Associate Director, Quality Assurance Operations

We have partnered with an exciting biotech sponsor company who are looking to hire an experienced Associate Director of Quality Assurance Operations to oversee all aspects of quality operations. This nimble, growing biotech company is focused on developing precision antibody therapies for a range of serious diseases. Join an experienced leadership team with a bright future in developing an exciting pipeline of life changing medicines.

Reporting directly to the Head of Quality, this role is a full-time and highly visible leadership position with a small team of one direct report. This position is based in our Boston metro-west headquarters, with flexibility to work from home up to 2 days per week. The successful candidate for the Associate Director of QA Operations will be primarily, but not exclusively responsible for the following:

• Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate, solution-focused mitigation plans
• Oversee all aspects of phase-appropriate clinical batch disposition
• Foster a culture of quality throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
• Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
• Review and approve quality events such as deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check, as required
• Develop, monitor, and improve quality processes, ensuring scalability and sustainability to meet the growing needs of the organization
• Develop Quality Plans and metrics to monitor QMS effectiveness
• Communicate with senior management via regular quality management review
• Lead the management review of quality compliance and operational key performance indicators to ensure the identification and timely mitigation of unfavorable trends
• Provide strategies to address compliance gaps or determine enhancements to cross functional quality systems
• Work to develop and imbue a Quality Culture across the organization
• Effectively communicate and meet deliverables and timelines
• Maintain current knowledge of pertinent industry and quality trends, standards, and methodologies.

Requirements:

• 8+ years of experience in related Biopharmaceutical Quality Operations or Compliance roles
• 5+ years direct experience in Quality Operations
• BA or BS is preferred though long-time experience in QA may be acceptable
• Strong interpersonal and organizational skills, and attention to detail
• Subject matter expertise regarding GxP operations and CMO management
• Strong leadership skills with the ability to thrive in a high throughput environment
• Ability to lead and manage projects and teams within corporate objectives and project timelines
• Previous experience with CMO management including Veeva QMS, and ComplianceWire
• Results driven and independent mindset with the ability to work with little instruction.
• Travel up to 15% of the time may be required to attend meetings, conferences, and industry events

Our client values a diverse workforce and provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.