US National – Telecommute
QA Strategy and Operations Consultant
Job Location: Remote
ABOUT FOUNDATION MEDICINE:
Foundation Medicine, Inc. (FMI) began with an idea?to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
ABOUT THE JOB:
The Quality Assurance Strategy and Operations Consultant utilizes their advanced knowledge and experience in assessments and recommendations on best practices to improve quality functions, formalized procedures, operations and systems. The consultant addresses the above responsibilities in two phases which are ordered by business priority.
Phase I ? Strategic Consulting
Examine at all levels across the organization our current state of quality structure in organization and business processes, and document what gaps may exist.
Assess overarching Quality Structure, Process and Ways of Working, and Standard Operating Procedures (SOPs).
Assess business-function specific quality assurance, with a focus on SOPs and how best to imbed quality into our business, particularly within the following areas:
Research and Development
Provide consulting on strategy and operations as part of Business Process Review, specifically addressing Corrective and Preventative Action (CAPA) and Standard Operating Procedures (SOPs).
Review AZD, Roche and Merck Audit outputs.
Conduct assessments of area and department specific CAPA and remediation plans.
Provide recommendations to update existing structures, ways of working, and method of addressing business gaps.
Provide general recommendations to optimize best quality assurance practices.
Complete above recommendations through presentations to stakeholders; through highlighting, commenting upon or writing new versions of pre-existing documentation; by generating reports; citing best business practices, and other methods as necessary.
Phase II ? Operational Consulting
Operationalize IQVIA GCP.
Complete Clinical Operations Gap Assessment by creating a remediation plan which includes defining the organizational structure, required processes, procedure owners, and standard operating procedures.
Write standard operating procedures as necessary.
Other duties as assigned.
10 years of experience in the pharmaceutical, biotechnology, or diagnostic industries, at least 2 of which including direct Quality Assurance experience.
Experience with managing Quality Assurance activities across multiple quality system regulations and operating under FDA CFR Part 820, ISO 13485 and CLIA/CAP requirements.
Familiarity with Companion Diagnostics.
Scientific background in molecular biology and/or Next Generation Sequencing.
Strong history of achievement.
Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues.
Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow independently without significant day-to-day oversight.
Demonstrated ability of meeting project deadlines.
Understanding of HIPAA and importance of privacy of patient data.
Ability to work well under pressure while maintaining a professional demeanor.
Excellent organization and attention to detail.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employ…
Consulting , Healthcare Consultant , Operations , Medical & Health