I work for a large biotech's regulatory department, and my job is to ensure we remain compliant with federal regulations vis a vis software development.

I want to underscore something that electroniceric touched upon: You work in a regulated industry, and your firm's practices are not compliant with federal regulations.

Your biotech firm's lack of SOPs and BPs on software development is in direct violation of the Code of Federal Regulations. If the FDA audits your firm and finds this lack of compliance to 21CFR820, then the FDA can issue a Warning Letter, which will absolutely have an adverse effect on the company. Warning letters always hurt the company's stock price; investors take WLs as a sign that the company is being mismanaged.

If your CEO doesn't want to believe this, then he or she shouldn't be in that position.

FYI, here's one example of a medical device company that received a warning letter from FDA for failure to properly document software development:

http://www.fda.gov/foi/warning_letters/s6752c.htm [fda.gov]

But Warning Letters aren't the worst thing that FDA can do. For failing to follow CFRs, FDA can determine that drug products (small and large molecule) or med devices are misbranded or adulterated and can demand the company recall said products. This will destroy a start-up or small company....

Good luck with this issue.