Our client, a smaller but growing biotech company, is looking for a Manager of Aseptic Quality Operations to join a newly formed team at their brand-new site. Responsibilities of the position include establishing and maintaining quality systems and compliance oversight to ensure the facility, utilities, equipment, and computer systems meet cGMP and company compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Essential Duties and Responsibilities:

• Working across functions, to establish the site’s quality system processes related to GMP compliance of the facility, utilities, equipment, and computer systems.
• Ensure the quality oversight and review of validation and qualification activities for the site is performed including assurance that the appropriate resources, materials, and documentation are utilized, and that work is performed in a compliant and controlled manner.
• Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.

Basic Qualifications and Capabilities:

• Aseptic manufacturing experience with sterile injectables is required.
• Bachelor’s degree in a scientific discipline with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry. Experience in facility, utilities and equipment qualification, computer validation and calibration and maintenance programs.
• Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
• Process, method and cleaning validation.
• Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
• Quality management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.