BioSpace
Sr. Director, R&D Quality and Compliance
BioSpace seeks an experienced leader to oversee R&D quality assurance across global clinical and commercial activities. The Senior Director will partner with cross‑functional teams to drive compliance with GCP, GVP, GLP, and regulatory inspections.
Job Summary The Senior Director of R&D Quality Assurance is responsible for establishing and implementing the strategy for the R&D QA function that provides Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), and research quality oversight. Strong GCP experience is required.
Duties / Responsibilities
Provide overall R&D QA leadership and strategic development for global R&D QA activities at BioSpace, its investigator sites and external service providers.
Partner cross‑functionally to enable transparency and escalation of R&D quality risks and issues, collaborating to address challenges and constraints.
Establish strong partnership with senior leaders and key stakeholders to foster a culture of quality.
Collaborate with Research leadership and other key business partners to develop and drive research quality practices that assure data compliance.
Identify and drive continuous quality process improvements through audit, inspection, and quality event outcomes.
Assist in implementation of compliant procedures and operations to ensure a robust quality management system for clinical studies and marketed products.
Serve as a resource to global clinical and safety personnel on compliance issues, external inspections, regulatory risk, and process improvement opportunities.
Lead internal and external R&D audit programs, including audit plans, priorities, and schedules.
Direct the internal and external R&D audit programs, ensuring clinical and pharmacovigilance service providers comply with applicable quality program and regulations.
Oversee R&D QA incident investigations and CAPA effectiveness.
Provide consultative R&D QA support to global clinical development activities to protect patient safety and maintain data integrity.
Function as a member of the Quality Leadership Team responsible for organizational strategy, resource planning, culture building, talent management, and stakeholder engagement.
Build and manage a high performing R&D QA team, including recruiting, training, and performance evaluations.
Requirements
Strong understanding of R&D Quality for pre‑clinical, clinical, and commercial stage work.
Expert knowledge and in-depth experience of implementing global regulations in clinical trials, pharmacovigilance, and product surveillance for cell and gene therapies.
Expert knowledge of GCP regulations (21 CFR Part 50, 54, 56, 312, 314, 11 and international equivalents).
Experience implementing and ensuring GCP, GVP, GLP quality oversight, auditing, and electronic systems management.
Experience leading and hosting regulatory authority inspections and developing responses to findings.
Proven experience developing and implementing Quality Risk Management Plans for clinical trials and safety.
Experience working with CROs, vendors, and relationship management.
Demonstrated strategic planning and execution skills.
Excellent communication skills and proven ability to influence and promote a culture of quality and excellence.
M.S. or equivalent degree and 15+ years of relevant experience, or B.S. in a scientific or allied health field and 17+ years of relevant experience.
Minimum 10 years team leadership experience.
Compensation Base salary range: $256,500 – $313,500 per year. Additional compensation includes an annual performance‑based cash bonus, new‑hire equity grant, and eligibility for annual equity awards.
EEOC Statement Intellia believes in a diverse environment and is committed to equal employment opportunity for all employees and qualified applicants. We do not discriminate in recruitment, hiring, training, or promotion for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
#J-18808-Ljbffr
Job Summary The Senior Director of R&D Quality Assurance is responsible for establishing and implementing the strategy for the R&D QA function that provides Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), and research quality oversight. Strong GCP experience is required.
Duties / Responsibilities
Provide overall R&D QA leadership and strategic development for global R&D QA activities at BioSpace, its investigator sites and external service providers.
Partner cross‑functionally to enable transparency and escalation of R&D quality risks and issues, collaborating to address challenges and constraints.
Establish strong partnership with senior leaders and key stakeholders to foster a culture of quality.
Collaborate with Research leadership and other key business partners to develop and drive research quality practices that assure data compliance.
Identify and drive continuous quality process improvements through audit, inspection, and quality event outcomes.
Assist in implementation of compliant procedures and operations to ensure a robust quality management system for clinical studies and marketed products.
Serve as a resource to global clinical and safety personnel on compliance issues, external inspections, regulatory risk, and process improvement opportunities.
Lead internal and external R&D audit programs, including audit plans, priorities, and schedules.
Direct the internal and external R&D audit programs, ensuring clinical and pharmacovigilance service providers comply with applicable quality program and regulations.
Oversee R&D QA incident investigations and CAPA effectiveness.
Provide consultative R&D QA support to global clinical development activities to protect patient safety and maintain data integrity.
Function as a member of the Quality Leadership Team responsible for organizational strategy, resource planning, culture building, talent management, and stakeholder engagement.
Build and manage a high performing R&D QA team, including recruiting, training, and performance evaluations.
Requirements
Strong understanding of R&D Quality for pre‑clinical, clinical, and commercial stage work.
Expert knowledge and in-depth experience of implementing global regulations in clinical trials, pharmacovigilance, and product surveillance for cell and gene therapies.
Expert knowledge of GCP regulations (21 CFR Part 50, 54, 56, 312, 314, 11 and international equivalents).
Experience implementing and ensuring GCP, GVP, GLP quality oversight, auditing, and electronic systems management.
Experience leading and hosting regulatory authority inspections and developing responses to findings.
Proven experience developing and implementing Quality Risk Management Plans for clinical trials and safety.
Experience working with CROs, vendors, and relationship management.
Demonstrated strategic planning and execution skills.
Excellent communication skills and proven ability to influence and promote a culture of quality and excellence.
M.S. or equivalent degree and 15+ years of relevant experience, or B.S. in a scientific or allied health field and 17+ years of relevant experience.
Minimum 10 years team leadership experience.
Compensation Base salary range: $256,500 – $313,500 per year. Additional compensation includes an annual performance‑based cash bonus, new‑hire equity grant, and eligibility for annual equity awards.
EEOC Statement Intellia believes in a diverse environment and is committed to equal employment opportunity for all employees and qualified applicants. We do not discriminate in recruitment, hiring, training, or promotion for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
#J-18808-Ljbffr