Associate Director, QA Manufacturing Technical Services

Vertex Inc.•Boston, MA

11d•$156,600 - $234,800•Onsite

About The Position

The Associate Director, Quality Assurance Manufacturing Technical Services (Internal) is responsible for supporting the day-to-day Quality Operations for internal manufacturing of Cell & Gene Programs through the management of quality management system (QMS) events. The role provides Quality oversight for technical and operational manufacturing activities from facility start-up through product commercialization, post-approval process monitoring, and deviation management. The role is also responsible for building strong partnerships with internal cross-functional teams to drive compliance, monitor performance, support continuous improvement, and provide quality presence and real-time support on the manufacturing floor. The role will closely partner with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, and other operational stakeholders, and participate in associated governance for the successful planning and execution of the QMS. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and a visible quality partner supporting internal manufacturing operations.

Requirements

In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
Experience in product life cycle from discovery to commercials product development
Broad understanding of regulatory environment, including quality systems, compliance, and strategy.
Broad technical knowledge in cell technology, aseptic manufacturing operations, analytical assays, cell & genetic therapies/biologics processing, fill/finish, and testing, with the ability to apply that knowledge in support of internal manufacturing operations.
In-depth knowledge of deviations, root cause analysis, CAPA, and change control processes
Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
Substantial experience with electronic document management systems (e.g., Trackwise, Veeva)
Excellent communication skills with the ability to present complex information and a proven track record of influencing, building, and promoting a culture of Quality and Excellence across manufacturing operations and on the production floor.
Ability to apply risk management principles to decision-making and operational priorities.
Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers.
Critical Thinking and Problem-Solving skills
Strong leadership and an innate ability to collaborate and build relationships.
Bachelor's degree in a biotech/life sciences field.
Typically requires 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

Nice To Haves

Master's degree or relevant comparable background.

Responsibilities

Lead, execute, and oversee the deviation management process across all stages of manufacturing, from identification to closure.
Ensure proper investigation, documentation, and resolution of all deviations in accordance with internal policies and regulatory requirements.
Provide quality and technical expertise in the investigation of deviations including OOS/OOTs, conduct thorough root cause analysis to identify underlying issues, and oversee efficient and effective implementation of corrective and preventive actions (CAPA) to prevent recurrence.
Partner closely with Manufacturing, Quality Control, MSAT, Engineering, Supply Chain, Regulatory Affairs, and other Quality functions to ensure timely and effective resolution of deviations and alignment with patient safety, product quality, and regulatory compliance.
May require flexibility to work in shifts to support manufacturing and operations, and/or to engage with appropriate stakeholders.
Ensure that all deviation investigations comply with relevant regulatory standards (such as FDA, EMA, cGMP) and company policies.
Maintain awareness of and ensure compliance with industry best practices and regulatory guidelines.
Establish and maintain deviation tracking systems, ensuring that all deviations are properly documented, categorized, and monitored for timely resolution.
Prepare and present regular reports on deviation metrics to senior leadership.
Lead and execute continuous improvement activities and drive quality remediation.
Identify potential risks and trends related to deviations and work proactively to mitigate such risks with preventive measures.
Support risk assessments to evaluate the impact of deviations on product quality, safety, and regulatory compliance.
Ensure that all deviation records are maintained in a compliant and audit-ready manner.
Lead or support internal and external audits related to deviation management, ensuring all required documentation is available and accurate.
Participate in operational review and escalation meetings to ensure Quality issues are appropriately raised, assessed, and addressed in support of internal manufacturing operations.
Provide routine on-the-floor Quality support for manufacturing operations, including real-time troubleshooting, batch execution support, escalation of quality issues, and guidance to operations personnel to ensure compliance with procedures and cGMP requirements.
Serve as a visible Quality presence in manufacturing areas to facilitate compliant and rapid resolution of issues.
Participate in Cell & Genetic Program and Quality projects.