QA Director

The Sparx Group is an emerging biotech powerhouse best known for its multi-specific antibody and antibody drug conjugate (ADC) discovery platforms. With a mission to “Recover  Human Immunity by Empowered Antibody Therapies”, Sparx has leveraged  artificial intelligence to drive its proprietary target mining engine, allowing identification of cellular targets which can best be leveraged for optimal and synergistic biological activity. This sophisticated target discovery platform is combined with an integrated multi-component SAILING™ antibody optimization system and four cutting-edge ADC technologies to markedly improve the success rate of empowered antibody drug development. In addition to the integrated antibody discovery platform, Sparx has built in-house GMP facilities of significant capacity in both Chicago and China to produce clinical and commercial drug products, allowing its evolution into an integrated and independent biopharmaceutical company.

Sparx is currently looking to fill the role of QA director.  The candidate selected  for this QA role will work in the north suburb of Chicago, overseeing the Quality Assurance activities at Sparx’s Mount Prospect biologics manufacturing facility. Responsibilities include, but are not limited to:

• Developing quality assurance goals, including: prioritization, resourcing, and selection of QA staff to support Biologic development. 
• Implementing and improving the quality management system (QMS) to meet regulatory requirements for product quality and GMP production of drug product used in pre-clinical and clinical studies. 
• Creates and implements the product quality documentation system by writing and revising quality assurance procedures.
• Maintains product quality by enforcing quality assurance policies and procedures consistent with  government regulatory requirements.
• Reviews and approves all related quality documents, including, but not limit to, quality procedures, production batch records, SOPs, validation protocols, QC testing methods, facility qualification and maintenance, etc. 
• Develops and refines specifications for raw materials, excipients and consumables by evaluating manufacturing and engineering requirements, and devising testing methods and procedures.
• Leads, manages and coordinates with cross-functional groups for quality management procedures, such as investigation of deviations, CAPA, risk assessment, etc. 
• Establishes and implements internal and external audits, qualification programs for GMP production, in-process control, facility commissioning, and vendor qualification, etc.
• Establishes standards and specifications for the disposition and release of materials, intermediate and finished product, by devising evaluation tests, methods, and procedures.
• Collaborates with other members of management to develop new product, engineering designs, manufacturing and training programs.
• Conducts periodical quality review and prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Conducts regular GMP audits of both the internal and external GMP production facilities to assure the sites are meeting the appropriate regulatory guidelines/requirements.
• Establishes and executes an effective employee training program, such as OJT program.
• Available to provide ‘on the floor’ guidance and answer questions regarding all aspects of the manufacture of biologic drug products.

Qualifications/Skills:

• Bachelor degree in relevant scientific discipline (biology, biotech, pharmaceutical or biochemistry) with at least 10 years of quality management experience in a regulated Biologics pharmaceutical manufacturing environment.
• Master degree in a related discipline with at least 7 years of quality assurance management experience in biologic drug manufacturing.
• Must have a minimum of 5 years biopharmaceutical industry experience in QMS at a managerial level. Experience with biologics is preferrable, and previous GMP production experience is a plus.
• A comprehensive understanding of GMP, FDA, and ICH/VICH regulations for Biologics manufacturing.
• Knowledge and experience with CMC and regulatory filings, such as IND, BLA and NDA, etc.
• Experience with QA measuring and testing equipment and methodologies.
• Experience with MS Word, Excel, Project Management and Analytics software.
• Strong written and verbal communication skills with efficient documentation skills.
• Effective collaboration skills with a teamwork-oriented mindset, excellent problem-solving, presentation and interpersonal skills with strong leadership abilities.
• Excellent business ethics and professionalism.

Preferred Qualifications:

• Prior leadership experience in quality assurance aspects of biologics drug manufacturing.
• Extensive knowledge of global GxP and regulatory requirements as related to the drug development process. GCP knowledge a plus.
• Flexible and able to adapt to company growth and evolving responsibilities.
• Possess strategic and working knowledge of the biologic product life cycle from pre-IND through BLA, including experience with process and method validation and strategies.
• Experience with Phase 1-3 clinical trial material strongly preferred
• Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, communicating one on one or with larger groups, influencing external partners). Ability to independently problem-solve and make recommendations for solutions.

About SparX Group

SparX Biopharmaceutical Corp. is a research-based development-stage biopharmaceutical company, dedicated to the mission of “strengthening human immunity using robust antibody therapies” through the discovery and development of innovative immuno-oncology agents. Equipped with big data analytical techniques, such as machine learning algorithms, SparX extracts potential interactions from large volumes of complex multi-dimensional public information. Mechanistic pharmacological analyses coupled with in vitro and in vivo evaluations using the syngeneic, transgenic and humanized mouse models, enables SparX’s focus on developing novel or best-in-class therapeutics demonstrating substantial advantages over existing therapies. 

Target discovery and validation has historically been the bottleneck in drug development.  SparX combines its sophisticated target discovery platform with an integrated multi-component SAILING™ antibody optimization system and a cutting-edge bi-ADC technology to markedly improve the success rate of empowered antibody drug development. In addition to the integrated antibody discovery platform, SparX has built in-house cGMP facilities of significant capacity to produce clinical and commercial drug products, facilitating its evolution into an integrated and independent biopharmaceutical company.

EEOC Statement:

Sparx is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Sparx is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, genetic information, uniform service member or veteran status, or any other characteristic protected by federal, state or local law. Further, Sparx complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Sparx is an e-verify employer.