Director, Computer System Validation - Quality Assurance (CSV QA)

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.

If this sounds like you, keep reading!

Role Summary

We are seeking a Director of Computer System Validation (CSV) Quality Assurance (QA) to join Apogee to provide strategic leadership and oversight of validation of GXP computer systems and software used in compliance with regulatory standards. This role will drive the development, execution, and continuous improvement of CSV and Computer Software Assurance (CSA) processes, verifying the systems are validated, maintained, and compliant to meet business needs and regulatory requirements.

Key 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.
  
  

Ideal Candidate

• Bachelor’s degree in computer science, life sciences, engineering, or related field. Advanced degree is preferred.
• 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.
• 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 preferred.
• Proven ability to lead high-performing teams in a fast-paced environment, with a deep understanding of the SDLC, system validation methodologies, and risk management practices.
• 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.
  
  

Other Requirements

• Position requires up to 20% travel to department and company meetings.
  
  

The anticipated salary range for candidates for this role will be $200,000 - $225,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

What We Offer

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• 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
  
  

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.