Associate Director, Quality Operations

Role Summary

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. Collaborates with various CMC departments to ensure day-to-day activities maintain compliance with regulations in a phase appropriate manner.

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

Qualifications

• Required: 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
• Required: At least 5 years of personnel management experience
• Required: US and EMA regulations, ICH Guidelines
• Required: Previous experience working with CMOs, drug product manufacturing, sterility assurance, QP interactions, and labeling/packaging operations
• Required: Previous experience overseeing internal manufacturing facility as QA
• Preferred: Experience working within a CMC team

Skills

• 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%