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Senior Counsel
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Senior Counsel : GlaxoSmithKline
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| Job Number |
54398 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Rixensart - Wavre (Belgium)
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
6/15/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Legal |
| Relocation |
Not Required |
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| Apply online at company website |
| Description |
Basic Qualification
Legal training JD or Masters in Law (or equivalent) required with 6-10 years relevant legal experience. For US trained lawyers the admission to a national (or local) bar required. Familiarity with biologicals and vaccines industry is strongly preferred. Alternatively, demonstrated experience within the pharmaceutical industry supporting manufacturing operations is acceptable.
Strong preference for broad cGMP and regulatory compliance experience in manufacturing and supply operations with a global vaccines / biologicals company (pharmaceuticals acceptable). Demonstrated ability to advise with respect to with EU and US laws, regulations and guidance applicable to cGMP compliance and Quality Unit operations. Strong preference for demonstrated experience advising with respect to the management of regulatory inspections of manufacturing (and related) operations, development / implementation of corrective action plans, deviation management, complaints and preparation of post-inspection responses to relevant agencies.
Familiarity with EU commercial / transactional experience in support of global manufacturing and procurement functions is desirable.
The individual is expected to be autonomous, resilient and persuasive whilst being able to operate in a complex matrix structure. Excellent writing and communication skills required. Ability to work independently, assemble client resources, meet tight deadlines and work effectively in a multi-functional, international team environment required in particular with technical and scientific people. Ability to manage external legal counsel within specified budgetary limits required. Must communicate effectively with senior Quality Unit staff; senior manufacturing and business management and senior legal staff within Biologicals and GMS. Familiarity with computer technology and electronic communications required. Occasional travel will be required.
Working knowledge of French is desirable but is not a must
Details
GSK Biologicals has a global network of manufacturing operations headed by Patrick Florent (GIO). This network consists of a highly complex supply chain and manufacturing processes which are regulated by various authorities across the globe. The network is expanding rapidly in the Emerging Markets (mainly through acquisitions and JVs) as well as further investments in Europe, North America and Singapore. In addition to the operations, GSK BIO has a quality organization (GQA) within its network which is in charge of safeguarding quality at various steps of the manufacturing operations, conduct audits and prepare and follow up on inspections by the Corporate Audit Functions (ARM) and the Regulatory Authorities.
Due to the growing importance of GSK BIO, the critical mass of its manufacturing operations and the increased regulatory scrutiny, GSK BIO and GSK Legal have decided to create a new job (Senior Counsel) which will report into the GSK Biologicals Legal Department.
GSK BIO is in the process of establishing a Quality Council which will require the presence of a Senior Counsel. As the head of GQA in GSK BIO is a member of the Global Quality Council of GSK and because ARM is supported by GMS Legal, the Senior Counsel will work closely with GMS Legal.
Details. Serve as the primary legal resource to Biologicals Global Industrial Operations (Bio GIO) with respect to day-to-day operations requiring legal support. Principal responsibility for providing advice to Bio GIO related to cGMP and regulatory compliance, Quality Unit operations, manufacturing, distribution activities. In collaboration with other internal and external legal resources, will have lead responsibility for legal support for regulatory inspection management and subsequent agency communications. Provide training and education to Bio GIO clients on legal issues related to cGMP and regulatory compliance matters.
Additionally, will negotiate, draft and review contracts between Bio and third parties pertaining to supply, raw material, facilities services, warehouse / distribution, capital / construction, utilities, site sale and other manufacturing-related agreements. Provide advice to other lawyers in the Bio and GSK Law Department concerning cGMP compliance, manufacturing and procurement-related issues arising in general commercial and other transactions. In consultation with other GSK Legal groups, develop standard form contracts, contracting processes, and policies on legal issues affecting Bio GIO manufacturing operations and procurement activities. Work closely with GSK GMS Legal group through the Global Quality Council and attend best practices meetings at the Centres of Excellence and ad hoc meetings within GMS Legal. |
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| Requirements |
Preferred Qualification
Legal training JD or Masters in Law (or equivalent) required with 6-10 years relevant legal experience. For US trained lawyers the admission to a national (or local) bar required. Familiarity with biologicals and vaccines industry is strongly preferred. Alternatively, demonstrated experience within the pharmaceutical industry supporting manufacturing operations is acceptable.
Strong preference for broad cGMP and regulatory compliance experience in manufacturing and supply operations with a global vaccines / biologicals company (pharmaceuticals acceptable). Demonstrated ability to advise with respect to with EU and US laws, regulations and guidance applicable to cGMP compliance and Quality Unit operations. Strong preference for demonstrated experience advising with respect to the management of regulatory inspections of manufacturing (and related) operations, development / implementation of corrective action plans, deviation management, complaints and preparation of post-inspection responses to relevant agencies.
Familiarity with EU commercial / transactional experience in support of global manufacturing and procurement functions is desirable.
The individual is expected to be autonomous, resilient and persuasive whilst being able to operate in a complex matrix structure. Excellent writing and communication skills required. Ability to work independently, assemble client resources, meet tight deadlines and work effectively in a multi-functional, international team environment required in particular with technical and scientific people. Ability to manage external legal counsel within specified budgetary limits required. Must communicate effectively with senior Quality Unit staff; senior manufacturing and business management and senior legal staff within Biologicals and GMS. Familiarity with computer technology and electronic communications required. Occasional travel will be required.
Working knowledge of French is desirable but is not a must |
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