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EEMEA Cluster Quality Lead (Associate Director)Employee Type
Technical OperationsSearch Location(s)
United Arab Emirates - Dubai, Switzerland - Zug, Germany - Berlin, France - Boulogne-Billancourt, Ireland - Dublin, Italy - Milan, Poland - Warsaw, Turkey - Istanbul, United Kingdom - Basingstoke, United Kingdom - LondonDivision
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
• Act as Person In Charge to define the company GMP/GDP Program, oversee its execution by contractors and review and approve all data generated in accordance with current Country/Regional Cluster GMP/GDP Regulations.
• Provide QA leadership and technical support to external suppliers in order to ensure Shire’s commercial products are manufactured and tested in compliance of GMP/GDP.
• Oversee quality-related licences and functions for the local operation including pharmaceuticals, biologics, controlled drug activities, medical device, and plasma derived products.
• Accountable for health authority interactions within country /regional cluster as related to GMP/GDP activities including inspections and field actions.
• Accountable for launches and expansions execution in country or regional cluster.
• Supervision and development of local Country/Regional Cluster QA resources
Accountable for the development and improvement of Region Cluster/Country Quality Management System
• Ensure QMSs for responsible country and regional cluster are established that complies with Shire’ Global requirements and local requirements.
• Ensure harmonization of processes and procedures between Region Cluster/Country QA and Global requirements, processes and procedures.
• Leading development and improvement of Region Cluster / country Quality systems and metrics
• Timely trending of data and operational key performance indicators
• Provides information to evaluate Quality Management Reviews for the Region;
• Provide feedback and country/regional cluster regulation trends to support the continuous improvement of Shire’s Quality Management Systems
• Ensure that GMP aspects are covered and potential risks identified, investigated and reported to Senior Management.
Accountable for Quality Assurance Operations and Oversight in Region Cluster / Country
• QA oversight of transportation, receipt, sampling, testing, release, distribution, warehouse operations either in house or at contract organizations, in region cluster and country as applicable
• Lead, Review, approve or delegate approval of all GMP/GDP documentation related to Country/Regional Cluster including procedures and documentation for quality assurance, quality control, facilities and engineering and supply chain:
- Applicable SOPs, Specifications
- Applicable OOSs, Deviations, CAPAs, Change Controls
- Applicable QTAs, audit reports, inspection responses, audit responses
- Disposition finished product lots as applicable
- Disposition return, rejected, recalled or falsified goods. Support returns and destruction. Authorize and manage product rework and destruction with the support and approval of GMP groups such as QA and QP.
- Applicable reprocessing and reworking, methods, sampling, testing, stability, validation protocols and reports
- Applicable transportation, storage, shipping validation
- Applicable Annual Product Quality Reviews
- Track and trace
- May review regulatory submissions
• Leading Product Complaints and Recalls and maintains correspondence with all enabling groups at the site and center functions. Interact with Health Authorities related to field actions, in partnership with RA
• Oversight of Regional cluster or country Quality operations of Contract manufacturers, distributors, Business Partners, Contract Testing Laboratories as applicable
- Ensure applicable QTAs are in place
- Audit contract organizations, review/approve responses.
- Maintain authentic working relationships with external suppliers including conducting Quality Review Meetings as applicable
- Manage daily interaction and communication flow with contract organizations related to quality matters.
• GDP inspection management for country/region cluster
- Ensure inspection readiness
- Host inspection following global process. Collaborate with global quality as well as country office personnel.
- Prepare inspection response
- Assuring approved regulatory agency requirements in Regional Cluster or country are implemented in a timely manner;
• Execute Quality related activities for product launches of marketed products.
- Participating in technology and test method transfer (as applicable) and Oversight of process improvement projects ;
- Provide Quality Oversight for technical transfer, Technical Agreements and other issues related to GMP/GDP.
- Provide Quality input into the selection of local contract organizations. Responsible for quality oversight of qualification of new contract organizations.
- Approve launch related change controls and other documentation.
• Oversee quality-related licenses for the local operation, handling of Controlled Substances, physician samples, etc. May act as the Responsible Person for country and or countries in regional cluster
• GMP quality record archival
• Sit on country leadership teams. Develop close relationships with other internal functions e.g. Regulatory Affairs, Global Pharmaceutical Technology, Materials Management, Supplier Relationship Management, Supply Chain, both at a local and global levels. As applicable, work with dotted line reporting RA/QA professionals in country to achieve Quality Assurance results in country.
Education & Experience Requirements:
• University degree or equivalent qualification in Life Science subject
• Strong experience working in Quality Assurance as a Person in Charge performing disposition and distribution of tablets, parenterals (biologics), and devices.
• Interpersonal skills and professional skills to interact with contractors while representing Shire.
• Experience working directly with Contract organizations to resolve significant compliance deficiencies associated with downstream processing of biological products.
• Thorough understanding of quality systems, cGMPs and GDP's.
• Excellent knowledge of local GMP regulations, plus good awareness of other GMP requirements e.g. ICH, FDA
• As applicable and required by local regulations, may need to possess specific degree and/or certification.
• Quality experience in solid oral and parenteral biotech manufacturing (aseptic or sterile processing)
• Experience working with contract manufacturing
• Experience interfacing with regulatory bodies directly and working on regulatory submissions.
• High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor)
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