Associate Director, Quality Validation

The Associate Director of Quality Validation is an integral part of the overall ProKidney Quality team, contributing to our success by being responsible for the Quality oversight and collaboration with all Qualification and Validation objectives associated with ProKidney’s GMP Manufacturing facilities, equipment, systems, and product manufacturing processes.

The complexity of the work demands strong technical background across a variety of scientific disciplines and fundamentals regarding the engineering/mechanical operation of facility utilities, environmentally controlled areas, equipment, and control systems used in GMP manufacturing. Required for this position is also experience with process technical transfer which includes manufacturing process technologies and biopharmaceutical best practices. The incumbent will work closely with technical/management representatives from other ProKidney functional organizations that will be responsible for executing the work being done.

The Quality ValidationAssociate Director position requires an experienced people manager, with technical knowledge of pharmaceutical aseptic filling operations and equipment. In addition, the candidate will be responsible for leadership of highly complex compliance projects and initiatives such as New Product Introduction and Cleaning Validation Program. These projects require close collaboration with Manufacturing, Engineering, and Facilities, as well as other technical and operational departments. This candidate will sit on the technology validation cross functional teams associated with qualification and validation projects. This is an on-site position.

The Quality ValidationAssociate Director has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System (QMS). The Associate Director of Quality Validation is responsible for ensuring that equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any re-validation studies are performed.

Essential Duties & Responsibilities:

• Responsible for crafting, maintaining and continually improving the validation system in line with current FDA and international standards.
• Responsible for implementation and ongoing improvement of validation policies and procedures within the company Quality Management System, along with providing technical expertise within those functional areas.
• Responsible for developing and implementing matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Responsible for oversight and execution of validations for production, manufacturing and cleaning processes.
• Designs, authors, and aids in the execution of validation protocols.
• Authors process validation protocols and report, along with developing and maintaining validation metrics.
• Responsible for ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities, and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards.
• Developing a strong documentation package, involving form conceptual study to various phases of qualification like IQ, OQ, DOE trials and performance Qualification of equipment, Facilities and Utilities.
• Responsible for timely completion of projects to meet the company objectives.
• Responsible for qualification and documentation related to validation department.
• Responsible for workload forecasting and ensuring effective work processes& procedures are in place and are being followed / used by all the team members.
• Conduct regular project review meetings within the team, with cross-functional teams and with the vendors to control the project time to time.
• Should have hands on experience in conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.
• Working experience in reviewing/development of URS, FAT, SAT, commissioning, qualification and validation.
• Ability to work in a team structure; plan, organize and prioritize work.
• Ability to analyze quantitative data, create and/or edit written reports and be able to process information.
• Supports the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches.
• Manage the research of new manufacturing technologies to further fine-tune technology transfer activities and overall process improvement
• Initiate change control in system and ensure approval and closure
• Coordinate Trial, Engineering, Clinical and Regulatory Batches according to defined protocol
• Write Manufacturing Process Transfer Plan/Report including check list for equipment, process, materials, components, among others.
• Author experimental design, tech transfer reports, and development reports.
• Author manufacturing batch records and SOPs for new processes and equipment.
• Product transfer (scale-up)
• Support Business Dev and Project Management for transfer to commercial site
• Assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes.
• Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results

Education And Experience:

• Bachelor of Science in Biology, Chemistry, Engineering, Biochemistry, or related life science required
• 5+ years of experience in pharmaceutical or biopharmaceutical manufacturing with strong knowledge on GMP/cGMP and FDA regulations in the Pharmaceutical Industry required
• Detail oriented with strong written and verbal communication skills. Requires proficient presentation and technical writing abilities
• Diverse and demonstrated technical knowledge with strong risk management mindset
• Ability to work independently, within prescribed guidelines, or as a team member
• Computer skills (MS Office, MS Word/Excel, Visio, MS Project)
• Knowledge of cGMPs regulations
• Ability to make sound decisions about scheduling, allocation of resources, and balancing priorities