Position SummaryThe Sr. Manager of Validation will lead ProKidney's on-site Validation team, serving as both a people leader and a hands-on technical contributor. In this role, you'll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation documentation - including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs - in accordance with GAMP 5, 21 CFR Part 11, and FDA's Computer Software Assurance guidance.
Responsibilities- Provide leadership and direction to Validation team members, driving performance and value creation aligned with site operational and strategic goals
- Ensure adequate resourcing (capacity and capability) to accomplish site objectives; identify and recommend solutions to alleviate constraints in partnership with the Director of Validation
- Regularly interacts with cross-functional department leaders on multi-department projects and challenges; supports change initiatives led by senior leadership
- Actively contribute to and continuously improve the culture of the Validation team and the broader site
- Supports Validation representation during GMP and other regulatory agency inspections (FDA, CDC, OSHA, etc.) under the direction of the Director of Validation
- Identify areas to improve project delivery efficiency and reduce operational costs; bring forward recommendations and support implementation of approved investment strategies
- Hands-on troubleshooting and problem solving at the Gemba in support of Validation team members and operations
- Develop and lead small to medium-sized continuous improvement projects; remain actively involved in projects led by staff members
- Effectively delegate work and build confidence and competence within direct reports through coaching and mentorship
- Drive engagement in the technical and personal development of Validation team members
- Develop strong cross-functional relationships with partners (QA, Manufacturing, Engineering, etc.) and model collaborative behaviors for all team members
- Provide effective cross-functional leadership to support delivery of site objectives in alignment with the site validation strategy
Qualifications- Bachelor's degree. Preferred Fields of Study: Life Sciences or Engineering
- A minimum of 7 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role
- Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)
- Strong understanding of Validation Lifecycle (GAMP 5) principles
- Experience with calibration and maintenance management software
- Knowledge of electronic document management systems
- Experience with data integrity practices and compliance
- Strong technical writing skills for qualification documents, SOPs, and work instructions
- Ability to manage multiple projects simultaneously with minimal supervision
- Detail-oriented with excellent verbal and written communication abilities
- Ability to adapt to changing priorities in a deadline-oriented environment
- Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.
- Knowledge of pharmaceutical equipment, such as centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.
- Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
- Experience in writing computer system test scripts, validation protocols and summary reports
