Associate, Quality Assurance (GCP)

LOCATION Research Triangle Park JOB TYPE Full Time, Employee CAREER LEVEL Experienced (Non-Manager) CATEGORY Quality Assurance/Safety RELEVANT WORK EXPERIENCE 5+ to 7 Years REFERENCE CODE 08-0145 Stiefel Laboratories is the world's largest privately held pharmaceutical company, committed to dermatology. For over 150 years, in over 100 countries around the world, Stiefel has been known as family-owned and geared towards innovative skin care products. Stiefel is currently headquartered in Coral Gables, Florida and completed the acquisition of Connetics, in January 2007. This strategic combination grew the company's employee base to approximately 4500. This strategic move further strengthened Stiefel's product line as being one of the most diverse within dermatology. The Stiefel's products treat a variety of dermatological ailments that include acne, psoriasis, fungal infections, and hyper-pigmentation. The company's top prescribed products are Duac and Brevoxyl acne medications, and Polytar dandruff shampoo. In addition, there are consumer products that include over-the-counter remedies as fungal infection treatment Zeasorb, Sarna Lotion for itchy and dry skin, and DermaVite dietary supplements. In June of 2007, Stiefel newly launched REVALÉSKIN™. The launch of REVALÉSKIN™ marks Stiefel's entrance into the highly competitive Cosmetic Dermatology market. This new aesthetic line also represents the company's first market entry as a true global brand. For more information, please log onto our company website at www.stiefel.com Associate, Quality Assurance (GCP) Applications submitted by recruiters and staffing agencies will not be considered,  Thank you for your cooperation. JOB SUMMARY:?  Ensuring quality awareness throughout Stiefel Laboratories R&D.?  Ensuring delivery of Stiefel Laboratories? R&D Audit Program.?  Providing QA support for Clinical and Pharmacovigilance (GPvP) functions ?  Act as QA Project Lead on R&D Project teams or SMT teams. ESSENTIAL DUTIES AND RESPONSIBILITIES:?  Performing audits - Investigator sites, CRO?s, Vendors, Data management, Protocols, Clinical Study reports, internal systems, mock inspections to meet Regulatory requirements ?  Assessment and guidance on non-compliance and quality issues?  Ensuring compliance of the quality documentation related to Stiefel procedures.?  Assist with hosting/managing Regulatory Inspections?  Preparing new and revising existing Standard Operating Procedures (SOPs) owned by Quality Assurance.?  Review of SOPs written by other teams.?  Maintaining a good working knowledge of the current regulatory requirements, corporate standards and local laws and ensuring this is disseminated throughout the company.?  Represent a Quality Image of Stiefel Laboratories R & D?  Advance awareness of GCP and GPvP  requirements within Stiefel ?  Provide training where required on GCP or GPvP ?  Review and approval Quality System Documents relating to GCP or GPvP Deviations, Change Control, Quality Alerts,  CAPA?s,  Specifications, reports for Stiefel Laboratories R& D  QA Project/SMT Lead?  Responsibility for overall compliance of projects with Stiefel Laboratories R&D QA policies and procedures.?  Maintain QA project plan, identifying timescales and critical QA activities.?  Identify GXP vendors requiring audit and incorporate in QA project plan.?  Provide support to other project team functions, e.g. Clinical Operations, Regulatory Affairs, Pharmaceutical Sciences on GXP issues. Requirements: QUALIFICATIONS AND EXPERIENCE:?  Minimum BSc or MSc ?  3 years GCP/GPvP QA and Auditing experience in R&D Clinical and or GPvP environment for pharmaceuticals, biotechnology and/or devices. ?  Ideally 5-8 years experience in Clinical or Pharmacovigilance research experience. ?  Development of products and Clinical research and Pharmacovigilance actives in a global environment?  Full knowledge of Phase I-IV studies?  Ability to travel 40% Applications submitted by recruiters and staffing agencies will not be considered,  Thank you for your cooperation. Apply Now!