Manager, Quality Assurance Validation

Kriya Therapeutics • Morrisville, NC

54d

About The Position

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal's Life Sciences 2024 "Best Private Company to Work For," recognized by Forbes as one of "America's Best Startup Employers of 2024," and honored as one of BioSpace's "2025 Best Places to Work." Role Overview The Manager, Quality Assurance Validation plays a critical role in ensuring the integrity, compliance, and reliability of equipment, methods, processes, and computerized systems within the GMP environment. This position provides support and quality assurance guidance to the Technical Operation's department ensuring that the lifecycle of the validation program follows all regulatory requirements. In this role, you will use your knowledge to ensure site validation activities align with Kriya's Validation Policy, Site Validation Master Plan, and applicable Quality Systems.

Requirements

• 5+ years of industry experience.
• Minimum - Bachelor's or Masters's degree preferably in an Engineering, Science, Technical, or related fields.
• Minimum of three (3) years of experience in Quality Assurance and Validation within the biotechnology workforce.
• Thorough knowledge of applicable regulations and standards related to validation activities
• Experience working in a cGMP environment
• Detailed knowledge of GAMP 5 applications and CSA approach.
• Proficiency in Microsoft Suite
• Ability to manage daily work activities of this role with minimal supervision
• Strong orientation for quality and cGMPs
• Strong collaborative skills
• Highly self-motivated and detail oriented
• Demonstrated level of respect for individuals
• High level of integrity and personal responsibility

Nice To Haves

• Relevant certifications such as CQA are preferred.

Responsibilities

• Collaborate with cross-functional teams to develop and execute a robust validation strategy for equipment, utilities, and computer software assurance (CSA), that align with regulatory requirements.
• Work with various departments to define the validation scope, deliverables, and timelines.
• Review and approve validation documents including SOPs, protocols, specifications, test scripts, acceptance criteria, and reports.
• Ensure implementation, operation, and validation of GXP computerized systems follow GAMP 5 guidelines.
• Participate in risk assessments related to GXP equipment, utilities, and computerized systems.
• Identify and address potential risks to data integrity, security, and safety.
• Provide quality support for change control processes and activities that occur for any modifications to existing or new systems, equipment, instruments, or utilities to ensure validation requirements are assessed and fulfilled.
• Review/approve validation exception records and investigations.
• Opportunity to participate in CSV vendor audits.
• Support biennial reviews of validated systems as required.
• Provide various quality support in other areas of Quality that include batch record review, data review, material release, vendor and regulatory audits, SOP review, and other document reviews, as needed.

Benefits

• Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 101-250 employees