Validation Project Manager

Customer Services · Boston, Massachusetts
Department Customer Services
Employment Type Full-Time
Minimum Experience Mid-level

WHO WE ARE


Boston Technology Research (BTR) is a regulatory technology company serving healthcare, life sciences and SaMD. We provide enterprise-wide solutions that automate how companies ensure compliance with domestic and international regulatory requirements. BTR is headquartered in Chelsea, MA with a global workforce located throughout North America, Europe and Asia.


BTR’s mission is to help Healthcare improve the lives of patients by making it easier for the industry to adopt cutting-edge technologies.  Over the next 10 years, the research being done today will turn into therapies that will revolutionize how we treat cancer and other illnesses.  We are doing our part to help these innovations get to patients quicker, and safer. Combining automation with deep regulatory expertise, our software ensures the technologies used to bring new products to market meet the requirements of the FDA and global health authorities.


BTR was founded by a team of who have been at the forefront of Life Sciences software for almost 20 years.  We have helped over 250 companies transform how they research, manufacture, and monitor the safety of their therapies.


We’re looking for a Validation Project Manager to facilitate validation projects and provide expertise for BTR’s healthcare and pharmaceutical clients. Help transform the way IT and Validation teams manage their validated systems.  The Validation Project Manager will work closely with cross-functional teams to ensure project delivery. The Validation Project Manager will also be responsible for managing validation for customer implementations, ongoing release management, coordinating with stakeholders, and being the expert in industry best practices.


If you have a passion for helping customers improve their process for validation, and driving change we want to hear from you. 


OUR VALUES


Do the Right Thing.  A shared purpose and values, guided by integrity, with the interest of all stakeholders in focus.  Our #1 value in every single decision.


Clear and Transparent. Direct, concise, and open communication builds trust and improves accountability.


Always Add Value.  We are dedicated to being a company where everyone has the motivation and support to improve. 


WHO YOU ARE


  • 4-5 years’ experience with computer systems/software used in Life Sciences
  • 2-3 years’ experience in Project Management
  • Demonstrated knowledge and experience in validation of GxP systems
  • Experience with SDLC, software development, systems architecture, and interfaces/reporting
  • Demonstrated knowledge and experience in current technologies and platforms including project management tools
  • Understanding of FDA regulations and industry best practices including 21 CFR Part 11 and principles of computer systems validation
  • Knowledge of agile software development and software testing methodologies
  • Knowledge of Veeva Vault and Laboratory software is highly preferred
  • Knowledge in Documentation Life Cycle and Good Documentation Practices
  • Excellent communication (verbal and written), leadership skills, teamwork, and organizational skills
  • Ability to work independently and coordinate with cross-functional teams to ensure timely project delivery
  • Highly motivated, proficient in writing and communication skills, and ability to give high attention to detail
  • Exhibit good negotiation and problem-solving skills


RESPONSIBILITIES


  • Coordinate, direct, and lead validation projects. Manage customer implementation validation of software systems and change management
  • Develop Project Plans and adhere to them to ensure timely delivery
  • Interface with client stakeholders, maintain the project timelines and budget
  • Provide subject matter expertise and assist with business development efforts
  • Develop computer system validation strategies according to GAMP 5
  • Demonstrate understanding of FDA validation guidelines and industry best practices
  • If needed, author, review, and complete validation documentation as required (Plans, Traceability Matrix, URS, IQ/OQ/PQ protocols, Test Scripts and summary reports)
  • Communicate with management to represent Quality/Validation in projects and ensure that project quality objectives are met
  • Coordinate with customer stakeholders to ensure project success
  • Work on multiple projects simultaneously
  • Analyze customer documentation to ensure compliance with industry regulations
  • Ability to detect any possible issues in advance and define possible mitigation actions per time, in collaboration with teams
  • Complies with company’s policies and procedures


NICE TO HAVES


  • Experience working with Veeva Vault and Laboratory software
  • Experience in consulting and service environment
  • Proficient in project management software


We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Thank You

Your application was submitted successfully.

  • Location
    Boston, Massachusetts
  • Department
    Customer Services
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level