Life Sciences Consultant

2 weeks ago

Dallas, Texas, United States BIP US Full time
Consultant for Life Science Industries

BIP US is seeking a Consultant for Life Science Industries to join our Midwest/Northeast consulting team. As a key member of our team, you will be responsible for enhancing the processes and workflows of our large life sciences client to support an increasingly global product footprint.

You will work closely with internal, client, and vendor team members to identify opportunities for improvement both globally and regionally based on business and regulatory need. Your role will involve enhancing or developing content packages and managing them through the corporate approval process.

Key Responsibilities:

  • Assess the impact of procedural document creation or updates on other procedural documents.
  • Engage with stakeholders/SMEs and ensure their involvement in content development/revision activities, including review and approval cycles.
  • Translate complex cross-functional concepts to process maps.
  • Address deviations, inspection commitments, corrective/preventative actions, and other gaps.
  • Facilitate process mapping activities, capturing process details (scope, boundaries, inputs, outputs, process steps, and sequence, and process visualization).
  • Collaborate with Quality Managers to ensure alignment with Content Standards and Lean Writing Principles.
  • Manage document review and approval workflows.
  • Maintain project schedules, identifying and mitigating risks or issues and escalating with recommendations as needed.
  • Coordinate approval with business units and Quality.

**Requirements:**

  • Minimum 5-10 years in an external client-facing role as a Consultant or other relevant experience.
  • Industry and/or consulting experience in Global Pharma or Biotech.
  • Ability to understand and discuss complex information with people of diverse occupational backgrounds.
  • Experience in controlled procedural document principles, process design, and leading process improvements.
  • Design/development of SOPs, supporting documents, and forms/templates.
  • Ability to understand and translate complex processes into lean processes.
  • Ability to write in explanatory and procedural styles for multiple audiences.
  • Awareness of GxP regulatory requirements.
  • Strong leadership, organizational, and project management skills.
  • Bachelor's degree in engineering, business, or a related field. An MBA or advanced degree is preferred.

**Benefits:**

  • Choice of medical, dental, vision insurance.
  • Voluntary benefits.
  • Short- and long-term disability.
  • HSA and FSAs.
  • Matching 401k.
  • Discretionary performance bonus.
  • Employee referral bonus.
  • Employee assistance program.
  • 9 public holidays.
  • 22 days PTO.
  • PTO buy and sell program.
  • Volunteer days.
  • Paid parental leave.
  • Remote work environment with ability to travel to office as needed.

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