Senior Quality Assurance Specialist (QA Operations)

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 includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a clinical program in obesity. 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 Senior Quality Assurance Specialist will provide Quality Assurance (QA) oversight and support to Manufacturing, Quality Control, and Process Development, Technical services and other teams for both onsite or externalized manufacturing and testing, technology transfer, and other CMC development activities.

Experience: 

• Bachelor’s degree in biology, chemistry, or a similar scientific field 
• 8-10 years of work experience working in or with a GMP organization
• Experience with QMS, LIMS, ERP and other systems
• Experience with batch record review and QC review 
• Experience with Raw Material inspection, release and labeling 
• Experience with root cause investigation and risk assessment 
• Technology transfer (process and analytical methods) experience preferred
• Experience with Drug Substance, Drug Product, and Finished Goods (label/pack) operations
• Experience working collaboratively with CMOs is preferred
• Understanding of CMC development

Responsibilities:     

May include some or all of the following: 

• Review batch records, testing records, logs, and other documentation to ensure compliance to GDPs and governing SOPs
• Release and label raw materials
• Review and approve stability and validation protocols, data and reports to ensure compliance with internal procedures and industry guidelines
• Disposition raw materials, drug substance, drug product, and finished goods 
• Collaborate with Manufacturing to resolve equipment and process issues 
• Review and approve work orders for GMP facilities and equipment 
• QA review and approval of QS records (Deviations, CAPA, Change Controls, Risk Assessments, etc.) 
• Lead and perform investigations independently (deviations, OOS/OOT, SCARs, etc.)
• Author/Revise/Review SOPs, Training Guides/Aides, and protocols as Quality SME
• Work with applicable groups towards process improvements; including but not limited to Quality Systems improvements in support of preclinical, clinical, and commercial product development 
• Quality representative on project initiatives 
• Support audits of Wave and Regulatory Inspections 
• Occasional support of supplier and internal audits 
• On-site presence for minimum 4 days a week 
• Other duties as assigned

Key Skills: 

• Proficient with MS Word, Excel, and Outlook
• Effective written and verbal communication skills
• Superior attention to detail, strong organizational skills and the ability to multi-task and work effectively in a highly-collaborative, cross-functional, fast- paced environment
• Critical thinking, curiosity, and ability to learn independently
• Ability to influence, debate, and consider multiple perspectives
• Work harmoniously with other functional areas and stakeholders
• Experience with cGMPs and ICH regulations for drug development

Pay Range External Disclosure Statement

The annual base salary range for this position is $123,000 - $166,000

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.

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.

Salary : $123,000 - $166,000