Agile Scrum Master Pharma & GxP Compliance

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients.

‘Take your Career
to a new Level’

PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting.

Employee Value
Proposition

The Scrum Master facilitates Agile Scrum processes within
cross-functional teams responsible for software development, digital
transformation, or process improvement projects. This role ensures Agile
practices are effectively applied while maintaining compliance with regulatory
requirements such as FDA, GxP, and 21 CFR Part 11, supporting the delivery of
high-quality, compliant solutions.

This role supports validation, regulatory compliance, and
continuous improvement initiatives critical to Good Manufacturing Practices
(GMP).

Requirements

Role Functions:

• Facilitate Scrum
  Events: Lead daily stand-ups, sprint planning, sprint reviews, and
  retrospectives with pharmaceutical project teams.
  
• Agile Coaching: Guide teams and stakeholders on Agile principles and Scrum framework tailored
  to regulated environments.
  
• Impediment
  Removal: Identify and resolve blockers that impact team productivity while
  ensuring compliance with pharmaceutical regulations.
  
• Support Product
  Owner: Collaborate with Product Owners to maintain a prioritized and
  compliant product backlog aligned with business and regulatory needs.
  
• Promote
  Collaboration: Foster effective communication and collaboration among
  cross-functional teams including Quality, Regulatory, IT, and Operations.
  
• Monitor &
  Report: Track sprint progress, team velocity, and deliverables; provide
  transparent reporting to stakeholders and leadership.
  
• Continuous
  Improvement: Encourage teams to reflect on processes and implement
  improvements that enhance quality, compliance, and efficiency.
  
• Risk &
  Compliance Awareness: Ensure Agile practices align with pharmaceutical
  industry standards, risk management, and documentation requirements.
  
• Stakeholder
  Engagement: Facilitate communication between technical teams and regulatory
  or quality assurance groups to ensure alignment.
  
• Facilitating the sprint planning meeting for all sprint
  teams.
  
• Facilitating the daily scrum for all sprint teams.
  
• Working with sprint teams and Emerson to schedule the
  various meetings (demo, redemo, discussions, etc).
  
• Reviewing the planner and working with sprint teams to
  get the status of the tasks in planner updated
  
• Removing the sprint team's impediments on day to day
  basis.
  
• Giving the support sprint teams need for the project
  execution.
  
• Resolve the queries raised by sprint teams.
  
• Facilitating discussions of sprint teams with people
  outside the sprint team.
  
• Working with sprint teams to ensure attendance is
  updated.
  
• Highlighting risks and issues with the leadership team.
  
• Discussing the vacation plans of sprint team members with
  required people, analyse the impact, work on mitigation and share with the
  leadership team .
  
• Reporting.
  
• Updating the teams progress and share in tier meetings .
  
• Update the metrics for tier meeting.s
  
• Discussions with Emerson on project execution.
  
• Weekly call with Emerson.
  
• Updating the sprint data in planner.
  
• Working with the area leads to ensure planner is updated.
  
• Sharing the challenges faced by sprint teams with Emerson
  and work on the mitigation or resolution.
  
• Facilitate retrospective sessions and record the next
  steps identified in these sessions, and work on them.
  
• Facilitating and preparing the slides for weekly sprint
  progress meeting.
  
• Giving sprint updates in Tier meetings.
  
• Ensure Automation compliance with Global Policies,
  Procedures and Guidelines, regulatory requirements and execute current Good
  manufacturing Practices (cGMP) in the performance of day to day activities and
  all applicable job functions.
  

Knowledge, Skills
& Education:

• Bachelor’s degree in Information Technology, Computer
  Science, Engineering, or related field preferred.
  
• Proven experience managing and supporting digital
  systems, software platforms, or industrial control systems.
  
• Strong technical knowledge of system integration,
  networking, databases, and cybersecurity principles.
  
• Proficiency with relevant digital tools and platforms
  specific to the industry (e.g., SCADA, MES, ERP, cloud services).
  
• Excellent problem-solving, communication, and project
  management skills.
  
• Ability to work collaboratively across departments and
  with external partners.
  
• Relevant certifications (e.g., PMP, ITIL, cybersecurity
  certifications) are a plus.