Program Director of Regulatory Affairs

Job Summary:

This position is responsible for assisting the Director of Regulatory Affairs with oversight of the ClinImmune Cell and Gene Therapy, Histocompatibility, Stem Cell Laboratories and Cord Blood Banks to maintain compliance with regulatory agencies and accrediting organizations, including FDA, CLIA, ASHI, FACT, AATB, AABB, state agencies, NMDP, UNOS, lRB, and CAP.

Key Responsibilities:

* Regulatory & Clinical Laboratory Compliance which includes submissions, and compliance with quality and federal guidelines and reporting.

* Quality Assurance and reporting for the Clinical Lab by working with the Histocompatibility, Cord Blood Banks and Cell and Gene Therapies Laboratory directors, supervisors, and managers to assure efficient reporting and safe, pure, and potent product and testing release.

* Cellular Therapy campus wide quality program by providing review of all quality management programs and interactions with UCH BMT staff, UCH Pharmacy P&T Committee, other entities within the University, as needed for SOC, as well as clinical trial study sponsors external to the University.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 2 -3 days per week on campus and as needed for in-person meetings upon successful training and with approval of management.

Why Join Us:

As an academic based biotechnology company, ClinImmune is committed to providing the highest quality service and support to clinical customers and researchers locally and abroad. Our prime location at the University of Colorado Anschutz Medical Campus allows for collaboration with world-renowned clinicians and scientists. ClinImmune is an academic and clinical component of the University of Colorado Anschutz Medical Campus.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including:

* Medical: Multiple plan options

* Dental: Multiple plan options

* Additional Insurance: Disability, Life, Vision

* Retirement 401(a) Plan: Employer contributes 10% of your gross pay

* Paid Time Off: Accruals over the year

o Vacation Days: 22/year (maximum accrual 352 hours)

o Sick Days: 15/year (unlimited maximum accrual)

o Holiday Days: 10/year

* Tuition Benefit: Employees have access to this benefit on all CU campuses

* ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

* Bachelor's degree in clinical laboratory science, biology, biochemistry, chemistry, or a directly related field from an accredited institution.

* Six (6) years of professional health care or clinical regulatory compliance experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

* Master's degree in business administration, healthcare administration, or a directly related field.

* Experience with cell and gene therapies and HLA.

* Relevant, patient- focused biomedical experience (*equipment not included).

* Certification in quality management (e.g. ASQ or Six Sigma).

* Experience working with an electronic document control system.

* Direct healthcare-related experience.

* Two (2) to four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory.

* MT(ASCP) or MLS certification.

Knowledge, Skills, and Abilities:

* Ability to communicate effectively, both in writing and orally.

* Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

* Outstanding customer service and active listening skills with the ability to recognize and take care of the patients' and clients' needs while following company procedures.

* Proficiency with Microsoft functions.

* Knowledge of human anatomy and medical terminology.

* Essential knowledge of the principles of clinical laboratory testing and quality control as it relates to HLA testing and cellular therapy product processing, labeling, storage, and preparation for infusion.

* Ability to be held accountable or answerable for one's work and conduct.

* Organization skills with the ability to complete work within given deadlines.

* Detail oriented with the ability to prioritize tasks accordingly and perform work accurately and thoroughly.

* Ability to work effectively with a team towards a goal.

* Ability to adapt to changes in the workplace.

* Ability to follow established guidelines, policies, standards, or legislation.

Conditions of Employment:

* To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, with minimal supervision and critical thinking. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address.

Questions should be directed to: Sandra Fradenburg, sandra.fradenburg@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by November 15^th, 2025. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $91,488 - $115,935.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.