Director, GMP Operational Quality

Vertex Inc.•Boston, MA

1d•Onsite

About The Position

The Director, Quality Assurance GMP Operations will oversee the GMP QA operations including batch disposition process across CDMOs in the US and Internationally. Responsibilities include day-to day operational quality oversight for internal batch record review operations and QA manufacturing operations from clinical to commercial stage of product globally. The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities participation of governance committees associated with improvements to the disposition process. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities. The role may support on site internal manufacturing activities. The role is a 5 days on site role at Vertex in the Boston Seaport.

Requirements

Bachelor's degree or Master's degree or equivalent
10+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment
In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs).
Broad and current knowledge of batch disposition industry trends and best practices in Cell/Gene therapies.
Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
Proven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
Ability to apply risk management principles to decision making and operational priorities.
Critical Thinking and Problem Solving skills
Ability to closely collaborate and build relationships with internal and external stakeholders.

Nice To Haves

QA Operational experience for Autologous Cell Therapy Operations.
Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.

Responsibilities

Establishment of quality oversight for internal quality and external CTO/CDMO operations for the batch disposition process, across development, launch and commercial manufacturing globally.
Proactively drives continuous improvements in processes, identifies and mitigates compliance gaps and drive culture of quality across all operational activities.
Manage the day-to-day timely release of finished product to ensure compliance with Regulatory and Vertex cGMP requirements.
Represent Quality and serve as a trusted partner for the disposition activities of drug product.
Lead and mentor other team members, support development of organizational capabilities and talent building.
Assure disposition activities across CDMOs are compliant and consistent.
Ensure adequate training to the Department personnel.
Manage the department resources with regards to budget and personnel.
Build strategic relationships with internal and external partners – CDMOs and CTOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary.
Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
Develop, establish, and implement Batch disposition operational Quality and Compliance metrics.
Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits.
Establish/participate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
May be required to support manufacturing on site activities.