Director of Compliance (life science) Remote –  # 9538

Director of Compliance (life science) Remote –  # 9538

A life science technology company looking to make the world safer and healthier by accelerating new product development of life-saving medicine and devices for humans and animals is searching for a Director of Compliance.

 Description

The Director of Compliance is responsible for overseeing the compliance function. This role partners with the leadership team, including the CEO, heads of Product Management, Engineering, Operations, and Sales & Marketing, to maintain and grow the compliance program in support of company’s operational goals. The Director of Compliance maintains compliance operations, including overseeing quality processes, procedures, and associated documentation to meet industry regulations such as 21 CFR Part 11, ISO 9001, GDPR, HIPAA, Annex 11, and SOC 2, as well as animal health regulatory requirements from the FDA Center for Veterinary Medicine (CVM), USDA Center for Veterinary Biologics (CVB), EMA/CVMP, AAFCO, and VICH guidelines.

This person brings a blend of IT and quality management knowledge, translates regulatory requirements into product features, operational processes, and actionable guidance, and serves as the primary compliance liaison between company and prospective customers’ QA departments.

 Responsibilities

• Evolve and maintain company’s software validation process, incorporating agile and AI-assisted approaches to development and validation activities.
• Partner with the leadership team (CEO, Product Management, Engineering, Operations, Sales & Marketing) to establish and sustain a culture of compliance throughout software development and infrastructure environments.
• Ensure company’s software and internal processes comply with industry regulatory guidance, including 21 CFR Part 11, Annex 11, ISO 9001, HIPAA, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and animal health regulations from CVM, CVB, EMA/CVMP, AAFCO, and VICH.
• Manage the security compliance program, including SOC 2, HIPAA, and GDPR, using security compliance tools such as Drata.
• Manage all company documents (policies and SOPs) and internal training.
• Create a growth plan for the compliance function, including hiring, new processes, new systems, and cross-team collaborations to support growth goals.
• Perform verification/testing and validation plan development and execution for software products.
• Coordinate internal and external audits, including managing relationships with external auditors and contract auditing firms.
• Respond to customer and sponsor security assessment questionnaires on processes, product(s), and Compliance activities.
• Engage directly with sponsors and CROs on compliance matters, serving as the primary point of contact for quality and security inquiries.
• Oversee non-conformance management (incidents and deviations), including CAPAs and communication with client partners.
• Conduct vendor risk assessments and qualifications to ensure vendors meet the company’s standards across quality and security requirements.
• Translate regulatory requirements into product features, functionalities, and operational realities in collaboration with Product Management, Engineering, and Operations.
• Represent company in the animal health R&D regulatory community and serve as the company’s Regulatory Ambassador.
• Support and coach team members in understanding existing and new regulations.

Requirements

• Bachelor’s degree in life sciences, math, or engineering.
• 10+ years of experience in regulatory/compliance within life sciences.
• Working knowledge of 21 CFR Part 11, Annex 11, ISO 9001, SOC 2, HIPAA, GDPR, GCP, and GLP.
• Experience with eQMS platforms (e.g., DotCompliance or equivalent).
• Experience with security compliance tools (e.g., Drata or equivalent).
• Experience managing vendor risk assessments and qualifications.
• Experience coordinating internal and external audits.
• Experience with computer software validation practices.
• Ability to analyze data and trends to ensure QMS effectiveness and drive informed decision-making.
• Ability to work effectively with no supervision and adapt to changing priorities.

Preferred qualifications include:

• Direct experience in animal health or animal science regulatory environments.
• Familiarity with FDA CVM, USDA CVB, EMA/CVMP, AAFCO, and VICH guidelines.
• Experience with eClinical or clinical data management platforms in a SaaS environment.
• Experience translating regulatory requirements into software product features and operational processes.

If you think you could be the right person for this job, please apply for immediate consideration!