Location:
Seattle Area, WA
Posted Date:
5/17/2012
Position Type:
BS FULL TIME
Job Code:
QA-Mgr
Salary:
Competitive
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Description
THE COMPANY
• Small successful pharmaceutical focused on drug development and commercialization.
• It is also developing a unique drug delivery technology for optimizing patient compliance.
• It has successfully gotten products approved and into the market; in so doing, it has generated significant revenue to both grow its pipeline and maintain a healthy cash position.
• Headquartered in one of the most beautiful cities in North America.
• Why Join: To contribute much-valued skills; to work within a highly collaborative and supportive environment; and to be part of the company’s continued success in achieving its scientific and business goals.
THE POSITION
• The QA Manager (for GLP Systems, Audits, & Supervision) will bring expertise in FDA/GLP and OECD quality standards and to lead us in maintaining superior quality standards while pursuing vigorous preclinical development objectives. The objective is to be FDA audit-ready and inspection-ready at all times, and to maintain optimal GLP standards.
• As the in-house expert and leader of GLP will identify and resolve GLP issues, create new GLP quality systems for GLP processes or improve existing ones.
• Will ensure that clear policies, protocols, and standards are designed, communicated, and implemented- throughout the organization and its affiliates.
• Will have oversight and or conduct regular audits and inspections to monitor company testing sites and facilities to ensure that all activities, instrumentation, facilities, documentation, etc. are GLP compliant.
• Will manage audits or inspections conducted by FDA or other regulatory authorities; will be company QA representative interacting with these respective agency representatives.
• Will coordinate and direct the work of QA team members involved in GLP inspections and record keeping including training, coaching and mentoring.
• As in-house expert, educator, and director or GLP quality assurance, will maintain up-to-date knowledge of all GLP and OECD requirements.
• Conduct ongoing education, training, and coaching on GLP quality assurance of to maintain optimal awareness and compliance among QA and non-QA personnel; will build relationships among QA and non-QA personnel and be available to answer questions, provide insights and problem-solve issues in order to promote a solid understanding of GLP as well as compliance of GLP.
• Apply exceptional interpersonal and influence-management skills while regularly interacting with variety of scientific and technical staff to increase GLP knowledge and awareness and to build collaborative and mutually supportive relationships.
Requirements
QUALIFICATIONS
• BSc degree in a relevant scientific or technical discipline.
• At least 7 years of quality assurance experience within a drug development company.
• At least 4 years in a GLP leadership role that includes oversight of GLP QA facilities and processes.
• Experience conducting GLP QA audits and inspections as well as managing GLP audits and inspections conducted by FDA or other regulatory.
• Advanced knowledge of GLP and OECD and advanced skills and experience creating new quality systems improving existing quality systems for GLP optimization.
• A work history that reflects initiative, planning, and proactive problem-solving skills.
• Proven ability to communicate and interact effectively with a wide spectrum of internal and external staff from various scientific and technical disciplines; includes proven exceptional interpersonal and influence-management skills, ability to increase company-wide GLP knowledge and awareness and to build collaborative, mutually supportive relationships.
KEY MUST HAVES:
• Supervisory leadership experience in QA management.
• GLP operations management experience.
• Creative approaches to diverse QA issues and challenges.
• Willingness to relocate to the Pacific Northwest.
• FDA investigator interaction experience.
• Quality system design and optimization experience.
HOW TO APPLY
1.) Use the link below.
2.) OR, for a quicker review of your qualifications, APPLY DIRECTLY by forwarding your CV---which must be in a WORD-doc. format---to info@biotecher.com using the following (exact) Subject Line: QA-Mgr
EOE
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