The Senior Specialist Quality, PFG (CEE and Russia) will be responsible for maintaining the Quality oversight and day to day operations of the Partnership for Growth (PFG) partner in the Central European and Russian markets.
This role will act as the day to day contact for our partner in the region, support expansion in the territory covered by the partnership, and new product launches.
They are expected to have strong experience in GxP’s, quality systems and Pharmacovigilance areas as well as the ability to function independently and in a matrix environment.
Partner and collaborate with leads and colleagues to ensure the on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards to the International organization.
Provide Quality support for territory expansion and new product introductions. This includes the maintenance and necessary updates to QAG (Quality Agreements), initiation of audits, and support of required Quality documentation.
Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GDP, GXP and PV guidelines.
Provide internal auditing resource to assess Partner compliance on a regular basis
Stay up to date and informed of new or emerging GMP and GVP changes.
Manage the review and implementation of Quality Improvement / remediation plans for the Partner through Corporate as well as internal GDP / GXP / PV audits
Provide Quality Expertise and leadership to PFG COE Area Director and their team and lead associated Quality activities
In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
Monitor GDP, GXP and Pharmacovigilance compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
Partner with local, regional and global operational groups to foster a proactive approach to compliance.
Ensure adherence to Alexion procedures to vendor oversight, periodic KPI review and appropriate risk assessment and mitigation.
Support quality management oversight and maintenance in adherence with US / EMA and local regulations
Work with Partner to collect and act on Regulatory Intelligence
Focus on the management of authorized activities and the accuracy and quality of records
Ensure initial and continuous training programs are implemented and maintained
Coordinate and promptly perform any recall operations for medicinal products
Ensure relevant customer complaints are dealt with effectively
Ensure suppliers and customers are approved and onboarded as per Alexion procedures
Approve any subcontracted activities which may impact on GDP or GVP
Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
Keep appropriate records of any delegated duties
Decide on the final disposition of returned, rejected, recalled or falsified products
Ensure additional requirements imposed on certain products by national law are adhered to
Work with the Area partner and Alexion management team to ensure a state of Inspection Readiness
5+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical / biotech industry.
Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
Ability to work in a dynamic environment.
Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
Strong knowledge of pharmacovigilance AE reporting systems and regulations required
Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
Excellent communication, interpersonal and stakeholder management skills
Ability to work globally in a matrix environment
Ability to influence management, peers and other colleagues without direct reporting lines
Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
Demonstrable computer skills (i.e., MS Office Applications, TrackWise, SAP, etc.)
Ability to multi-task and prioritize work
Strong organizational ability
Demonstrable computer skill
Ability to freely travel up to 10%, (domestic and international)
Bachelor's Degree in physical / life science or pharmacy; Advanced degree preferable