Job Title: Medical Director (Center Physician)

Location: Toledo, OH (Onsite; limited remote tasks may be permitted)

Job Type: Contract | Full-Time (40 hours/week)

Duration: 12 months (multi year extension option indicated)

About the Role
Seeking a Medical Director to provide medical oversight at a plasma collection center, serve as the primary physician for regulatory reporting, and ensure compliance with FDA, CLIA/COLA, and cGMP standards. Responsibilities include directing Center Medical Staff, overseeing donor suitability and incident reviews, and maintaining high medical and quality standards. Lab Director qualifications are preferred.

Key Responsibilities

• Serve as the primary physician for FDA reporting; monitor medical compliance per Title 21 CFR and applicable state regulations.

• Fulfill or delegate CLIA roles (laboratory director, technical or clinical consultant); ensure CLIA/COLA training, proficiency testing (hematocrit, total protein), and standardization logs are completed.

• Maintain cGMP adherence via collaboration with center management and quality; be onsite for agreed hours.

• Provide medical oversight and training for Medical Staff Associates (MSAs) and physicians; evaluate new MSAs and recommend certification completion.

• Review and sign MSA notebooks weekly; sample-review screening evaluations and unsuitable test result communications.

• Conduct monthly meetings with MSAs; document discussions; participate in weekly meetings with center leadership and the Quality Assurance Team.

• Advise on donor suitability for serial plasmapheresis; conduct confidential donor interviews and respond to eligibility questions.

• Review/sign moderate and severe medical incident reports before donor re-entry; review SPE results and document approvals to resume donating.

• Oversee medical supplies and emergency equipment; ensure confidentiality of donor, employee, and center records.

• Support non RBC immunization and hyper immune programs where applicable, including required evaluations, approvals, and presence during immunizations; provide monthly reports to divisional leadership.

• Perform center physician duties as needed: notify donors of unsuitable results, conduct screening medical evaluations, determine suitability, and explain informed consent.

• Perform additional medically related services as requested.

Required Qualifications

• MD or DO from an accredited medical or osteopathic school.

• Active, unrestricted medical license in Ohio (must be maintained).

• Minimum one year of residency training (MD or DO).

• Knowledge of infectious disease markers (HIV, HBV, HCV, syphilis) and donor health/safety standards.

• Experience in regulated clinical/laboratory settings (FDA, CLIA/COLA, cGMP).

• Strong leadership, documentation, and communication skills; ability to train and mentor clinical staff.

Preferred Qualifications

• Lab Director qualifications preferred.

• Prior experience in plasma/blood collection operations.

• Experience serving in CLIA laboratory leadership/consultant roles.

• Participation in Quality Assurance teams and regulatory audits.

Key Skills
Center Physician Oversight | FDA/CLIA/COLA Compliance | cGMP | Donor Suitability | Medical Staff Training | Incident Review | SPE Result Review | Quality Governance | Confidentiality

Interview & Work Details

• Interview Format: Webcam or in person.

• Schedule: Full time; onsite presence for agreed hours. Limited remote activities may be permitted per policy.

• Notes: Backup CMD coverage for the Toledo center; potential multi year engagement with annual extensions.