Quality Assurance Manager

Quality Assurance Manager - Contract - Gaithersburg, Maryland MD

Proclinical is seeking a dedicated professional to manage and enhance quality processes across international operations in the biotechnology industry.

Primary Responsibilities:

The successful candidate needs to be a dedicated professional in order to manage and enhance quality processes across international operations in the biotechnology industry. The role focuses on leadership, oversight of teams, and establishing collaborative relationships with Contract Manufacturing Organizations (CMOs).

Skills & Requirements:

• Bachelor's degree in Sciences or Engineering.
• Substantial Quality industry experience is a necessity.
• Working knowledge of relevant EU and global GMP regulations and ICH, ISPE standards/guidelines.
• Experience with CMOs, CLOs, vendors, and regulatory inspections is beneficial.
• Knowledge of computerized systems, automation, operations and manufacturing/testing within the biotechnology industry.

The Quality Assurance Manager's responsibilities will be:

• Lead and oversee teams managing CMO sites to ensure adherence to approved policies, regulations, and quality agreements.
• Review and approve cGMP documentation, support quality investigations, manage CAPA for CMO activities, and coordinate approval of all changes made to manufacturing.
• Establish and maintain collaborative relationships with CMOs.
• Oversee timely reporting and closure of Quality events, and proactively monitor the performance of CMOs.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado on a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDCQA