Senior Research Quality Analytics Specialist (ADX-329-20) at ArcherDX
The Senior Quality Analytics Specialist will lead diverse cross-functional teams in the pursuit of quality analytical services in compliance with appropriate regulations such as GMP (good manufacturing practice), GLP (good laboratory practice), and GCP (good clinical practice). Areas of direct influence will include, but not be limited to, quality control testing, test method validation, tech transfer, process validation, continual process improvement, product stability program design and execution, laboratory management, product specifications, and risk assessments. This role shall provide strategic leadership to establish and maintain quality levels that consistently deliver best-in-class products that comply with US FDA Regulations, as well as Regulations of OUS markets and manufacturing sites.
- Identify and lead continuous process improvement initiatives that improve the customer experience, enhance workflow, business and manufacturing processes and/or improve the work environment.
- Liaise with early discovery and development partners to drive the continuous flow of knowledge from manufacturing to early research speeding development and reducing time to market for new products.
- Organize and oversee management of Quality principles for SPC, Quality-by-Design (QBD), Quality Control, Test Method and Process Validation, Tech Transfer and stability teams, including the review and approval of protocols and reports.
- Foster a strong QBD culture striving for continuous quality improvement throughout the entire company.
- Engage in driving the quantitative assessment of specification setting, release limits, process monitoring metrics, and risk assessments.
- Provide strategic analytical leadership throughout the product development process and ensure strong quality domain representation in product development and manufacturing services teams
- In conjunction with cross functional leaderships develop appropriate metrics, and tools for data collation.
- Oversee investigations of laboratory issues to insure timely, closed loop corrective actions and reports as required through CAPAs.
- Lead by example to create an inclusive culture that values high engagement driven to continuous improvement.
- Participate in the development of education and training programs for quality initiatives, such as quality-by-design (QBD), utilization of Design-of-Experiments (DOEs), SPC and quality monitoring.
- Passion for enhancing healthcare outcomes with novel technology.
- Problem solver, comfortable operating in the grey-space and driving forward with risk balanced decision making.
- History of thriving in a fast-paced, dynamic environment.
- Inspirational team player with a passion for science and driving to solutions.
- Driven to perform
- Self-directed, curious, and motivated to understand the business, technical, scientific and regulatory aspects of the business.
- Able to organize and prioritize
- Strong leadership and communication skills
- Minimum of 5-10 years experience in two or more of the following areas is required: quality, regulatory, laboratory experience, statistics, six-sigma, engineering.
- Knowledge of biology, genetics, familiarity with genomic data, proficiency in molecular techniques, NGS preferred.
- Working knowledge of cGMP/CFR/FDA regulations, with knowledge of OUS regulations.
- Experience with applicable FDA regulations and ISO standards, working knowledge of international regulations strongly preferred
- A minimum of a master’s degree in statistics, genetics, or related field is required
- Advanced Degree preferred