QA Compliance Consultant

Piper Health & Sciences is actively seeking a QA Compliance Consultant to assist with transitioning and developing a mid-size biotechnology company from clinical stage to commercial readiness. This is a hybrid role based out of Rockville, MD.

Responsibilities for the QA Compliance Consultant include:

Ensure inspection readiness by conducting and leading comprehensive internal audits and assessments to confirm QC laboratories, manufacturing suites, and supply chain areas are in compliance with cGMP and regulatory standards.

Implement and improve data integrity practices and compliance with cGMP guidelines by providing oversight for routine Data Integrity auditing activities.

Foster a culture of quality, continuous improvement, and accountability.

Support supplier/vendor qualifications and audits to ensure compliance.

Assist with producing and reporting on annual product quality reviews (APQR).

Rectify any potential issues by effectively communicating with authorities, analyzing data and manufacturing processes, and implementing process improvements/corrective actions (CAPAs).

Qualifications for the QA Compliance Consultant include:

8+ years of experience in GMP/cGMP quality compliance roles, preferably at a commercial-stage pharmaceutical or biotechnology organization.

Proven expertise leading internal audits for inspection readiness.

Experience performing supplier qualifications and/or annual quality product reviews is preferred.

Minimum of a Bachelors degree in a related field is required.

Compensation for the QA Compliance Consultant includes:

Salary Range: approximately $48.00 - $65.00 hourly, commensurate with experience

Comprehensive Benefits: Cigna Medical, Dental, Vision Insurance, ADP 401k, STD, LTD, PTO, Paid Holidays, Sick leave as required by law

This job is open for applications beginning 2/5/2025. Applications for this role will be accepted at least 30 days from the posting date.

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