Quality Assurance & Compliance Manager

Job Summary

Quality Assurance & Compliance Manager

Relocation Assistance Available for this Role
Minimal travel required up to 25% throughout the U.S. including Puerto Rico.

• Position will be located in Frederick, MD
• GMP Cleaning Experience Required

Essential Responsibilities:

• Job requirement is to be onsite with occasional remote work.
• Lead training for GDP, GMP cleaning, and logbook management (electronic and paper)
• Expectation is to have specific site ownership of cGMP Cleaning Quality programs and expand to multi-site responsibility for Quality and Compliance system management.
• Deploy Regional Quality initiatives across the portfolio of sites: conduct gap assessments as needed and provide key input into the development of such initiatives.
• Oversee and ensure the proper execution of key cGMP quality system elements at a Pharmaceutical Manufacturing site such as records management, document control, change management, CAPA, regulatory and notified body audits, internal audits, supplier audits, training, regulatory management, management review etc.
• Develop continuous improvement programs
• Conduct regular audits and establish processes to improve logbook reviews for exceptions and deviations.
• Develop and maintain Quality Manual for sustained success.

Minimal travel required up to 25% throughout the U.S. including Puerto Rico.

Requirements:

• Experience communicating to peers, hourly associates, and senior management regarding quality, compliance and training.
• Quality Compliance Experience Required
• High school diploma or GED Required
• CGMP Cleaning Compliance Experience Required
• Bilingual in English/Spanish Preferred
• Experienced with writing policies and procedures
• 3-5+ years of related experience in biotech/pharma manufacturing & distribution or other manufacturing environment required.
• 2-year Associate degree (or professional training) in Business Administration, Information System, Engineering , Computer Science, or related fields preferred but not required.