Sr. Specialist, External Quality Operations

Job#: 3017172

Job Description:

Title: Sr. Specialist, External Quality Operations

Description of Position:

Our biotech client is seeking a Sr. Specialist in the Quality Assurance (QA) department reporting to the Sr. Director of External Quality Operations. This position will be responsible for ensuring quality of cGMP activities at external contract organizations (CxOs) for aseptically produced investigational cell and gene therapy products. This position will work with a diverse group of internal and external partners.

Responsibilities:

·Lead cGMP QA compliance activities at external CxOs for all relevant operations, including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products

·Oversee quality aspects for technology Transfer, commissioning, qualification and validation activities for equipment, batch record review, deviation handling and quality event processes at external CxOs

·Support complex external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally, when applicable

·Liaise with external QA representatives and maintain external relationships

·Maintain knowledge of current industry standards and trends in best practices for compliance with cGMP regulations

Minimum Requirements:

·Life Sciences-based BSc or advanced degree with a minimum of 5 years’ QA experience in pharma, biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and QA operations in a GMP-regulated environment

·Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy

·Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations

·Ability to support teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts

·Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity

·Experience working with CxOs and contract testing labs preferred

·Ability and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight)

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.