Sr. Director, Quality Operations

ProKidney•Winston-Salem, NC

About The Position

Position Summary: The Senior Director, Quality Operations – is responsible for leadership of all aspects of GMP Quality Assurance overseeing the production of all ProKidney drug products at all manufacturing sites, as well as individual contributions, to establish and support long-term quality operations for ProKidney. In addition to product release and disposition, this position is responsible for overseeing all aspects of Material release and disposition as well as all GMP equipment and GMP facility-related validations (e.g. EMPQ). This role will manage and execute Quality Assurance as it is directly related to batch and material release for clinical trial material supply and that directly related to the establishment of a phase III/commercial GMP quality system. The leader in this role must assure that quality systems and controls are effectively in-place for phase III investigational new drug GMP manufacturing (investigational medicinal products) to meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations leading to commercialization. Essential Duties & Responsibilities: Responsible for the QA Product Release team, the QA Material Release team, and the QA Validation team. Responsible for clinical batch Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition. Responsible for raw material release and disposition for all class of materials received at ProKidney for GMP purposes. Responsible for the QA review of all GMP equipment and Facilities upgrades that the QA Validation team performs for all GMP equipment and Facilities. Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions. Non-conformance/CAPA Management support. Review and approve non- conformance reports specifically associated with GMP manufacturing Mentor investigators and approvers on the investigation process and technical writing. Ensure compliance with current S. and EU cGMP regulations and industry standards. Provide leadership to both Quality and Manufacturing staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction. Provide input for continuous improvement company quality systems related to GMP manufacturing. Identify product quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner. Perform risk assessments of new programs for entry into the GMP Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends. Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role. Provide strategies to address GMP manufacturing compliance gaps or determine enhancements to cross-functional quality systems. Ensures quality staff assesses and approves change controls associated with GMP manufacturing. Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels. Establish, educate, and enforce standard operating procedures required under Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions related to GMP manufacturing Identify performance or compliance gaps and implement or propose solutions; solve complex problems of a technical nature. Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical supply

Requirements

Quality GMP operational experience implementing and overseeing investigational drug manufacture and aseptic processing operations in a manufacturing facility.
Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required.
Demonstrated experience building and leading exceptional GMP Quality Assurance teams.
Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products.
Strong knowledge of current industry trends and the ability to use the latest Working knowledge of aseptic practices and clean room design/operations, auditing techniques.
Strong leadership skills with the ability to thrive in a high throughput Ability to lead and manage projects/teams within corporate objectives and project
Successful in mentoring people Collaboration / Teamwork / Conflict Management
Bachelor’s degree in a scientific or allied health field with 10+ years of relevant work experience, or relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing

Nice To Haves

Biologic or cell therapy manufacturing and/or analytical
A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include quality assurance of GMP operations, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment, or facilities management.
Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
Ability to identify, focus, and solve problems in a timely and efficient Experience with quality audits and EU regulatory
Experience or working knowledge of R&D or clinical supply areas and

Responsibilities

Responsible for the QA Product Release team, the QA Material Release team, and the QA Validation team.
Responsible for clinical batch Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition.
Responsible for raw material release and disposition for all class of materials received at ProKidney for GMP purposes.
Responsible for the QA review of all GMP equipment and Facilities upgrades that the QA Validation team performs for all GMP equipment and Facilities.
Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
Non-conformance/CAPA Management support.
Review and approve non- conformance reports specifically associated with GMP manufacturing Mentor investigators and approvers on the investigation process and technical writing.
Ensure compliance with current S. and EU cGMP regulations and industry standards.
Provide leadership to both Quality and Manufacturing staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction.
Provide input for continuous improvement company quality systems related to GMP manufacturing.
Identify product quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner.
Perform risk assessments of new programs for entry into the GMP Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends.
Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role.
Provide strategies to address GMP manufacturing compliance gaps or determine enhancements to cross-functional quality systems.
Ensures quality staff assesses and approves change controls associated with GMP manufacturing.
Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
Establish, educate, and enforce standard operating procedures required under Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions related to GMP manufacturing Identify performance or compliance gaps and implement or propose solutions; solve complex problems of a technical nature.
Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical supply