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 Bachelor’s 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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