Medical Director (Center Physician)

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.