Director, Computer System Validation - Quality Assurance

Summary

Join Apogee Therapeutics as their Director of Computer System Validation (CSV) Quality Assurance (QA)! This leadership role requires strategic oversight of GXP computer system validation, ensuring compliance with regulatory standards. You will develop and implement CSV strategies, oversee validation activities, and collaborate with cross-functional teams. The ideal candidate possesses a Bachelor's degree (advanced degree preferred), 10+ years of CSV experience (3+ in leadership), and relevant certifications. Apogee offers a competitive compensation and benefits package, including a great culture, flexible PTO, and professional development opportunities.

Requirements

• Bachelor’s degree in computer science, life sciences, engineering, or related field
• Minimum of 10 years of experience in CSV within a biotechnology, pharmaceutical, and/or medical device industry, with at least 3 years of experience in a leadership role focused on quality assurance

Responsibilities

• Lead and manage the CSV QA function, ensuring GXP computer systems are validated in compliance with relevant regulatory requirements
• Develop and implement CSV strategies, policies, and processes to ensure consistent, scalable, and efficient validation across the organization
• Oversee the planning, execution, and documentation of validation activities for new and existing GXP computer systems, ensuring compliance throughout their software development lifecycle (SDLC)
• Collaborate cross functionally with IT, software development, regulatory affairs, and other departments to ensure seamless integration of validated systems into business operations
• Lead efforts to identify, assess, and mitigate risks related to computer systems, ensuring that potential issues are proactively addressed
• Drive improvements in CSV and data integrity processes and methodologies, introducing innovative solutions and best practices, including CSA principles, to enhance efficiency and ensure scalability
• Ensure validation documentation (validation plans, test scripts, reports, risk assessments, etc.) is maintained in compliance with regulatory requirements and company procedures
• Lead root cause analysis and CAPA investigations related to CSV issues, ensuring timely resolution and effective corrective measures
• Support vendor assessments and audits
• Stay current with industry trends, regulatory changes, and emerging technologies to continuously improve the CSV framework and maintain compliance
• Lead CSV audit readiness program
• Serve as a key advisor to senior leadership on CSV matters, risk management, and CSV QA

Preferred Qualifications

• Advanced degree
• Certification in Quality Assurance, Computer System Validation, or related fields (e.g., ASQ, ISPE) and advanced knowledge of risk management framework (e.g., FMEA) and their application in CSV processes, with a strong understanding of CSA principles
• Experience with cloud-based system validation, electronic records management, and data integrity solutions
• Strong leadership, team management, and interpersonal skills, with the ability to inspire and develop a high-performing team
• Exceptional communication and presentation skills, with the ability to engage and influence senior leadership and cross-functional teams
• In depth knowledge of validation tools, project management software, document management systems, and business administration activities
• Ability to manage complex projects and prioritize effectively in a fast-paced environment, dynamic environment
• Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 20% annually

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve