Compliance Manager

This is senior position in Rosetta Biosoftware's Quality Management & Operations department.  The position will spearhead Rosetta Biosoftware's efforts to develop an organization that can effectively market software and services to support the FDA pre-market submission and post-market surveillance efforts of our customers and partners.

Description of Duties and Responsibilities

Under the direction of the Director, Quality Management & Operations, the Compliance Manager will carry out the following duties:

• Manage Rosetta Biosoftware's quality management system, including the organization's Policy Manual and related procedures.  
• Ensure Rosetta Biosoftware's quality management system and business processes comply with applicable government regulations and industry standards.
• Monitor internal controls of key business processes, and their supporting applications and infrastructure, to measure effectiveness and mitigate risk.
• Collaborate with policy and procedure owners to write, review, and update their documents.
• Work with Rosetta human resources to record staff training on policies and SOPs.
• Coordinate a consistent approach to writing requirements, design specifications, test cases, and other project documentation across multiple product groups.
• Help organize and maintain content of compliance-supporting systems, including systems for requirements management, source code control, and change management.
• Review project deliverables to ensure compliance with approved development methodology.
• Provide input on product features and functionality that will best support the compliance of Rosetta Biosoftware's customers.
• Conduct internal audits of the organization's quality management system and business processes.
• Respond to compliance-related questionnaires submitted by customers and partners.
• Host external audits; answer auditor questions about the organization's quality management system; and facilitate interviews between auditors and other Rosetta Biosoftware staff.
• Work with Rosetta Biosoftware senior management to determine how to best position Rosetta Biosoftware's products in regulated environments.

Qualifications and Competencies

• A bachelor's degree in a related field.  A master's degree is preferred.
• Minimum of 2 to 5 years pharmaceutical, healthcare or legal experience, with some responsibilities related to regulatory compliance and/or auditing.
• Previous involvement with the Food and Drug Administration's (FDA's) regulations and guidance pertaining to electronic records, diagnostic devices, GMP, GAMP, PGx submissions, post-marketing surveillance, and software validation is highly desired.
• Knowledge of software standards, such as ISO 9001, is also desired.
• Excellent written and verbal communication skills.
• Effective time management skills; ability to handle multiple projects simultaneously.
• Demonstrated strong interpersonal skills; must be able to interact confidentially with employees at all levels of the organization.
• Proficient with standard office computer applications.
• Ability to provide classroom, 1-on-1, and online training.
• Ability to give pointed, yet constructive criticism.
• Detail oriented.
• Willingness to take initiative, be self-directed, and work in a fast-paced environment under minimal supervision.

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