Title: QA Operations Manager

　　Location: Onsite, Philadelphia PA

　　Schedule: M-F 8am-5pm

　　Type: Direct/Permanent

　　Compensation: Competitive salary with an excellent benefits package

　　Start date: Immediate

　　Overview:

　　Join our dynamic team as a QA Operations Manager for a Contract Development and Manufacturing Organization (CDMO) you will play a key role to ensure quality processes, improvement and requirements are met for products developed and produced.

　　Responsibilities:

　　Responsible for the establishment and implementation of QA Operations activities and governing procedures

　　Responsible for compliant, thorough, and accurate batch review activities, including QC analytical data and other ancillary batch documentation.

　　Perform batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigation

　　Manage the QA communication and lot disposition process with CDMO client base.

　　Ensures proper training and qualification of all quality assurance associates in team.

　　Manage QA resources “on the floor” in each of the areas to perform the QA function and provide real-time and direct review, approval, or feedback for the operations.

　　Review and approve documentation generated, including master batch records, specifications, protocols, and report

　　Create, review and approve product specifications, certificates of analysis, and stability protocols/reports.

　　Oversees material and product label printing and ensuring regulatory requirements are being met.

　　Ensures that critical materials used in the manufacture of cellular immunotherapies and gene therapies, are sourced appropriately, received and tested according to approved standards, and provides the disposition of these materials. Supports the vendor qualification program through audits, training, and provides SME where necessary.

　　Provides QA oversight of shipping and receipt of critical materials or final product.

　　Monitoring of process and product related Key Quality Indicators

　　Verifies data integrity across the operations units.

　　Participates and supports internal, client and regulatory audits to ensure compliance to all relevant policies and procedures as required

　　Provides quality in-put into product- or process-related deviations, change control, audits/inspections.

　　Ensure consistency of quality related processes and procedures within the Operations Units.

　　Performs other job functions as directed by the Head of QA.

　　Requirements:

　　BS in Life Sciences, pharmacy, or equivalent; advanced Life Sciences Degree preferred

　　5+ years of experience in Quality Assurance with demonstrated leadership skills, and a strong focus in GMP Quality

　　Proficiency with interpreting and implementing GXPs, FDA, EMA, ISO and ICH regulations and guidelines

　　Experience with Preclinical to commercial product development and experience in biologics preferred

　　Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors

　　Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making

　　Strong technical writing skills (must be able to write investigations and SOP’s)

　　Prior experience with batch record review and releasing batches

　　Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with clients

　　Thrive in a fast-paced, innovative environment remaining flexible, proactive, resourceful, and efficient

　　#M3

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.