Senior Manager, Quality Country Gxp Compliance
hace 4 semanas
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
**Senior Manager, Quality Country GxP Compliance (Spain)**
**Location**: Barcelona
**Report to**: Director, Regulatory & Quality Affairs Iberia
**Position Summary**
In addition the Senior GxP Compliance Manager will act as the Quality expert of Spain and work together with RP Portugal as a cluster.
**Principal Responsibilities**
- Partner and collaborate with leads and colleagues to ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards.
- Provide leadership and resource management support to Regulatory and Quality Affairs Spain.
- 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 cluster compliance on a regular basis.
- Ensure Alexion is kept fully informed of new or emerging GMP and regulatory changes in the region.
- 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 to the designated affiliate and lead local/regional Quality activities.
- In collaboration with the Director RQA Iberia, weigh and communicate quality and compliance risks as appropriate.
- Monitor GDP, GXP and Pharmacovigilance to regulations and Alexion’s procedures and communicate CAPAs and action plans to the Director RQA Iberia.
- Act as Quality liaison between the local operational groups and Corporate Quaity for GDP/GXP/PV functions and activities.
- Partner with local, regional and global operational groups to foster a proactive approach to compliance.
**Responsible Person (RP) Responsibilities**
- Act as back up Responsible Person (RP) on applicable distribution licenses in Portugal and ensure that the provisions of the licenses are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01), as follows:
- 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 activites 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
- Keep appropriate records of any delegated duties
- Decide on the final disposition of returned, rejected, recalled or falsified products
- Approve any returns to saleable stock
- Ensure additional requirements imposed on certain products by national law are adhered to
- The back up of the Responsible Person should fulfil their responsibilities personally and should be continuously contactable. The back up Responsible Person may delegate duties but not responsibilities.
**Qualifications**
- Bachelor’s degree, preferably in life sciences. Advanced degree (PharmD or PhD) preferred.
- 8+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
- Thorough knowledge of applicable local and global regulatory requirements required forGXP 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 influence senior management, peers, and other colleagues without directreporting lines
- Ability to work in a dynamic environment and to constantly redefine the scope ofresponsibilities in alignment with compliance and business needs
- Ability to multi-tasks and prioritize work.
- Strong organizational ability.
- Demonstrable computer skill.
- Ability to freely travel up to 30% (domestic and international).
AstraZeneca completed its acquisition of Alexion, marking the creation
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