Associate Director, Quality Operations

Wave Life Sciences • Lexington, MA

51d

About The Position

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 preclinical 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 Associate Director, Quality Operations leads a team of QA personnel who oversee all GMP quality operations across Wave, inclusive of internal plant and external CMO and CMC activities. This individual will collaborate and partner closely with various CMC departments to ensure day-to-day activities maintain compliance with regulations in a phase appropriate manner.

Requirements

• Bachelor’s degree with minimum 10 years of experience in life sciences, with a minimum of five years of Quality Assurance and Quality Control experience in development and commercial programs
• At least 5 years of personnel management experience
• US and EMA regulations, ICH Guidelines
• Previous experience working with CMOs, drug product manufacturing, sterility assurance, QP interactions, and labeling/packaging operations
• Previous experience overseeing internal manufacturing facility as QA
• Strong interpersonal skills to provide coaching, training, and direction
• Proven ability to identify quality issues/discrepancies through a risk-based approach and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner, both internally at Wave and with external collaborators
• Strong written, communication, and organization skills
• Capable of managing and shifting priorities to meet critical deadlines in a fast paced and dynamic environment
• Experience influencing across the organization to improve products or processes
• Ability to travel domestically and internationally up to 10%

Nice To Haves

• Experience working within a CMC team is desired

Responsibilities

• Lead the Quality Operations function and develop the team’s personnel to support a risk-based, value-added approach to product quality oversight
• Represent Wave QA to internal manufacturing facility, contract manufacturing (CMO), and contract test organizations (CTO), working collaboratively with manufacturing, QC, engineering, and other cross functional teams to come up with compliant solutions
• Work collaboratively with colleagues to actively manage drug disposition activities for drug substance, drug product, and finished goods, including the timely resolution of Quality Events to enable compliant release
• Continuous improvement of quality processes and ownership of quality metrics
• Develop and maintain SOPs for QA operations for oversight of the manufacturing, testing and release of raw materials, drug substance and drug product
• Review and approval of material/product specifications, master batch records, executed batch records, stability protocols, stability reports, etc.
• Quality System ownership for internal and external deviations, CAPAs, change controls, product complaints, shipping excursions, and laboratory OOS or OOT as needed
• Manage the review and approval of tech transfer documentation: characterizations, method qualifications, validation and verification protocols and reports
• Represent QA in cross functional team meetings and communicate needs and timelines
• Escalate quality issues
• Collaborate on the execution of quality strategy, improvements, and other projects
• Support audits and on-site oversight of suppliers and service providers as needed
• Other duties as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees