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IT Project Manager - GMP Manufacturing (Contract)

Employer
bluebird bio
Location
Durham, NC, United States
Start date
Dec 11, 2018

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Discipline
Information Technology, Project/Program Management, Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Contract
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Job Details

IT Project Manager - GMP Manufacturing
Contract

bluebird bio is seeking a seasoned IT Project Manager with a strong background in the GMP Manufacturing area. The IT Project Manager will lead and manage software implementation projects related to business and systems initiatives. This role will work closely with all internal groups and external third-party service providers to establish project plans which consider critical tasks, durations and dependencies. The Project Manager is expected to be autonomous in management of meetings, solicitation of agendas, distribution of meeting minutes, tracking completion of action items and regular updates on project status.

About the role:


  • Effectively manage projects using project management best practices and following required Systems Development Life Cycle (SDLC) policies
  • Elicit requirements using interviews and workshops, document analysis and business process descriptions, use cases, scenarios, business analysis, task and workflow analysis
  • Create and distribute documentation as needed: Functional Requirements, Business Requirements, Use Cases and End-to-End testing documents, Data Flow Diagrams
  • Serve as the conduit between the customer community (internal and external customers) and the software development team (external vendors)
  • Perform system unit and integration testing where necessary
  • Ensure appropriate IT processes, procedures, and standards are in place
  • Build and foster effective relationships between the business and IT
  • Oversee vendor relationships
  • Anticipate operational and tactical risks to effectively manage client expectations
  • Coordinate issue resolution with internal and external technical support providers
  • Introduce best practice and process improvement ideas wherever appropriate
  • Ensure adherence to FDA computer systems validation compliance

About you:

  • Bachelors Degree in Computer Science, Information Systems, or a related Science field; Project Management Institute (PMI) / PMP certification a plus
  • Minimum of 5 years of relevant experience within pharmaceutical/biotech industry a must
  • Must have a proven track record to lead a small-to-mid-sized team
  • Experience with enterprise information management systems and software vendor selection
  • Demonstrated ability to manage several complex projects at the same time
  • Experience working with third-party implementers
  • Demonstrated Project Management skills, PMI or equivalent certification preferred
  • Demonstrated ability managing cloud/SaaS based application implementations
  • Domain knowledge of GMP / Manufacturing requirements/guidance/compliance areas (e.g. Process Control Systems / Rockwell SCADA / OSIsoft PI / LIMS / ELN / SDMS / Veeva EDMS & QMS) preferred
  • Strong analytical skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements
  • Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
  • Ability to develop and analyze business requirements and functional specifications for business software solutions
  • Experience in biotech and pharmaceutical industry and best practices
  • Exhibits strong team skills, including facilitating group sessions
  • Ability to multitask - effectively manage simultaneous work requests across Manufacturing, IT, and other organizations
  • Strong work ethic, with a proven track record in successfully achieving goals
  • Strong interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels
  • Self-starter with the ability to work on projects with minimum supervision while adding value to cross-functional teams

Company

bluebird bio is leading the gene therapy revolution. We have nearly 15 years of scientific and clinical experience at the forefront of gene therapy, with deep expertise in rare diseases and immuno-oncology, a proven scientific and lentiviral-based manufacturing platform, and a complementary set of tools such as gene editing.

We are a patient- and purpose-driven, product-oriented organization. Our diverse flock of bluebirds is united by a singular focus: a passionate commitment to changing the lives of patients and supporting each other on this journey. At bluebird bio, we will work like crazy with a never-give-up, little-but-mighty attitude, as exemplified by our namesake, the Eastern Bluebird.

we are always innovating, never stopping and never giving up.

Stock symbol: BLUE

Stock exchange: NASDAQ

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Company info
Website
Phone
339-499-9300
Location
60 Binney St
 Cambridge
MA
02142
US
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