Job Description

Lead the Distribution Quality Support
group to:

  • Own GDP processes and procedures applicable to
    multiple entities/markets. Collaborating with RPs and equivalent
    Country Quality Managers, drive continuous improvement and
    harmonization/optimization of processes / procedures.  

  • Develop and enhance training materials related
    to GDP as
    needed.               

  • Define and monitor standard quality KPI and
    review quality indicators with recommendation for actions for
    improvement.  Attend and develop College Park Distribution related
    Quality Management Review meetings

  • Collaborate with appropriate RP and
    Country Quality Managers to provide quality oversight for cold chain
    validation activities. 

  • Act as QA technical contact point with
    Country Quality Managers at affiliates. Provide guidance, drive and
    monitor Quality issues related to cold chain and GDP to resolution within
    the company and with external parties. 

  • Collaborate with APIOUC (Ireland) Responsible
    Person, review documentation including but not limited to Quality
    Agreements, change controls, deviations, validation documentation, SOPs
    and specifications

  • Provide support and expertise for the
    preparation of regulatory submissions, inspection readiness activities,
    during health authority inspections including interaction with inspectors,
    responses to inspection observations, to monitor progress of follow up
    actions.

  • Support APIOUC (Ireland) Responsible Person
    and UK Responsible Person to ensure compliance with the general conditions
    of the company Wholesale Distribution Authorisations and ensure compliance
    with the requirements of GDP.

  • Support work streams relating to market
    monitoring and investigations relating to the Falsified Medicines
    Directive.

  • Support mergers and acquisitions by performing
    due diligence inspections, gap analysis and risk assessments on prospective
    business opportunities

  • Support audits of contractors executed
    according to the company external audit program

  • Project Management of Key Project Schedules
    across the network.

  • Demonstrates core Values through
    management style

  • Any other duties as required by management.


Requirements

Qualification: 

  • Minimum 5 years in international
    pharmaceutical and/or biotech industry with increased level of
    responsibility

  • Minimum 2 years of experience in QA and
    GDP

  • Experience in managing contractors
  • Sound awareness and understanding of
    pharmaceutical business, especially with regards to quality and regulatory
    requirements

  • Demonstrated success records in
    improvement processes

  • Ability to operate efficiently in a
    complex matrix organization and international environment

  • Management skills for management of a
    team of Specialists/Sr. Specialists,

  • Strong mature leadership and
    interpersonal influencing skills

  • Ability to represent the company and to
    negotiate at different levels contacts both internally and externally

  • Strong verbal and written communication
    skills with well-structured communication and presentation ability to
    various audience levels.

 

Education: 

  • Academic degree in natural or
    applied sciences (Pharmacy, chemistry, biotechnology, engineering).

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