Note: The job is a remote job and is open to candidates in USA. PCI Pharma Services is a company focused on providing life-changing therapies with a global impact. They are seeking a GRC / Technical Controls Analyst to manage their cybersecurity governance, risk, and compliance program, ensuring adherence to pharmaceutical regulatory requirements and supporting audit activities.
Responsibilities
• Develop and maintain cybersecurity policies, standards, and procedures aligned with pharmaceutical regulations
• Manage technical controls auditing across 150+ applications and systems quarterly
• Coordinate GxP computer system validation activities with Quality Assurance team
• Conduct risk assessments for new systems, vendors, and business initiatives
• Maintain compliance evidence and documentation for regulatory audits (FDA, EMA)
• Lead internal security control assessments and gap remediation tracking
• Support third-party/vendor cyber risk management including security questionnaires and assessments
• Develop and track key risk indicators (KRIs) and security metrics
• Coordinate with external auditors and manage audit finding remediation
• Maintain security control framework mapping (NIST CSF, ISO 27001, SOC 2)
• Review and approve security exceptions with appropriate risk documentation
• Support business continuity and disaster recovery compliance requirements
Skills
• Bachelor's degree in Information Security, Risk Management, or related field
• 4+ years of experience in GRC, security compliance, or audit roles
• Strong knowledge of security frameworks (NIST CSF, ISO 27001, CIS Controls)
• Experience with pharmaceutical regulations (21 CFR Part 11, GxP, Annex 11)
• Proficiency in controls testing and evidence collection
• Experience with risk assessment methodologies
• Strong documentation and technical writing skills
• Excellent communication skills for audit and stakeholder interactions
• Project management capabilities for compliance initiatives
• CISA, CRISC, or CGEIT certification
• Direct pharmaceutical or life sciences industry experience
• Experience with GRC platforms (ServiceNow GRC, Archer, OneTrust)
• Knowledge of SOX IT general controls
• HITRUST or healthcare compliance experience
• Experience with vendor risk management programs
Company Overview
• PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market. It was founded in 2012, and is headquartered in Philadelphia, Pennsylvania, USA, with a workforce of 5001-10000 employees. Its website is http://www.pciservices.com.
Company H1B Sponsorship
• PCI Pharma Services has a track record of offering H1B sponsorships, with 1 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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