Associate Director (AD) Quality Assurance- Boston MA

Associate Director, Quality Assurance

The Associate Director, Quality Assurance is accountable and responsible for the execution and oversight of the GxP Quality Management System and Compliance activities related to the cGMP manufacture and release of products in accordance with ICH guidelines and US, EU, and other applicable regional regulations. This role requires leadership in a highly proactive manner to promote awareness of applicable regulatory and Quality Management System (QMS) requirements, identify gaps, and drive solutions to support product life cycle management in regards to product quality, efficacy, and safety. This position involves collaborative cross-functional teamwork with a positive attitude while managing and resolving conflicts and maintaining a good rapport.

This position requires expertise in current Good Manufacturing Processes (cGMP), along with proficiency in Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) and relevant regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement that will focus on delivering efficiencies.

This position allows for hybrid work with 2-3 days/week requiring onsite attendance. Fully remote can be considered for the right candidate depending on proximity to the office.

Major Duties/Responsibilities

• Write Quality documentation including specifications, SOPs and Policies.
• Responsible for the Vendor Management program to ensure appropriate and timely vendor qualification, audits, and maintenance.
• Manage all aspects of the audit lifecycle including scheduling, planning, issuing audit agendas, report review, evaluating responses, and closure of audits.
• Provide GMP Quality Assurance oversight of products manufactured at facilities, if applicable, and at Contract Manufacturing Organizations.
• Process owner for Quality Agreements with GMP vendors.
• Lead the Vendor Management program by identifying opportunities and implementing risk-appropriate improvements to the vendor oversight process.
• Oversee GMP Quality operations at facilities, if applicable, and CMOs, with a focus on quality activities, including quality documentation reviews and approvals and executing on quality disposition of products.
• Support PPQ activities which will include review of process validation protocols/reports, risk assessments, method validation protocols, and all associated reports.
• Provide guidance to internal stakeholders to assess risk management strategies, vendor selection, monitoring, and remediation.
• Responsible for the awareness of vendor status as it pertains to qualification, QAA, supplier notification, and inspections.
• Develop and direct effective quality assurance oversight of the investigation and resolution of deviations, CAPA, and complaints investigations.
• In partnership with cross-functional teams, contribute to continuous improvement of the investigations, CAPA, and product complaints programs.
• Proactively seeks to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.
• Support Functional Area QA and audit team to resolve observations arising from audits.
• Develop, implement and maintain procedures and policies.
• Participate in risk assessments and supplier change management processes.
• Promote a quality mindset and quality excellence approach to all activities.
• Establish and support quality systems and operations, including document control, change controls, deviation, CAPA, effectiveness checks, and investigations.
• Improve quality processes and systems and seek continued improvement.
• Support and review relevant sections of IND/IMPD/BLA/NDA and other applicable regulatory submissions.

Education Professional Experience

Required:

• Minimum of 7 years of QA GMP experience in the Biotech/Pharmaceutical industry; QA GxP experience desirable but not required.
• BS degree in a scientific discipline is required; a post-graduate degree is a plus.
• Current and strong working knowledge of quality and development guidelines.
• Driven, results-oriented self-starter and excellent team player.
• Creative and pragmatic approach to problem-solving and issue resolution.
• Knowledge of regulatory requirements specific to vendor selection, qualification, and oversight.
• Strong management and process improvement skills.
• Demonstrated excellent verbal, written, and interpersonal skills.
• Demonstrated experience leading and contributing through influence and working in cross-functional teams.