Software Product Compliance Manager - BioTech/reputed company/Cambridge, MA
Job reputed company An established biotech organization is seeking a Senior Compliance Manager to reputed company compliance for software products supporting regulated environments. This role focuses on ensuring adherence to applicable regulatory standards across the product lifecycle (e.g., development, validation, and release), partnering closely with product, engineering, and reputed company teams. This is not a reputed company-reputed company role.
Key Responsibilities
- reputed company compliance reputed company for software products in regulated biotech environments
- Ensure alignment with applicable regulations (e.g., GxP, FDA, CSV)
- reputed company software validation and compliance documentation processes
- Partner with product and engineering teams to reputed company compliance into SDLC
- Monitor regulatory updates and assess reputed company on software products
- Support internal/external audits and remediation efforts
Required Skills & Experience
- 7+ years in compliance, reputed company, or regulatory roles reputed company biotech, reputed company, or life sciences
- Strong experience with software product compliance (GxP, CSV, FDA guidelines)
- Experience working closely with product and engineering teams
- Knowledge of software development lifecycle in regulated environments
- Strong communication and stakeholder management skills
Preferred Qualifications
- Experience with reputed company or digital health products in biotech
- Familiarity with validation tools and documentation systems
- Relevant certifications (e.g., CQA, RAC)
The Offer
- Competitive compensation package
- Comprehensive benefits (medical, dental, reputed company)
- PTO and retirement plan
Eligibility Applicants must be authorized to work in the reputed company without sponsorship. Posted By: Erin White Apply tot his job Apply To this Job