Principal Specialist, QC Project Management, Fremont CA

Compensation Details

The base salary range for this position is $128,000 to $192,000. The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, qualifications, and other factors permitted by law. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored benefits. For additional information regarding our benefits and Total Rewards offerings, please click here.

Description

Duties & Responsibilities

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  Define work packages according to the project scope working with the CMC Project Leader. Acts as the primary QC member during the project phase for the external clients or BI IU team coordinating the flow of information from and to the client.
  


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  Lead the analytical sub-team for individual projects through guidance on the contractual situation (CROs) as needed. Ensuring appropriate flow of information within the QC department including project updates at regular intervals. Informs the cross functional project teams on important decisions in a timely manner to support the project.
  


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  Support the implementation of standards for QC project work at BI Fremont such as setting of specifications, sampling plans, analytical comparabilities, method transfer and validation, reference material characterization and release and stability analytics. Constant monitoring and continuously improving of critical processes.
  


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  Contribute to definition of BI standards and processes on a global level and ensure local implementation. Lead or contribute to change management initiatives on a local and on global level.
  


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  Local MSO for key processes (OOX and stability process).
  


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  Responsible for the outsourcing of project analytics, review of data from contract labs.
  


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  Project Management Systems and Execution.
  


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  Support the establishment of appropriate project management systems, steering mechanisms and tools (plans, dashboards, reports) to generate, update and monitor work packages and project plans (including milestones and decision points) consistently.
  


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  Work in a highly regulated area (FDA, EMA, ICH, EP, USP, CFR). Expert understanding and interpreting the applicable guidelines. Accountable for representing BI policies in government inspections, client audits, client negotiations, project specific events such as client meetings and in the project acquisition phase.
  

Requirements

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  Bachelor’s Degree from an accredited institution in Science (e.g. Biology, Chemistry, Biotech, Pharmaceutical Sciences or equivalent) with at least seven (7) years’ experience in the pharmaceutical industry
  


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  Master’s Degree from an accredited with at least five (5) years’ experience or a PhD from an accredited institution with at least two (2) years’ experience in the pharmaceutical industry will also be considered
  


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  Sound knowledge of biopharmaceutical production processes
  


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  Prior experience working on global team is required.
  


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  Project Management skills and project management systems required.
  


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  Ability to interact and gain support of senior management.
  


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  Good problem-solving capabilities and experience working with customer business.
  


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  Intrapreneurship and decision-making.
  


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  Open to changes and constant improvement.
  


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  Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management.
  


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  Skilled in strategic thinking, communication and negotiation fast decision-making to ensure the daily business.
  


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  Excellent leadership, communication and collaboration skills in a cross-functional, global, and fast paced environment.
  


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  Analytical expertise focusing on key analytical technologies used in Biopharma.
  


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  Experience in biopharmaceutical product development and/or method development.
  


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  Strong professional presentations experience with the ability to present data to and key stakeholders.
  


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  Experience with Quality Systems such as Deviation, CAPA, Change Control Systems and investigations processes desirable.
  


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  Ability to work in cross-functional teams and provide the leadership to implement solutions to complex problems within analytics using Project Management expertise.
  


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  Agility to contribute in the development of a new organization, building efficiencies with the ability to build strong trusting relationships and build credibility quickly.
  


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  Strong Strategic thinking ability and business judgment.
  


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  Ability to resolve conflicts with team members and cross functionally.
  


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  Excellent communication skills with the ability to build rapport with management and employees and contribute to all aspects of an organization.