Senior Director, R&D Quality Assurance

Wave Life Sciences; Lexington (MA); On-site; USD 236,000 - 320,000; Full time

Benefits offered by this job

Health insurance

401K with matching

Employee Stock Purchase Program

Generous PTO

Job summary

Wave Life Sciences seeks an experienced Quality leader to provide independent, risk-based oversight across Clinical, Nonclinical, and Pharmacovigilance activities. Reporting to the Executive Director, R&D Quality Assurance, this role combines leadership with hands-on execution to strengthen the R&D quality framework.

The ideal candidate has 15+ years in biotech/pharma quality, including 10+ years in a GxP environment, and a proven track record hosting inspections, writing audit reports, and

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• At least 15 years of progressive pharmaceutical/biotech Quality experience.
• 10+ years in a GxP environment with senior leadership responsibility.
• Broad experience in GCP, GVP, GLP across Clinical, Nonclinical, PV.
• Sponsor-side oversight of outsourced development activities.
• Experience leading health authority inspections and responses.
• SOP authorship, training development, and process improvements.

Responsibilities

• Provide GCP and GVP Quality guidance across Clinical Operations, Drug Safety, Data Management, and Regulatory.
• Identify risks to participant safety and data integrity; ensure regulatory compliance.
• Oversee CROs, investigator sites, labs, and vendors; assess monitoring and informed consent risks.
• Provide QA oversight of PV activities, including safety case management and reporting processes.
• Lead SOP development and CAPA processes; drive quality performance improvements.

Skills

Leadership

Regulatory communication

Audits & inspection readiness

Risk assessment

Cross-functional collaboration

Quality metrics

Education

Bachelor’s degree in science

Tools

Veeva

Electronic QMS

Job description

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

Wave seeks an experienced Quality leader to provide independent, risk-based oversight across Clinical, Nonclinical, and Pharmacovigilance activities. Reporting to the Executive Director, R&D Quality Assurance, this individual will help strengthen the R&D quality framework and sponsor oversight of outsourced studies and services. This role combines leadership with direct execution. The successful candidate will bring broad GCP, GVP, and GLP Quality experience gained in a midsize to large biotechnology organization, take initiative with limited direction, and personally deliver audits, inspection preparation, investigations, SOPs, and process improvements. A collaborative approach, sound judgment, and consistent follow-through are essential.

Experience

• Bachelor’s degree in a scientific or related discipline, advanced degree preferred
• At least 15 years of progressive pharmaceutical or biotechnology Quality experience, including at least 10 years in a GxP environment and demonstrated senior leadership responsibility
• Broad, direct experience across GCP, GVP, and GLP Quality, including Clinical, Nonclinical, and Pharmacovigilance oversight in a midsize to large biotechnology organization
• Demonstrated sponsor-side oversight of outsourced development activities and the ability to apply established quality practices in a growing organization
• Substantial experience leading and hosting health authority inspections and managing inspection preparation, responses, and remediation
• Proven experience conducting audits, writing clear audit reports, assessing CAPAs, and resolving significant quality issues
• Demonstrated SOP authorship, training development, and implementation of process improvements that remain effective in routine operations
• Working knowledge of applicable US and international GCP, GVP, and GLP requirements, data integrity principles, and electronic records controls
• Experience with electronic QMS and document management systems, Veeva experience preferred

Responsibilities

Clinical and pharmacovigilance quality

• Provide GCP and GVP Quality guidance to Clinical Operations, Clinical Development, Drug Safety, Data Management, Biostatistics, Regulatory, and other partners
• Identify and elevate risks to participant safety, data integrity, and regulatory compliance
• Oversee clinical program quality and sponsor oversight of CROs, investigator sites, laboratories, and specialty vendors, including assessment of risks related to monitoring, protocol deviations, informed consent, investigational product accountability, blinding, and essential records
• Provide independent QA oversight of outsourced and internal PV activities, including safety case management, reporting processes, reconciliation, vendor interfaces, and applicable safety system documentation
• Partner with functional owners to define responsibilities, strengthen oversight records, and resolve cross-functional quality issues while maintaining QA independence

Nonclinical quality oversight

• Develop and implement sponsor GLP Quality oversight for outsourced nonclinical studies, including toxicology and developmental and reproductive toxicology studies
• Partner with Nonclinical Development on vendor qualification, study risk assessment, oversight plans, significant deviations, and study data and report quality
• Assess test facility QA arrangements and sponsor interfaces for test articles, dose formulations, specimens, data transfers, retention, and archives
• Develop nonclinical procedures and integrate applicable activities into shared QMS processes, with clear separation of sponsor responsibilities and test facility responsibilities

Audits and regulatory inspections

• Develop and execute risk-based GCP, GVP, and GLP audit plans, conducting vendor, investigator site, system, process, and study audits within areas of expertise and engaging specialist auditors as needed
• Lead all aspects of audit execution, including planning, interviews, evidence review, reporting, and assessment of auditee responses, while tracking CAPA implementation and effectiveness through closure
• Lead and host sponsor inspections within assigned scope and support investigator site and vendor inspections, including readiness assessments, mock inspections, document requests, SME coordination, and inspection communications
• Draft and coordinate inspection responses and remediation plans, escalating significant findings and providing progress updates to the Head of R&D Quality

Quality systems and process improvement

• Personally author, revise, and implement SOPs, work instructions, templates, and training across GCP, GVP, and GLP activities
• Lead or support investigations, root cause analysis, CAPA, change control, and quality risk management assessing impact and escalating significant or recurring issues
• Identify process gaps and implement proportionate improvements with functional owners, using quality metrics and trends to assess performance and sustained effectiveness
• Coordinate assigned staff, contractors, and consultants, clarify deliverables, and coach colleagues while remaining accountable for personal execution

Key Skills

• Self-directed and resourceful, with the willingness to move between strategic planning and detailed operational work
• Collaborative and approachable, with a constructive, can-do attitude and the ability to influence across functions
• Strong written and verbal communication, including clear regulatory responses, SOPs, and concise leadership updates
• Sound judgment and professional courage to raise concerns, recommend practical solutions, and preserve independent Quality decisions
• Strong organization and follow-through, with the ability to prioritize competing commitments and deliver with limited supervision
• Ability to lead through change, coach others, and work effectively with internal teams and external partners

Pay Range Disclosure Statement: $236,000 USD - $320,000 USD

The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees’ and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program.

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.