Specialist - Computer System ValidationJubilant Pharma, LLC • Montreal, Montreal (administrative region), CA

Specialist - Computer System Validation

Jubilant Pharma, LLC • Montreal, Montreal (administrative region), CA

Il y a 4 jours

Type de contrat

Temps plein

Description de poste

JOB DESCRIPTION

At Jubilant Radiopharma , we’re advancing healthcare through innovation in radiopharmaceuticals. As a Specialist in CSV, IT & Data Governance , you’ll play a critical role in ensuring our digital systems meet the highest standards of regulatory compliance, data integrity, and operational excellence. This is your opportunity to be a trusted SME, lead cross‑functional initiatives, and directly influence regulatory readiness across our IT landscape.

What You’ll Do

Lead CSV & Data Governance Strategy

Own and execute the site-level Computer System Validation (CSV) Master Plan .

Develop and maintain robust policies and SOPs aligned with :

FDA 21 CFR Part 11

Health Canada GUI‑001

EU Annex 11

GAMP5 , PIC / S , and other global regulatory frameworks.

Champion data integrity and governance best practices across the organization.

Drive IT Compliance & Lifecycle Management

Oversee compliance of IT systems and applications , including backup, archival, and user access management.

Lead change control processes and periodic system requalification activities.

Ensure systems remain in a validated state throughout their lifecycle.

Be the SME in Audits & Inspections

Represent Jubilant as the Subject Matter Expert during regulatory inspections and client audits .

Articulate and defend CSV and data governance strategies, policies, and procedures with confidence and clarity.

Collaborate Across Functions

Partner with IT, QA, Engineering, and Supply Chain to ensure seamless integration of compliance into operations.

Coordinate with vendors to ensure third‑party systems meet internal and regulatory expectations.

Lead Risk Assessments & Compliance Reviews

Facilitate and lead 21 CFR Part 11 risk assessments , including SLRA and FLRA.

Support investigations and CAPAs related to IT systems and data compliance.

What You Bring

Bachelor’s or Master’s degree in Computer Science, Biotechnology, IT, or a related field.

5–8 years of hands‑on experience in CSV, IT compliance, and data governance within a regulated pharmaceutical or life sciences environment.

Proven experience supporting regulatory inspections and client audits .

Deep knowledge of global regulatory requirements (FDA, EU, Health Canada, GAMP5, PIC / S).

Strong analytical, documentation, and problem‑solving skills .

Bilingualism (French / English) as the role interacts with regulatory agencies based outside Quebec.

A collaborative mindset with the ability to lead cross‑functional teams and influence without authority.

Why Join Jubilant Radiopharma?

Be part of a mission‑driven organization improving patient outcomes through nuclear medicine.

Work in a high‑impact role with visibility across departments and leadership.

Enjoy a collaborative culture , continuous learning, and opportunities for career growth.

Ready to shape the future of compliance in radiopharma? Apply now and bring your expertise to a team that values innovation, integrity, and excellence.

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Specialist Computer System Validation • Montreal, Montreal (administrative region), CA

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