Lead the Distribution Quality Support
- 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
- 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
- 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
- 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
- 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
- Support mergers and acquisitions by performing
due diligence inspections, gap analysis and risk assessments on prospective
- 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
- Any other duties as required by management.
- Minimum 5 years in international
pharmaceutical and/or biotech industry with increased level of
- Minimum 2 years of experience in QA and
- Experience in managing contractors
- Sound awareness and understanding of
pharmaceutical business, especially with regards to quality and regulatory
- Demonstrated success records in
- 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.
- Academic degree in natural or
applied sciences (Pharmacy, chemistry, biotechnology, engineering).