Site Quality Leader - OSD CDMO, Regulatory Excellence

Regulatory Jobs; High Point (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Thermo Fisher Scientific seeks a Site Quality Head for our Oral Solid Dose CDMO facility. You will lead QA initiatives, ensure regulatory compliance, and drive continuous improvement across manufacturing operations, enabling high-quality products and patient safety.

As the independent Quality authority on the Site Leadership Team, you will oversee the Pharmaceutical Quality System, batch disposition, and regulatory inspections, shaping a culture of excellence and client partnership.

Qualifications

• Bachelor's or advanced degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
• 12–15 years of pharmaceutical manufacturing experience with leadership in quality.
• Strong knowledge of OSD manufacturing, cGMP, and regulatory expectations.
• Experience leading regulatory inspections and client audits.

Responsibilities

• Lead quality strategy and regulatory compliance for an Oral Solid Dose CDMO facility.
• Own site Pharmaceutical Quality System and release decisions.
• Represent Quality on the Site Leadership Team and drive continuous improvement.
• Halt manufacturing when quality or compliance risk is identified and support client audits.

Skills

QA leadership

cGMP knowledge

FDA/EMA regulatory

OSD manufacturing

CAPA, change control

risk management

data integrity (ALCOA+)

cross-functional collaboration

Education

Bachelor's or higher in Life Sciences/Engineering/Pharmaceutical Sciences

Tools

Quality Management Software

Job description

Thermo Fisher Scientific seeks a Site Quality Head for our Oral Solid Dose CDMO facility. You will lead QA initiatives, ensure regulatory compliance, and drive continuous improvement across manufacturing operations, enabling high-quality products and patient safety.

As the independent Quality authority on the Site Leadership Team, you will oversee the Pharmaceutical Quality System, batch disposition, and regulatory inspections, shaping a culture of excellence and client partnership.