The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Come join our team and become part of what the Boston Globe has recognized as one of the Top 100 Women-Led Businesses in Massachusetts 2018, 2019 & 2020!
Saving lives through organ and tissue donation is the mission uniting our employees and drives the work we do.
New England Donor Services (NEDS) coordinates organ and tissue donation in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, the eastern counties of Vermont and Bermuda. Through its federally designated organ procurement organization (OPO), New England Organ Bank (NEOB), and its centralized tissue donation services operation, NEDS serves thousands of donor families each year who have generously made the decision to donate and honor the wishes of those who registered as donors and gave the gift of life.
Responsible for one of the largest of the 57 OPOs that make up the nation’s donation system, NEDS works with about 200 hospitals and serves 14 million people in our region, screening nearly 50,000 potential donor referrals annually. With approximately $90M in operating revenues, NEDS employs 250 clinical and non-clinical staff members throughout New England.
Working sensitively with the donor families, NEDS staff lead donation authorization discussions, maintain medical support of potential donors, coordinate recovery surgeries, allocate organs according to the national transplant waiting list and direct transport of organs to transplant centers and tissues to processors.
Our vision is to be a leader in the development and implementation of strategies to increase the life-saving and life-enhancing gifts of organ and tissue donation through effective relationships with our clinical partners, donor families and the communities we serve.
Come join an incredible team of Quality professionals! Our team utilizes Quality practices and tools to ensure that New England Donor Services complies with all regulatory requirements that are designed to maximize the safety and availability of organs and tissues for transplant. The Manager, Quality Compliance will be primarily responsible for ensuring NEDS’s compliance with internal Standard Operating Procedures (SOPs), accrediting Standards, processor requirements and governmental regulations.
Responsibilities include, but are not limited to:
Collaborates with Quality Management staff to establish and maintain an effective quality assurance program to meet FDA, AATB, EBAA, AOPO, UNOS, CMS and tissue processor requirements.
Serves as Chair of the Audit Committee.
Facilitates and monitors audit schedule, and works with department leadership to implement corrective actions to audit findings.
Conducts internal audits on all tissue banking systems to identify trends or recurring problems in donor evaluation and acceptance, tissue recovery, preservation and packaging, donor testing, quarantining, labeling and storage.
Conducts internal audits on all organ donation systems to identify trends or recurring problems in donor evaluation, organ allocation and acceptance, organ recovery, preservation and processing, organ donor testing, labeling and storage.
Reviews content of learning and training programs to ensure accuracy and compliance of process to requirements and applicable standards.
Hosts inspections by tissue processors, AATB, EBAA and FDA, prepares response and assures corrective actions are developed and implemented as necessary under the direction of the SVP of Quality Systems.
Hosts inspections by CMS, UNOS and AOPO and assures corrective actions are developed and implemented as necessary under the direction of the SVP of Quality Systems.
Collaborates with the Quality Systems team to support performance management, safety monitoring and quality improvement initiatives across NEDS.
KNOWLEDGE, SKILLS AND ABILITIES:
Exhibits enthusiasm toward, and supports others in the achievement of NEDS’ mission in a positive manner.
Demonstrates a high degree of service and support to both external and internal customers.
Represents NEDS and its mission in a positive manner.
Knowledge of and ability to apply Quality tools to identify cause and variance and to drive improvement.
Proficiency in Microsoft Office applications including Excel, SharePoint, VISIO and PowerPoint.
Familiarity with electronic quality management systems.
Ability to influence and support a culture of quality throughout the organization.
Strong organizational skills with attention to detail.
Excellent communication skills and ability to work well with a variety of others.
Ability to multi-task and adapt to changing work priorities.
CTBS required within 1 year of assuming the position.
ASQ Quality Auditor or equivalent within 1 year of assuming the position.
EDUCATION AND EXPERIENCE:
BA/BS Degree required; Master’s Degree preferred
2-4 years’ experience in a quality leadership role
New England Donor Services (NEDS) is seeking experienced, dedicated and enthusiastic people to join our team. Saving and healing lives through organ and tissue donation is the mission uniting our 250 employees and drives the work we do. NEDS has been at the forefront of advances in transplant medicine through our work with 14 of the nation’s leading transplant centers. Come join us and make a difference in the lives of others every day.
When you join New England Donor Services you can expect competitive salaries and a great benefit package. Benefits include a generous Paid Time-off program, BCBS Health Insurance, BCBS Dental Insurance, 2x Annual Salary Life Insurance, Vision Insurance, Pet Insurance, Flexible Spending Account, Short-term Disability Coverage, Long-term Disability Coverage, 403b Retirement Contribution, Tuition Reimbursement, Employee Assistance Program and Discounts through Working Advantage.
New England Donor Services is an equal opportunity employer and encourages diverse candidates to apply to meet the needs of the multicultural and multilingual communities we serve.