Provide leadership and resource management support to Corporate Quality and the designated Affiliate
Ensure that 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 cluster compliance on a regular basis
Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GDP/GXP/PV audits.
Provide Quality Expertise and leadership to the designated Affiliate and lead local/regional 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 procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
Act as Quality liaison between the local operational groups and Corporate Quality for GDP/GXP/PV functions and activities.
Partner with local, regional and global operational groups to foster a proactive approach to compliance.
Provide Quality Oversight for Homecare Providers (Patient Support Programmes) and vendors in UK/IRE
Act as the primary Responsible Person (RP) and ensure that the provisions of the licence are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01),
Ensure a quality management system is implemented and maintained;
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;
Approve any subcontracted activities which may impact on GDP;
Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place;
* 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.
* Strong leadership ability.
* 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.
* Exceptional communication and interpersonal skills
* Ability to work globally in a matrix environment
* Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
* Ability to freely travel up to 30%, (domestic and international)
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.