Bioinformatics Quality Documentation Lead

The Bioinformatics Quality Management Lead is responsible for overseeing quality, compliance, and regulatory needs for bioinformatics operations in a clinical diagnostics lab under CAP/CLIA requirements. This role requires a strong background in software development knowledge to impact regulatory needs and ensure compliance. The Lead will handle all documentation needs, support the team in maintaining compliance at all times, and assist during quality audits.

This professional will work 3 days a week onsite at one of the following locations of his/her choice:

Marlborough, MA
Lewisville, TX
San Juan Capistrano, CA

• Develop and implement documentation processes and procedures to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to gather and maintain accurate documentation for bioinformatics operations.
• Review and update existing documentation to reflect changes in regulations or processes.
• Train team members in documentation best practices and regulatory requirements.
• Coordinate responses and corrective actions during quality audits to address any findings related to documentation.
• Stay current on industry regulations and best practices to proactively address compliance issues.
• Participate in internal and external audits as a subject matter expert on documentation practices.

Required WorkExperience:

• Minimum of 3 years of experience working in a clinical diagnostics lab under CAP/CLIA regulations.
• In-depth knowledge of regulatory requirements in the healthcare industry, including HIPAA, CLIA, CAP, GDP, CFR Title 21, and ISO 13485. Preferred: ISO 14971, ISO 15189, IVDR, and NYSDOH requirements.
• Experience developing and implementing documentation processes in a regulated environment.
• Excellent written and verbal communication skills with keen attention to detail.
• Ability to work collaboratively with team members at all levels and external auditors.
• Certification in regulatory affairs or quality management (e.g., RAC, CQM) is highly desirable.

Preferred Work Experience:

• 5+ years of experience working in a clinical diagnostics lab under CAP/CLIA regulations.
• Certification in Regulatory Affairs (RAC) or Quality Management (CQM).
• Strong proficiency in programming languages commonly used in bioinformatics, such as Python or R.
• Agile certification

Physical and Mental Requirements:

• Strong attention to detail for thorough documentation to ensure consistency in documentation.
• Excellent problem-solving skills to identify and address quality issues effectively.
• Ability to manage multiple projects and work across multiple sites to meet deadlines while maintaining accuracy.
• Must be able to occasionally move and lift objects of up to 25 pounds.

Knowledge and Skills:

• Broad-based technical knowledge and skills of software validation principles in regulated environment, design controls, risk management.
• Demonstrated knowledge for software development lifecycle models (waterfall, Agile, V-model)
• Ability to work independently and collaboratively with cross-functional departments in a fast-paced environment with minimal supervision.
• Proficient in document management systems.

Required:

• Bachelor's degree in Bioinformatics, Computer Science, or a related field with a strong emphasis on software development.
• Travel up to 15%

Preferred:

• Master's degree in Bioinformatics, Computer Science, or a related field.
• Agile certification