New · posted Oct 20
Wave Life Sciences USA · Biotechnology
Senior Director, R&D Quality Assurance
- Lexington, MA
- On-site
- Full-time
- Director
Open until filled
The role
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.
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.
What you need
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
- 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—$320,000 USD
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.
What you'll do
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 escalate 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
Pay and benefits
$236,000 – $320,000 a year
Employer providedMedical, dental, vision, life and disability insurance
Generous paid time off including summer and winter company shutdowns
401(k) with matching contributions
Employee Stock Purchase Program
Discretionary annual bonus
Discretionary stock-based long-term incentives
Where you'll work
Lexington, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Lexington, MAEqual opportunity, accessibility and legal noticesWave Life Sciences USA's statements, word for word
Data Privacy and Your Information
By submitting your information in applying for a position at Wave (or lawfully on behalf of a candidate as an approved recruiter), you represent that the information you submit (including your name, phone number, email address, address, and resume/CV/work history) is true and accurate, you have the right to share it, and that no part of the Information violates or infringes the rights of any third parties. If you submit information lawfully on behalf of another applicant as an approved recruiter, you confirm that you have the right to so submit. You grant Wave permission to use your information to contact you in connection with this or another position, for interviews, scheduling purposes, travel arrangements, or follow up after a decision on the role has been made.
Wave Life Sciences is committed to respecting your privacy. We do not sell or rent personal information to third parties for marketing purposes. Any Personal Information you share with us will be used for business purposes, such as communication with you, and handled in accordance with Wave’s Privacy Policy, Notice, Statements, and Additional Information. Wave collects, evaluates and retains candidate data for the legitimate interest of selecting a candidate for employment or contract purposes. Such data will be kept for no longer than necessary to carry out those purposes, unless you consent for your information to be retained up to an additional three (3) years for consideration for future opportunities at Wave. Any requests related to your Personal Information may be electronically submitted to Wave’s Data Protection Officer at https://wavelifesciences.com/privacy/.
If you choose to share your demographic background (such as race, gender or sex, national origin, age, disability or veterinary status) by completing the optional survey, your responses will be combined with the answers from other applicants in an aggregated and anonymized form which may be used for equal employment opportunity reporting, diversity and inclusion analysis, and to help us evaluate the effectiveness of our recruiting practices. The information you share will not be used for hiring decisions or provided to hiring managers or interviewers.
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.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 33% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US104 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $236,000 | — | $320,000 |
| Massachusetts (middle half) | $186,000 | $200,000 | $231,000 |
| All US (middle half) | $186,000 | $209,250 | $232,625 |
This role: Wave Life Sciences USA's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Wave Life Sciences's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 38 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance14
- Documentation and SOPs13
- Collaboration and leadership13
- Investigations and CAPA7
- Quality systems and risk7
- Data and digital systems4
- Lab testing and methods3
- Validation and qualification1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Wave Life Sciences on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Quality4 100%
By level
- Director2 50%
- Associate & Specialist2 50%
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Senior Director, R&D Quality Assurance at Wave Life Sciences
Open until filled. $236K–$320K a year, employer provided.