Quality Assurance Manager

Camris•Silver Spring, MD

3d•Onsite

About The Position

We are seeking a Quality Assurance Manager to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Requirements

Must have a BS/BA degree in biology or a related field and 12 years of experience at a biotechnology, pharmaceutical, or related facility, or an equivalent combination of credentials and experience.
Experience in phase 1 manufacturing (preferably vaccine production, mRNA, and monoclonal antibodies).
Requires a minimum of at least four years of experience in QA management/supervision in the areas of documentation control, raw material management, instrument calibration, validation, repair, facility system controls, internal and external audit competency, and compliance training expertise.
Must have experience with FDA GMP facility oversight (preferred: design and startup experience, clinical phase manufacturing, and Annex 1).
Demonstrated experience working with external stakeholders, quality technical agreements (QTAs), and quality aspects of subcontractor oversight.
Knowledge of applicable highly complex office procedures and techniques relating to the position.
Must be able to work independently following a brief period of specific technical training.

Nice To Haves

design and startup experience
clinical phase manufacturing
Annex 1

Responsibilities

Manages QA at the WRAIR Pilot Bioproduction Facility (PBF) overseeing Good Manufacturing Practices (cGMP) compliance, release, policies, and training.
Guides PBF in advancement and implementation of current and project relevant compliance initiatives related to expansion of capabilities, multi-platform manufacturing, and expansion of capabilities such as monoclonal antibody and mRNA GMP production.
Interfaces directly with PBF clients, WRAIR Quality and other QA counterparts representing both WRAIR PBF and CAMRIS.
Leads audit preparation, audit responses and tracking of outstanding compliance initiatives.
Oversees and leads broad Quality Assurance responsibilities, including the inventory of in-process and final released products, raw material control, staff qualification and training, document origination and control, and facilities and equipment validation and maintenance.
Implements the following cGMP systems: personnel training, product deviations, failure investigations, critical change controls, corrective actions, internal and external auditing, and others as needed.
Establishes, leads, and implements risk-based compliance approaches.
Reviews, revises, and/or approves documents: IOQ documents, batch production records, and standard operating procedures.
Dispositions drug substance and drug product produced at PBF to be released for clinical testing (final signatory authority).
Supplies, leads, and generates briefs, as needed, on all matters of QA including the Quarterly Management Review.
Supervises and manages the site quality team.
Provides technical assistance to CAMRIS headquarters as needed and participates in proposal writing projects when requested.
Maintain a safe workplace, ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
The employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs other duties as assigned.