Website Ref: TPM4064
A QA Manager is required for a biotech company in West Dublin. The successful candidate will manage the Quality Distribution Operations team. Provide Quality Business Partner support to Global Supply Chain in Logistics, Customer Operations, and Commercial Distribution functions in College Park. This position supports the responsible persons and equivalent country quality managers in distribution related quality management systems support including but not limited to act as QA technical contact point with Country Quality Managers at affiliates, own GDP processes and procedures applicable to multiple entities/markets. The incumbent will act as a Deputy RP on the Wholesale Distribution Licence.
- Oversee Quality Distribution operations for the supply & distribution of product to global markets.
- Provide line management support for a team of Quality Specialists/ Snr. Specialists.
- 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.
- Define and monitor standard quality KPI and review quality indicators with recommendation for actions for improvement.
- Attend and support the development of material for Quality Distribution related Quality Management Review meetings Develop and enhance training materials related to GDP as needed.
- 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, returns, validation documentation, SOPs and specifications.
- Providing Quality oversight for GxP Vendors including 3PL warehouses, logistics partners & other service providers.
- Oversee the Distribution QA release of batches at distribution centres for onward supply.
- Provide Quality oversight for Distribution complaints (SCARs) with 3PL warehouse and logistics providers.
- Provide Quality Distribution support for global product launches.
- 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 to ensure compliance with the general conditions of the Wholesale Distribution Licence and ensure compliance with the requirements of GDP, including but not limited to acting as deputy RP, as required.
- Support work streams relating to market monitoring and investigations relating to the Falsified Medicines Directive.
- Support audits of contractors executed according to 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.
Qualifications & Experience:
- Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
- Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
- Minimum 5 years of experience in Quality Assurance and Good Distribution Practices.
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
- Thorough knowledge of local GDP and global regulatory requirements Deputy RP experience is preferred.
- 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.
To apply for this job email your details to firstname.lastname@example.org.