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Manager, Quality Assurance
Morrisville, NC 27560 United States
Foundation Medicine is leading a transformation in cancer care, where each patient's treatment is informed by a deep understanding of the molecular changes that contribute to their disease.
As a molecular information company, we are focused on fundamentally changing the way in which patients with cancer are treated. Our products provide more than information. They offer hope to patients, their families and friends, their physicians and caregivers.
As a member of the Foundation Medicine team you'll work with everyone fighting the disease—patients and their families, payers, physicians, drug developers—to raise awareness about this transformation in cancer care and Foundation Medicine's role to ensure we're delivering the tools and information they need to make an impact and drive access for patients everywhere.
Headquartered in the heart of Cambridge, MA, with an additional testing site located in Research Triangle Park, NC, we offer competitive salaries, generous benefits and with our rapid growth, ample career opportunities.
What makes Foundation Medicine so special?
The cancer treatment paradigm is evolving rapidly and we believe there is now widespread recognition that cancer is a disease of the genome, rather than a disease defined solely by its specific anatomical location in the body. Today, physicians increasingly use precision medicines to target cancers based on the specific genomic alterations driving their growth, but most currently available molecular diagnostic tests only reveal a few of the possible alterations. Foundation Medicine provides truly comprehensive molecular information products that can assess the broadest range of relevant genomic alterations from a patient's tumor and distill this complex molecular information into a concise and actionable format that reveals more treatment options for physicians and their patients.
We've seen the difference that our technology can make in the lives of patients, but there is still enormous potential to help even more people. In our drive to help transform the way in which patients with cancer are treated, we strive to improve every life we touch through our dedication to innovation, our commitment to people, and our passion for performance.
The Quality Assurance department manages all Corporate Quality Systems and Quality Operations functions in addition to providing Quality oversight for continuous improvement activities and the review and approval of technical documents. Staff works closely with subject matter experts to facilitate investigations and ensure business targets are met for all compliance issues. The Quality Assurance team also collaborates with remote site quality departments on the enhancement of systems, workflows, and tools used for Quality Systems management. The RTP Quality Manager is responsible for FMI Quality Operations and will report to Cambridge QA senior management and will have a “dotted Line” accountability to the RTP, VP of Operations. This individual will lead the RTP site in creating a “culture of quality”.
• Responsible for the development and refinement of site quality systems and procedures and for adhering to domestic and international GMP regulations, cGMP's, and company policies.
• Evaluation of Site technical documents to ensure completeness and correctness of supporting Change Control documentation for changes. Serve as the Site QA approver for this supporting documentation.
• Support the Quality Assurance review and approval of all site related CAPA, Deviations/Investigations, batch records, Patient Reports, change controls, computer System Validations, equipment validation, quality engineering, Complaints, Quality Control, Supplier Quality and continuous improvement activities.
• Provide QA support for electronic system integration (i.e. LIMS, E-Docs etc.) into RTP site.
• Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional QA group.
• Lead and coach direct team and drive a high performance organizational culture that accommodates rapid growth and highly dynamic expectations.
• Management of cross-site quality issues and implementation of harmonized cross-site quality philosophy; participate in standardizing quality operations across all FMI sites.
• Assuring appropriate GMP and QA systems training of site personnel.
• Preparing for/ supporting/ leading regulatory inspections and third party audits.
• Providing information for regulatory submissions as necessary.
• Responsible for timely hiring, training and development of qualified staff to ensure effective execution of roles and responsibilities, GMP compliance, and attainment of site operational and development goals.
• Ensuring regular self-inspections are performed.
• Bachelor's degree in Science or Engineering preferred and a minimum of 6 years of experience working in a regulated, cGXP environment, or 10 years' direct industry experience in regulated GXP environment preferred.
• Demonstrated knowledge of cGXP regulations and guidance.
• Experience in CLIA / CAP Lab Quality highly desirable.
• Experience with CAPA.
• Experience with Root Cause Investigations.
• Operations experience in one of the following areas: Quality Assurance, Quality Control, Lab Operations Technical Support, Facilities Engineering, or Automation.
• Experience with root cause analysis tools.
• Demonstrated experience with change control, CAPA and deviation quality systems.
Competencies and Leadership Qualifications:
• Driven. You will be focused on the achievement of major alliance goals.
• Solutions focused. Willing to bring creative problem-solving skills to challenges along the way.
• Scientifically-oriented. You will enjoy learning and being involved in the content of our collaboration activities, and able to converse fluidly with internal and external team members on project goals and activities.
• Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise.
• Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent.
• Ability to communicate clearly and concisely with all stakeholders.
• Business-savvy. You'll be interested in new business development opportunities, being able to bring those to the attention of the right teams at FMI and able to support those activities as requested.
• A proven cross-functional leader. You will have demonstrated the ability to “influence without authority” and achieve objectives across complex projects and organizational structures.
• Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the collaborations.
• Adhere to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Constantly striving to make Foundation Medicine a great place to work, and a company respected for the quality of its people and products.
• Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
About Foundation Medicine
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's initial clinical product, FoundationOne™, is a fully informative genomic profile to identify a patient's individual molecular alterations and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.
Note to Employment Agencies
Foundation Medicine values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Foundation Medicine is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Foundation Medicine who is not a member of the Human Resources team.
Apply Here: http://www.Click2apply.net/6j6v8hj28g7nry9z
North Carolina Biotechnology Center