Sr. Product Manager - Life Sciences Quality Assurance SME

Hamilton Township, NJ
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Type: Direct-Hire

Category: Engineering

Compensation Range: 120000.00 - 140000.00 Yearly

Job ID: 153723

Date Posted: 07/30/2020


SUMMARY
  • Focuses on the development and identification of product requirements based on internal and external client feedback.
  • Focuses on the quality, design, experience and value of current products in the market as well as the next product in development. 
  • Applies domain experience in a creative and innovative manner in order to ensure that the company is building world class products in-line with client, market and government regulations
  • Leads all phases of a product program, from concept through planning, development, go-to-market, launch and post-launch
  • Coordinates with program team members following a structured process and delivering artifacts that must be completed throughout the phases of software development lifecycle
  • Responsible for managing feature enhancements, evaluating the impact of quality on a product and ensure a high quality and satisfying experience for our clients
  • Develop key product themes that are to act as the foundational messaging for marketing and other corporate constituents
  • Perform market studies in order to ascertain and validate the approach of the product/process
  • Leads Product Design Workshops and other forums to solicit feedback, directional guidance, and validation of their product direction using a variety of tools and approaches
  • Responsible for tracking and reporting on updates and proposes updates to regulations which affect life science and medical device companies
QUALIFICATIONS
  • BS degree in a relevant program of study
  • Prior experience working in Pharmaceutical, Biotech, or Medical Device Quality Assurance, with at least 5 years of experience in pre-commercial quality control or assurance (for example: analytical development and support, product development/ technical services).
  • Strong understanding and experience applying GxP quality processes; experience with quality process optimization and “fit for purpose” quality processes across the product lifecycle; experience with KPI, metrics, and data reporting and analytics expectations within the quality space.
  • Strong understanding of current Life Sciences industry regulatory agencies, regulations, standards, guidelines, etc.
  • Knowledgeable about pain points and inefficiencies in current processes and systems.
  • Should be willing to travel <25% for customer meetings and project engagements

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