Sr. Director

The Sr Director of Quality Control will be responsible for leadership of the various functional responsibilities of the Quality Control department, including QC - Operations, QC - Incoming Raw Materials, QC - Systems & Services, and QC – Microbiology Sterility Assurance. The role will lead continuous improvement activities of all quality control systems and drive a continued state of inspection readiness. The leader in this role must ensure that quality documentation and controls are effectively in place for phase III investigational new drugs (investigational medicinal products) to meet all quality requirements and regulatory standards and meet continuous clinical supply and delivery expectations leading to commercialization.

QC – Operations

Routine day-to-day product testing.  This is the main operational component (engine) of QC that supports manufacturing.  Members of this group are experts at running the validated analytical methods.  This group will comprise the largest headcount of personnel.  In time, this group may have to break up into multi-shift work to accommodate the level of product manufacture. 

QC – Incoming Raw Materials

Inspection, testing, and review of associated documentation for all incoming raw materials and components used to support Manufacturing. Members of this group have close associations with purchasing, warehouse, manufacturing, and QA. This group is likely always to remain a single-shift function. 

QC – Systems & Services

Technical support function within QC to support QC Operations and Incoming Raw Materials.  This group is comprised of the following sub-functions:

• Method Technical Transfer
• Test Method Troubleshooting
• Test Method Validation
• Instrument Calibration & Qualification
• Sample Control
• Scheduling
• Stability Program
• QC SOPs Management
• QC Compliance
• Training
• Lab Data (Informatics Systems) & IT Interface
• Lab Data Review & Release
• Interface with Bioanalytical Development

QC – Microbiology Sterility Assurance

Functional testing of sterility of product and assurance of effective and compliant aseptic operations during product manufacturing by execution of ProKidney’s environmental monitoring program.  This group will provide regular feedback to Manufacturing regarding environmental excursions that may occur and information associated with microbials identified to support the corrective actions necessary.  This group will also oversee “Operator Aseptic Qualification” for all Quality and Manufacturing personnel.

Essential Duties & Responsibilities: 

• Directs the development, validation, planning, implementation, and maintenance of QC product tests and analytical methods, processes, and operations.
• Supports the design and execution of the environmental monitoring and sterility assurance programs for GMP manufacturing operations.
• Supports development of QC tests and analytical methods that support production, including design support
• Validates analytical test methods for raw materials and finished goods
• Oversees raw material, in-process and final product release testing.
• Responsible for ensuring the appropriate stability programs are initiated and completed to support product development and customer requirements.
• Ensures quality control systems and equipment are compliant with standards and applicable regulatory guidelines
• Responsible for ensuring that project objectives are met & continuous improvement of the Analytical Laboratories.
• Strong scientific background and experience with cellular therapies across a broad range of cell types and disease treatments (adult-derived cells, stem cells, immune cells. allogeneic, autologous, etc.)
• Familiarity with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH).
• Understanding of analytical method qualification and validation per USP, EP and ICH guidelines.
• Responsible for developing and delivering training materials to ensure that all QC employees’ operational, scientific, and analytical training is conducted as needed to ensure that the group is entirely and accurately trained on time for all QC activities.
• Responsible for liaison with the Manufacturing, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units.
• Provide support in resolving issues to meet project goals and deliverables.
• Serves as primary QC contact for regulatory inspections.
• Leads and participates in projects within the organization’s objectives and project timelines and participates in cross-functional projects as the quality control subject matter expert.
• Hires, manages, and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff, including appropriate training, mentoring, and development of staff.
• Mentor’s direct reports and guide them to the next level in their careers
• Is the primary point of contact and SME for analytical testing and provides guidance aligned with regulatory standards and good laboratory practices.

Secondary Responsibilities and Functions:

• Excellent leadership and networking capabilities to optimize the integration of internal expertise with external resources that include subject matter experts
• Ability to navigate through ambiguity and rapid growth and adapt to change
• Adapts departmental plans and priorities to address resource and operational challenges
• Outstanding communication skills (verbal and written) to collaborate in a dynamic environment
• Natural ability to be organized in how you think, communicate, and conduct your work
• Proven ability to quickly formulate and communicate concise, logical, fact-based information and make recommendations to internal and external stakeholders
• Proficiency in Microsoft Word, PowerPoint, and Excel
• Perform additional duties as assigned

Requirements:

• A bachelor’s degree in biology, biochemistry, immunology, or molecular and cellular biology is required. An advanced degree or Ph.D. in a scientific/technical discipline is preferred.
• 10+ years of experience in GMP regulated biopharmaceutical industry, including 10+ years in a management/leadership role. Advance or Ph.D. degree preferred.
• Technical and regulatory understanding of biologics, gene, or cell therapy QC with an understanding of the control strategy for these drug classes.
• Ability to work in a fast-paced and dynamic environment that will require management of multiple competing priorities while driving all projects forward and meeting program/project deliverables.
• Strong leadership, collaboration, team building, program management and organizational skills.
• Proven ability to develop, communicate, and execute plans and strategies with a wide range of stakeholders.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
• Excellent interpersonal, organizational, and written and oral communication skills.
• Prior experience in a managerial capacity within QA or QC.
• Communicate effectively and successfully handle conflict resolution.
• Possess experience with laboratory operations, analytical transfer and validation, Pre-Approval Inspections, and product launch activities.
• Advanced knowledge of GMPs.
• Experience ensuring all laboratory investigations meet compliance requirements.

Preferred Experience and Skills:

• Extensive experience in a GMP/Professional environment, preferably in biologics.
• Preferred experience in the pharmaceutical industry.
• Prior direct supervisory/manager experience, leading large organization structures.
• Use of Laboratory computer systems
• Potential previous use of GMP Quality Systems such as: MasterContgrol and LIMS
• Prioritization and problem solving.
• Direct, control and plan tasks/projects.
• Excellent communications skills both written and verbal format.
• Relate to others in a team setting. Able to coach and manage experienced and inexperienced staff