Senior Manager, Quality Assurance Operations - REMOTE

Proclinical is seeking to hire a remote Senior Manager, Quality Assurance Operations. This individual will provide quality leadership and oversight of manufacturing organizations using phase appropriate quality systems to ensure the availability of product for the clinical trials and foster strong relationships with external partners.

Job Responsibilities:

• Ensuring products for human use are manufactured in compliance with the applicable requirements, regulations and guidance and meet appropriate quality specifications and standards
• Responsible for the disposition of critical raw materials such as immunogen and cell therapy drug products produced in contract manufacturing operations (CMO).
• Review batch data, including batch records, deviations, in-process data, EM data, stability data, QC release testing and other quality systems as applicable to determine acceptability of product disposition
• Provide QA support of technical transfers including Analytical method transfer, stability program, quality events, risk assessments, change controls, deviations, investigations (OOS, OOT), and CAPAs
• Supports the development and implementation of GMP Quality Systems such as disposition, vendor management, deviations, CAPA, and change controls
• Work collaboratively with internal cross-functional team and CMO to resolve issues during production and testing

Skills and Requirements:

• BS in Chemistry, Pharmacy, Biology or a related life science.
• Minimum of 8 years of experience within the GMP quality function of the pharmaceutical/biotech industry
• Knowledge of cGMP regulations for Phase 1 - 3 clinical trials, ICH and global regulatory guidance
• Direct experience working with CMOs to meet product disposition timelines.
• A strategic thinker that can break down barriers, drive great decisions, and make an impact in a rapidly growing company
• Ability to multi-task and independently prioritize daily workload
• Ability to work in a fast pace environment with less supervision
• Experience with a cell therapy product is preferred
• Must be willing to travel domestically and internationally up to 20%

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@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.

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