Associate Director, Quality Assurance Operations

Role Summary

The Quality role is to act as a value-added partner enabling innovation, productivity, and continuous improvement while ensuring adherence to applicable regulations and maintaining patient safety. The successful candidate will be a subject-matter-expert on Biological GMPs across development through commercialization, provide guidance to the Quality department, and collaborate with Manufacturing, Supply Chain, and Process Development to implement fit-for-purpose quality principles. This is a hands-on, cross-functional role with risk-based decision making and primary oversight of external vendors’ quality programs.

Responsibilities

• Review and approve GMP documents for compliance to Quality Management Systems and Health Agency regulations (specifications, batch manufacturing records, stability protocols/reports, methods, process validation documents)
• Collaborate with Manufacturing and Supply Chain to resolve deviations, investigations, CAPAs, and batch record reviews; facilitate timely batch release/disposition to meet clinical and/or commercial needs
• Participate in audits of GMP service providers per Quality Management System and regulatory requirements
• Conduct Quality Management Review meetings with Executive Management to assess the Quality Management System
• Create/revise SOPs and manage SOP periodic reviews
• Upgrade Vendor Management Program by authoring/revising QA procedures
• Develop internal and external audit schedules and execute per audit plan
• Apply Risk Management principles to qualification and oversight of external service providers
• Participate in and manage regulatory inspections, including presenting the GMP Vendor Management Program
• Maintain current knowledge of GMP regulations and guidance, with a focus on vendor management expectations
• Provide ongoing guidance and ensure compliance with established systems, processes, and procedures
• Assist in development, implementation, and maintenance of GMP training and compliance programs for all personnel involved in GMP activities
• Partner with stakeholders to maintain and implement training across the organization to ensure full compliance

Qualifications

• Required: A bachelor’s degree in a scientific discipline or biotechnology field
• Required: Minimum of ten years in the pharmaceutical industry with at least five years in Quality Assurance (or master’s/doctorate with commensurate experience)
• Required: Strong knowledge of ICH, USP, 21 CFR 210, 211, 600, and EMA regulations including vendor management
• Required: Expertise in applying GMPs for Development, Clinical Supplies, and Commercial Drug Substance and Drug Products
• Required: Extensive hands-on experience in biologics manufacturing and Quality Assurance
• Preferred: Experience with launch and commercialization of a biologics product
• Required: Vendor Management (qualification audits, quality agreements, relationship building) and presenting/defending Vendor Management programs during regulatory inspections
• Required: Exception Management (deviation investigations, CAPA development, Change Control) and Product Complaints Management
• Required: Planning and conducting internal/external audits, authoring audit reports, and following up on CAPA and Risk Assessments
• Preferred: Practical experience building/maintaining Quality Systems for a virtual company
• Preferred: Experience in Risk Management and Commercial Quality Assurance operations; experience using Veeva Quality Vault
• Required: Strong cross-functional collaboration, proactive issue impact assessment on GMP compliance, and ability to interpret GMP regulations by development phase
• Required: Ability to multi-task, adapt to changing priorities, and communicate complex information effectively in a virtual environment
• Required: Excellent written and oral communication and organizational skills
• Required: Strong attention to detail and problem-solving abilities

Education

• A bachelor’s degree in a scientific discipline or biotechnology field (Required)

Additional Requirements

• Travel up to 20% to oversee contract manufacturing organizations and meet with internal teams at the New Haven HQ