Management Manager

ANGELA SMITH

Mobile: +** (0-781*-******

e-Mail: **********@******.***

CAREER OVERVIEW

A business-focused professional within a large global pharma; with a

motivational approach to work and offers a pragmatic "hands-on" approach

and expert functional guidance. Capable of developing strong, co-operative

relationships at all levels, demonstrating excellent auditing and line

management skills (including manager of managers) and clear communication

with both internal and external clients. Extensive national and

international experience, gained during a career with perspectives both

from a large Pharma and CRO environment requiring a commercial awareness.

Experience in risk based and traditional/standard auditing methods.

EDUCATION - UK

HIGHER DEGREE: MASTER OF SCIENCE - CLINICAL AND PHARMACEUTICAL SCIENCES;

HATFIELD UNIVERSITY, HERTS (2000)

Degree: Batchelor of Science (Honors) Molecular Biology; Portsmouth

University, Hampshire (1998)

Diploma: Pharmacy Diploma; Society of Apothecaries' of London (c.1993)

PROFESSIONAL EXPERIENCE

BOEHRINGER-INGELHEIM, BERKSHIRE (MAY 2013 - CURRENT)

Auditor (GCP)

- Responsible for Planning, conducting and reporting routine and complex

clinical audits, including risk based auditing (at process and site

level)

- Support GCP inspections by regulatory agencies relating to clinical

research activities

- Ensure early identification and escalation of quality initiatives to

support research activities

- Identify areas of risk in liaison with other functions and develop

appropriate audit programmes

- Ensure that CAPAs are identified and followed up

- Support the compliance and training functions of QM-M&R

- Responsibility for all activities within of QM-M&R for specific counties

regions, in order to ensure robust audit plans and inspection

preparedness, ensuring BI meets both business needs and upholds

regulatory compliance

Covance Maidenhead, Berkshire (January 2012 - May 2013)

Associate Director/Country Head, UK & Ireland

- Responsible for resource management, identifying strategic staffing needs

and conduct staff recruitment and talent development

- Responsible for review of billable hours and utilisation within the UK

and mitigate risk

- Local key contact for business development and client relations

- Responsible for compliance of Covance hospital contracts with local

regulations on Clinical trials and local fiscal regulations;

responsibility for the preparation of Covance office audits by local or

central Regulatory Authorities and clients.

- Effectively communicate management strategies, policies and procedures in

conjunction with leadership teams and develop and measure key performance

indicators with managers and clinical operations staff

- Have GCP oversight of clinical operations managers and clinical

operations staff within the UK & Ireland and act as local regulatory

expert

- Line management of assigned managers and staff nationally (field and

office based) in UK & Ireland

- Conducting detailed performance reviews and management of assigned direct

reports and responsible for line of sight goals and 'shoves & tugs'

discussions

- Responsible for appropriate management and resolution of performance

issues.

- Co-ordinate and conduct on site accompanied field visits (CQC visits)for

Clinical Operations staff and ensure all deliverables, including CAPAs

are resolved

Covance Maidenhead, Berkshire & Crawley, West Sussex (May 2009 - January

2012)

Senior QA Manager

- Plan, conduct and report clinical audits for clients to ensure compliance

with ICH GCP, SOPs (client and Covance) and relevant regulatory

guidelines and country specific laws:

o phase I-IV study audits

o vendor audits and assessments

o process and internal audits

o track all audit reports/findings/CAPAs from client and

internal audits successfully within specified timeframes (92%

targets met)

o assist QA senior management with compiling global audit

program

o considered as Covance TMF expert

- Global QA Lead for specific clients

o to build secure effective, honest and open relationships

which lead to global consistency across all client projects

o ensuring contracted budgets are in line with client focus and

expectations

- Provide support and advice to internal management and project teams on a

worldwide basis

o to advise on SOP/regulatory issues

o provide advise and training for auditors and clinical

research associates (clinical monitors)

o process improvement/SOP reviews and updates

- Provide support to junior QA team members across all 3 regions (EU,

USA & Asia/PAC)

o peer reviews conducted

o assisting with issue resolution and training

o providing feedback for PDP reviews

- Support Covance in GCP inspections by regulatory agencies relating to

clinical research activities

o leading the 'backroom' activities

o conducting scribe duties

o inspection training for non-QA staff

GSK Welwyn, Hertfordshire (Mar 2005 - Apr 2009)

Senior Auditor - responsibilities as above

GSK Welwyn, Hertfordshire (Jan 1999 - Mar 2005)

Deputy Head Dispensary

SKILL SUMMARY

- GOOD UNDERSTANDING OF ICH GCP AND OTHER DIRECTIVES E.G FDA GUIDELINES, EU

DIRECTIVE AND UK STATUTORY INSTRUMENT

- Proven leadership and management skills

- Pragmatic work approach

- Excellent time management and organisational skills

- Good eye for detail

- Excellent negotiator and communicator

- Able to accommodate business travel

- Successful mentor for all levels of staff

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