and reading, APQRs
- Final review and approval of all quality documents-deviations, complaints, change controls, environmental monitoring trend reports, SOPs, validation protocols & reports
- Compiling metrics and trend reviews for Unit Quality meetings & UK & Ireland management review meetings (MRM)
- Representing Quality at UK & Ireland MRM
- Compiling sterility assurance risk assessments
- Providing guidance and acting as SME on issues relating to and impacting quality
- Providing ongoing deviation and root cause analysis training
- Identified and led process improvements
- Hosting audits/inspections, compiling audit responses, and managing actions
- Escalating major quality issues to senior management and MHRA (yellow card)
Quality Systems Team Leader
Abbott Diagnostics UK
London
09.2014 - 09.2015
- Team management-5 CAPA/LIR Specialists
- Managing site CAPA system to ensure compliance and timelines
- Collation and review of Quality metrics
- Reporting of Quality System metrics to Quality Manager and Division
- Review and approval of deviations, CAPAs
- Training of staff on CAPA related processes
Supplier Quality Auditor
Almac Clinical Services
Craigavon, NI
12.2012 - 09.2014
- GMDP auditing of service providers-distribution depots, calibration service providers, label manufacturers
Quality Assurance Team Leader
Almac Clinical Services
Craigavon, NI
04.2012 - 12.2012
Senior QA Associate
Almac Clinical Services
Craigavon, NI
12.2009 - 04.2012
Biochemist
Olympus Life and Material Sciences
Ireland
04.2007 - 05.2008
Developmental Process Specialist
Abbott Diagnostics Ireland
Ireland
10.2005 - 04.2007
Education
Bachelor of Science - Medicinal Chemistry
Queen's University of Belfast
Belfast 09.2002 - 06.2005
Skills
- Well rounded QA professional
- Experienced Senior Manager
- Confident decision maker
- Confident in assessing risk and mitigation
- Sterile (Aseptic) experience
- Experienced IRCA qualified Auditor
- Solution and improvement focused
Certification
- Pharmaceutical GMP Auditor/ Lead Auditor training course, IRCA certified: Inspired Pharma
- Sterile Products training: Inspired Pharma
- Data Integrity: Inspired Pharma
- Cleaning Validation: RSSL
- QP Analysis and Testing: RSSL
References
References available upon request.
Timeline
Senior Specialist, Commercial Quality
ADVANZ PHARMA
03.2023 - Current
Senior Manager, Quality
ADVANZ PHARMA
02.2019 - 02.2023
GMDP Auditor (IRCA qualified)
ADVANZ PHARMA
06.2017 - 02.2019
Site Quality Manager
Baxter Healthcare
09.2015 - 06.2017
Quality Systems Team Leader
Abbott Diagnostics UK
09.2014 - 09.2015
Supplier Quality Auditor
Almac Clinical Services
12.2012 - 09.2014
Quality Assurance Team Leader
Almac Clinical Services
04.2012 - 12.2012
Senior QA Associate
Almac Clinical Services
12.2009 - 04.2012
Biochemist
Olympus Life and Material Sciences
04.2007 - 05.2008
Developmental Process Specialist
Abbott Diagnostics Ireland
10.2005 - 04.2007
Bachelor of Science - Medicinal Chemistry
Queen's University of Belfast
09.2002 - 06.2005
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