Back to jobs

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

Remote

 

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.
 
To review our privacy policy, click here

 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...
Select...
Select...
Please select the GXP computer systems you have prior experience with *
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Apogee Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.