Quality Director

We are committed to the diversity of our workforce and to delivering our programs and services in a culturally competent manner reflecting the communities we serve. Our work environment is collaborative, respectful, and inclusive with a focus on building allyship and a culture of belonging that empowers all team members. Come to learn, grow, and succeed while sharing your passion for making a difference.

The Red Cross supports a variety of cultural and community resource groups for employees and volunteers. From the Ability Network, our Asian American & Pacific Islander Resource Group, the Latino Resource Group, and Red Cross PRIDE, tothe Umoja African American Resource Group, our Veterans+ Resource Group, and the Women's Resource Group, these networks provide connections, mentoring and help give voice to important concerns and opinions.

At the American Red Cross, your uniqueness can shine!

OUR IDEAL CANDIDATE WILL:

Oversee quality functions to include the review, assessment and monitoring activities for records, processes, and systems ensuring adherence to and compliance with policies, practices, and relevant federal, state, and other applicable regulations. Responsible for the full scope of quality inspections, audits, issues and/or operational performance related to compliance and quality. Accountable for strategic quality planning, the development and implementation of continuous process improvements activities, corrective and preventive action programs, trials and/or standardization initiatives. Work collaboratively with facility and functional staff in a diplomatic, professional, tactful way to achieve quality objectives and results while maintaining confidentiality of sensitive information. Provide support, development and/or leadership guidance to all volunteers.

WHERE YOUR CAREER IS A FORCE GOOD:

Key Responsibilities:

• Direct quality functions, activities, processes, and/or systems. Oversee development and implementation of standards, methods, and procedures for inspecting, testing, auditing, investigating, and evaluating the precision, accuracy, and reliability of company products. Identify, evaluate, and recommend strategic changes to business processes and implement corrective actions as needed.

• Work collaboratively with staff at all levels of the organization to ensure that all regulatory requirements are met, processes operate in a state of control and compliance and continuous improvement is a top priority within their area of control.

• Hire, mentor and develop managers and staff and educates staff on quality principles and regulatory requirements.

• Oversee, prepare for, host, facilitate and close out internal and external inspections/audits and coordinates the response and corrective actions to observations. Communicate and report on compliance status of the facility/function to include appropriate quality indicators, audit/inspection results, problem management data and other critical information. May conduct special audits focused on root cause analysis, determining effectiveness of corrective actions and investigations directed by leadership.

• Manage receipt of directives, regulations and reports and other relevant communications from regulatory agencies and ensure distribution and appropriate action is taken by affected departments and staff.

• Oversee the stop of the manufacture, testing and/or distribution of products/services should it be determined that the safety, purity, quality, identify and/or potency of the product or process has been compromised. Ensure appropriate action is taken.

• May serve as SME and quality representative on committees and/or trials.

WHAT YOU NEED TO SUCCEED:

Education: Bachelor's degree required.
Experience: Minimum 7 years of related experience or equivalent combination of education and related experience required. Preferable experience in quality assurance practices/principles in a regulated environment.
Management Experience: 5 years of supervisory or management experience.
Skills & Abilities: Knowledge of federal regulatory requirements and quality assurance practices/principles related to medical industry manufacturing operations. Demonstrated experience in systems and auditing/investigation practices and the ability to analyze technical knowledge and apply judgment to ensure decisions are defensible from a scientific and regulatory perspective while being in the best possible interests of the larger organization. Must display tact, diplomatic and professionalism in difficult situations. Must protect the confidentiality of sensitive information in the department. Ability to work on a team.
Travel: Ability to travel up to 50%.

*Combination of candidate's education and general experience satisfies requirements so long as the total years equate to description's minimum education and general experience years combined (Management experience cannot be substituted).

BENEFITS FOR YOU:

We take care of you, while you take care of others. As a mission-based organization, we believe our team needs great support to do great work. Our comprehensive benefits help you in balancing home and work. With our resources and perks, you have amazing possibilities at the American Red Cross to advance and learn.

• Medical, Dental Vision plans

• Health Spending Accounts & Flexible Spending Accounts

• PTO + Holidays

• 401K with 5% match

• Paid Family Leave

• Employee Assistance

• Disability and Insurance: Short + Long Term

• Service Awards and recognition