Agile Scrum Master – Pharma & GxP Compliance

Tipperary
Permanent
Full-time

6 days ago
Apply easily

About PSC BiotechWho 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 PropositionEmployees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.Overview: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).Hybrid model:3 days on site mandatory requiredRequirementsRole 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.

PSC Biotech