Strategic R&D Quality Leader

Biopharma Careers; Billerica (MA); On-site; USD 142,000 - 213,000; Full time

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other perquisites

Job summary

Biopharma Careers seeks an R&D Quality Strategy Lead to partner with development programs across the product lifecycle, embedding quality in decision-making and ensuring regulatory readiness.

You will drive risk management, conduct program audits, and oversee deviation handling while collaborating with Clinical Development, Regulatory, and other R&D functions to uphold global GxP standards.

Qualifications

• Bachelor's degree in a scientific or quality-related field is required; advanced degree preferred.
• Minimum 10 years of experience in Quality Assurance or a related pharmaceutical/biotech field.
• Strong knowledge of drug development processes and global GCP regulations.

Responsibilities

• Lead Program Quality Strategy and develop the quality strategy for assigned development programs.
• Define and oversee risk assessments, program audit strategy, and other QA activities.
• Provide quality expertise during due diligence and key business decisions.
• Support continuous improvement and quality-by-design approaches across programs.

Skills

Quality assurance

Risk management

Stakeholder management

Inspection readiness

Quality-driven decision making

Continuous improvement

Root cause analysis

Quality strategy development

Cross-functional collaboration

Education

Bachelor's degree in a scientific or quality-related field

Advanced degree preferred

Job description

Biopharma Careers seeks an R&D Quality Strategy Lead to partner with development programs across the product lifecycle, embedding quality in decision-making and ensuring regulatory readiness.

You will drive risk management, conduct program audits, and oversee deviation handling while collaborating with Clinical Development, Regulatory, and other R&D functions to uphold global GxP standards.