HighRes Biosolutions
The Quality Assurance (QA) Manager is responsible for ensuring that all products and processes within the company comply with applicable quality standards, regulatory requirements and internal procedures. This role will lead the development, implementation, and maintenance of the company’s Quality Management System (QMS). The QA Manager plays a key leadership role in audits, continuous improvement, and fostering a culture of quality across the organization.
Responsibilities
Develop, implement, and manage the Quality Management System (QMS) aligned with applicable regulations.
Lead internal and external audits (e.g., supplier audits, customer audits/inspections, regulatory inspections, ISO recertification audits, etc).
Oversee document control, CAPA, change control, training, and deviation management systems.
Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality compliance.
Monitor and report KPIs and trends; provide regular updates to senior management.
Investigate quality issues and drive root cause analysis and corrective/preventive actions (CAPAs).
Track and trend quality metrics to identify systemic issues and drive resolution.
Support product release activities including record review and quality approvals.
Maintain readiness for regulatory inspections and act as a point of contact for inspectors/auditors.
Lead training programs on quality policies and procedures.
Manage and develop quality assurance staff, fostering team growth and accountability.
Qualifications
Bachelor’s degree in Business, Engineering, Life Sciences, or related field.
5–10+ years of experience in quality assurance, preferably within the biotechnology, pharmaceutical, or medical device industry.
Strong knowledge of cGMP, GLP, and/or GCP regulations and applicable quality standards (e.g., ISO 9001/13485, ICH guidelines).
Experience with regulatory inspections (e.g., audits) and managing audit responses.
Proficiency with quality tools and methodologies (e.g., CAPA, RCA, FMEA, SPC).
Proven leadership and team management experience.
Excellent problem-solving, analytical, and organizational skills.
Strong written and verbal communication skills.
Preferred Skills
Experience working in a startup.
Experience in life sciences automation, robotics, or capital equipment manufacturing.
Working knowledge of regulatory requirements in the biotech/pharma industry.
Some experience integrating sustainability into supplier management, process improvement, and product lifecycle to support environmental responsibility across the value chain.
About HighRes We design and build innovative robotic systems and laboratory devices used by pharmaceutical and biotech companies and academic research laboratories. Our work helps scientists accelerate drug discovery, high throughput genotyping, siRNA screening, next-generation sequencing sample prep, biorepository science and molecular diagnostics with highly flexible, expandable, and modular integrated systems, bench-top devices and consumables that are easily configured (and reconfigured) to create research environments conducive to achieving breakthrough results.
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Responsibilities
Develop, implement, and manage the Quality Management System (QMS) aligned with applicable regulations.
Lead internal and external audits (e.g., supplier audits, customer audits/inspections, regulatory inspections, ISO recertification audits, etc).
Oversee document control, CAPA, change control, training, and deviation management systems.
Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality compliance.
Monitor and report KPIs and trends; provide regular updates to senior management.
Investigate quality issues and drive root cause analysis and corrective/preventive actions (CAPAs).
Track and trend quality metrics to identify systemic issues and drive resolution.
Support product release activities including record review and quality approvals.
Maintain readiness for regulatory inspections and act as a point of contact for inspectors/auditors.
Lead training programs on quality policies and procedures.
Manage and develop quality assurance staff, fostering team growth and accountability.
Qualifications
Bachelor’s degree in Business, Engineering, Life Sciences, or related field.
5–10+ years of experience in quality assurance, preferably within the biotechnology, pharmaceutical, or medical device industry.
Strong knowledge of cGMP, GLP, and/or GCP regulations and applicable quality standards (e.g., ISO 9001/13485, ICH guidelines).
Experience with regulatory inspections (e.g., audits) and managing audit responses.
Proficiency with quality tools and methodologies (e.g., CAPA, RCA, FMEA, SPC).
Proven leadership and team management experience.
Excellent problem-solving, analytical, and organizational skills.
Strong written and verbal communication skills.
Preferred Skills
Experience working in a startup.
Experience in life sciences automation, robotics, or capital equipment manufacturing.
Working knowledge of regulatory requirements in the biotech/pharma industry.
Some experience integrating sustainability into supplier management, process improvement, and product lifecycle to support environmental responsibility across the value chain.
About HighRes We design and build innovative robotic systems and laboratory devices used by pharmaceutical and biotech companies and academic research laboratories. Our work helps scientists accelerate drug discovery, high throughput genotyping, siRNA screening, next-generation sequencing sample prep, biorepository science and molecular diagnostics with highly flexible, expandable, and modular integrated systems, bench-top devices and consumables that are easily configured (and reconfigured) to create research environments conducive to achieving breakthrough results.
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