Quality Assurance Manager - Remote

This position will direct efforts to harmonize practices across all JAX locations, both domestic and international where applicable, drive organizational change and implement quality improvements. This position will develop and execute JAX-wide strategies to enhance process efficiency, improve risk mitigation, and oversee key quality functions, including internal and external audits, deviation reviews, CAPA facilitation, document control, and change management. Position will be responsible for training and leading the Quality team in industry best practices, and will be responsible for reshaping quality culture across the global organization. The salary range is $85,987 - $130,000. Salary will be determined based on qualifications and experience. The candidate hired into this role will be able to work remotely and travel to external audit sites and JAX locations as needed (10%.) Key Responsibilities (What you contribute): Develop a long-term process development and improvement strategy, focused on assuring quality, and in collaboration with others in the global organization Proactively identify, analyze and leverage quality data to identify trends and risks, manage risk-based assessments and support the implementation of risk mitigation strategies Develop and implement continuous quality improvements in systems to reduce complexity, improve effectiveness, efficiencies and productivity and ensure sustainability and globalization Develop and ensure a high-quality process development and improvement policy is propagated, understood, and implemented organization-wide; provide strategic leadership in a policy setting Determine and implement the quality assurance/quality system subset strategy for global team Co-lead the implementation of quality and regulatory compliance software systems Direct quality personnel by coaching, counseling, and leading employees Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies Other duties as assigned Minimum Qualifications: Bachelor's degree and 7 years of quality related experience. At least 2 years of supervisory experience. Lean/Six Sigma Certification preferred. Quality certifications (CQA, CQM/OE, etc.) a plus. Functional management/leadership experience in a pharmaceutical or biotechnology operation. Experience with and knowledge with ISO 9,001 standards. Expertise in supplier qualification and supplier quality management. Experience with CAPA processes, systems, root cause analysis and quality metrics. Skilled in audit execution and report writing. Research regulatory compliance experience preferred. Grows relationships with key organizational influencers and customers by building credibility and trust. Experience with change management in multi-site, complex environment. Advanced interpersonal skills sufficient for developing complex, dynamic relationships with a diverse variety of individuals representing a broad cross-section of cultures, disciplines, and levels of sophistication. Advanced verbal and written skills sufficient to communicate with the senior leaders in a variety of partner institutions. Ability to formulate, analyze and evaluate complex plans and programs. Ability to keep current on industry practices, regulatory requirements and industry changes. Champion of Lean and continuous improvement. Ability to travel, 10%. #CA-DS5 About JAX: The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California), Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health. Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org. EEO Statement: The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws. Bar Harbor: The Jackson Laboratory's 43-acre scenic Bar Harbor campus is nestled between the Gulf of Maine and the mountains of Acadia National Park. Some of the best hiking and biking in the world (over 50 square miles of mountains, lakes, views, and dramatic coastline) is accessible from our campus. We are one mile from downtown Bar Harbor, which offers a vibrant downtown district with a plethora of restaurants, shops, museums, and galleries. Ellsworth: The Charles E. Hewett Center in Ellsworth, Maine, is a state-of-the-art facility that serves researchers world wide. The facility represents the culmination of nine decades of unmatched experience and leadership in breeding and caring for laboratory mice. Ellsworth, Maine, is one of Maine’s fastest growing cities. With a growth rate of nearly 20%, Ellsworth is a bustling year-round community and acts as a hub for surrounding towns. It is located nearby Acadia National Park and hosts numerous special events, concerts and festivals each year. Residents have access to fabulous shopping, recreation, museums, galleries, and dining at a variety of independent restaurants. Farmington: JAX Genomic Medicine is transforming medicine by improving patient care, lowering costs, and increasing life span and health span. JAX Genomic Medicine’s research focuses on the complex genetic causes of disease and on the development of genomic solutions tailored to each person's unique genetic makeup. JAX Genomic Medicine sits on a 17-acre site on the campus of the University of Connecticut Health Center. The 183,500-square-foot facility opened in the fall of 2014. Now, it houses over 300 biomedical researchers, technicians, and support staff in state-of-the-art computing facilities and laboratories. In Connecticut, JAX resides in the scenic town of Farmington, in the state’s capitol region. The Hartford region, which offers some of the best public schools in the country, is made up of both bigger cities and smaller, charming historic New England towns. JAX Genomic Medicine is also geographically located within 2 hours of Boston and New York and is close to multiple transportation systems, including bus lines, highways, railroads and international airports. Sacramento: The JAX® Mice, Clinical and Research Services facility is located in Sacramento, the state capital of California. Sacramento is less than a two-hour drive from San Francisco, Napa Valley, and scenic Lake Tahoe, and a short flight to both Los Angeles and Orange County. Sacramento is the birthplace of the nation’s Farm to Fork movement, and offers excellent restaurants, gastro-pubs, wineries, theaters, and museums. Outdoor activities are plentiful: Boating, white water rafting, and riding the scenic bicycle trails are popular. Housing and other costs of living are more affordable in Sacramento and its surrounding suburbs than in most other neighboring areas in the North Bay, making Sacramento one of the hottest housing markets in the country year after year. Augusta: JAX’s Maine Cancer Genomics Initiative (MCGI) is located in Augusta, Maine, in the Harold Alfond Center for Cancer Care (HACCC), at Maine General Hospital. It began operations in 2016 with three overarching goals: to provide cancer genomic testing for Maine cancer patients; to develop and deliver physician education about clinical genomic cancer diagnostics; and to build a network in Maine of oncology practices conducting studies in genomic medicine.

Salary : $85,987 - $130,000