Compliance Product Manager, Revvity Signals Software

Overview:

We are looking for a Compliance Product Manager, Revvity Signals Software experienced product leader who can drive compliance-related functional capabilities and procedural methodologies in the Signals Software portfolio. This is a terrific opportunity for someone who understands the procedural and compliance related needs of software serving regulated laboratory environments, including pharmaceutical development and preclinical and clinical testing. The candidate must have a strong understanding of software requirements for GxP laboratories, with experience as to how practices have evolved to meeting the demands of agile SDLC of SaaS offerings. The person taking on this role must be a willing and adept challenger of the status quo, in their ability to drive common-sense approaches to the classic problems of software validation and compliance with modern state-of-the-art SaaS solutions delivered with fast-paced agile development and delivery. This is a primarily remote position with minimal travel requirements (approximately four times per year).

Specific responsibilities include:

• Define functional requirements in the Signals Platform for customers using the software in GxP areas
• Drive procedural and documentation deliverables to support customer Validation and Compliance

For both of the above (functional and procedural):

• Conceptualize, manage, and drive the roadmap in collaboration with R&D, Design, Compliance, QA, and other supporting functions
• Act as the key thought leader for customer change management of compliance/validation in an agile/SaaS world
• Act as a key participant in customer audits, and in many cases defining, communicating, and driving CAPAs (Corrective and Preventative Actions)
• Create crisp and clear requirements documentation for new ideas and enhancements
• Create, maintain and assume accountability for a culture of high customer service
• Play a hands-on role throughout the development cycle to demonstrate value of product to customer
• Evangelize – both internally and externally – the product offerings
• Deliver engaging, informative and well-organized presentations, as needed
• Drive portfolio into more regulated areas (e.g. pharmaceutical development, preclinical and clinical testing, government)

Release Management

• Drive and oversee SaaS platform release process, coordinating across product managers and functions

Basic Qualifications:

• Bachelor's Degree AND experience with the “alphabet soup” of concepts of software for regulated areas (e.g. 21CFR11, GAMP 5 V2, IQ/OQ/PQ, HIPAA) and software development expertise
• A minimum of 8 years of relevant experience in building or using enterprise software solutions

Preferred Qualifications:

• BSc in Computer Science or related field
• PhD in a scientific discipline with subsequent software development expertise
• Sound understanding of software product life cycle management
• Experience in end-to-end execution of product launch marketing strategies
• Experience and understanding with laboratory workflows or scientific applications preferred
• Demonstrated requirements analysis & documentation experience
• Good understanding of regulatory audits, how they affect our customers and how they affect us to provide the required features, evidence, and documentation from a product perspective
• Solid understanding of how agile Epics and User stories must be written so they are accepted as a replacement for heavy-duty functional and design specifications

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