Director, Quality Systems

Wave Life Sciences; Boston (MA); On-site; USD 193,000 - 261,000; Full time

Job summary

Wave Life Sciences is seeking a Director of Quality Systems to lead foundational quality processes and the eQMS at our Lexington facility. This onsite role focuses on GMP/GxP areas with a strong emphasis on continuous improvement, training, and vendor management.

Four days/week onsite is required, with strategic leadership across QA and regulatory functions. The role requires a BS in a science, 10–12 years in QA within pharma, and deep experience implementing QMS, CV/CSV systems, and vendor

Qualifications

• BS in a scientific discipline.
• 10–12 years QA experience in the pharmaceutical industry with 5 years of people management.
• Significant expertise with QMS, Documentation and Learning Management systems.
• Minimum 3 years’ experience with Vendor Qualification and Management.
• Ability to influence peers, coach others, and lead teams to meet timelines.

Responsibilities

• Improve and streamline QMS processes such as Change Control, Deviations, CAPA, Documentation, Training and Vendor Management.
• Develop a staged plan to achieve inspection readiness and build a QS team culture.
• Oversee development, maintenance, and optimization of QS policies, procedures and templates.
• Ensure QS processes comply with global regulatory requirements (FDA, EMA, ICH).
• Establish and monitor eQMS performance metrics and drive cross-functional improvements.
• Lead audits and regulatory inspection preparation and responses.

Skills

QA leadership

GXP knowledge

Vendor management

eQMS systems

Documentation management

Regulatory liaison

CSV experience

Cross-functional collaboration

Education

BS in scientific discipline

Tools

Veeva experience

QMS software

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

The Director, Quality Systems (QS) leads the internal team at Wave responsible for foundational quality processes: GXP Training, Document Control, Vendor Management, and Wave’s electronic Quality Management System (eQMS). This role is responsible for the continuous improvement and compliant operation of these processes to meet patient and business needs as Wave progresses from investigational products towards commercialization. This role is primarily focused on supporting GMP areas with some support of GXP. This is an onsite position requiring 4 days/week onsite presence at our Lexington facility.

Experience

• BS in a scientific discipline
• Minimum 10-12 years’ experience in Quality Assurance in the pharmaceutical industry and 5 years managing personnel
• Significant expertise with implementation and improvement of enterprise systems: Quality Management Systems, Documentation Systems, and Learning Management Systems
• Minimum 3 years’ experience with Vendor Qualification and Management
• Demonstrated capability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues
• Ability to identify technical problems and suggest resolution of the issues
• Strong collaboration and communication skills
• Ability to manage timelines for oneself and others
• Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance and familiarity with drug development is a plus.

Responsibilities

• Improve and streamline existing QMS processes, such as Change Control, Deviations and CAPA Management, Document Management, GxP Training, and Vendor Management
• Assess current state of Quality Systems at Wave and develop a staged plan to arrive at inspection readinessDevelop a team of QS personnel fostering a culture of collaboration, continuous improvement and customer service
• Oversee the development, maintenance, and optimization of QS policies, procedures, and templates
• Ensure that all QS processes comply with applicable global regulatory requirements (e.g., FDA, EMA, ICH, etc.)
• Establish and monitor eQMS performance metrics to ensure process effectiveness and compliance.
• Lead cross-functional initiatives to identify and implement process improvements.
• Foster a culture of innovation and proactive problem-solving within the QS team
• Act as a liaison between the QS team and other departments to ensure alignment of quality processes with business operations
• Communicate QS processes strategies, updates, and key metrics to senior leadership and other stakeholders
• Lead preparation and response activities for internal and external audits and regulatory inspections
• Other duties as assigned

Key Skills

• Hands-on self-starter with the ability to collaborate and work closely with various teams and line functions to ensure GMP standards and compliance with global regulations
• Demonstrated ability to coach and develop personnel
• Strong change management skills with a customer service mindset
• Excellent written, verbal and presentation skills for effectively interfacing with collaborators and customers
• Ability to assess and navigate complicated issues, break down the components, and devise practical short-term solutions while formulating long-term fixes
• Strong organizational skills with the ability to effectively multi-task and prioritize
• Ability to adapt to changing business needs and meet timelines within a fast-paced environment
• Self-motivated with sound judgement and problem-solving skills
• Veeva experience highly desired
• Expertise in CSV principles through implementation of electronic systems desired
• Combination product experience is a plus

Pay Range Disclosure Statement

$193,000—$261,000 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.

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