PCI Pharma Services

Manager

• Provide Quality Control oversight of all cGMP testing of raw materials, in process, product release, clean utility and environmental monitoring testing.
• Review and approve all QC related investigations (deviations, OOS/OOT, EM Investigations, etc.) both with internal and external laboratories
• Maintains good relations and communications with clients as a primary technical interface
• Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing personnel
• Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented
• Working with project teams to represent Quality Control, conducting risk assessments and introducing best practices into the Quality Control processes
• Leading customer interaction on all QC related projects including routine testing updates
• Manage and develop professional and technical skills and performance of department members
• Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary
• Supporting regulatory information requests from customers as it pertains to QC.

Quality Control Manager

QA Engineer

• Work with other departments to ensure the quality of products and compliance to internal procedures and external standards
• Provide quality oversight for client facing QA operations, including Batch Record review and final product lot disposition
• Evaluate events, deviation incidences and determine whether to escalate to an investigation
• Conduct Change Control assessments and quality review
• Approve investigations and create/monitor associated CAPAs
• Establish relationships with internal and external customers to address quality matters
• Review, develop, and improve quality system procedures
• Lead improvement projects and communicate status to management
• Manage assigned QA staff, providing feedback and development
• Assist with internal audits and supplier audits as needed
• Interface with clients on documentation and compliance concerns

QA Supervisor, External QA

Engineer

• Lead the enterprise-wide migration from SolarWinds to Dynatrace, including architecture design, agent deployment, and dashboard development
• Design and implement comprehensive monitoring coverage for servers, network devices, applications, databases, and cloud resources across 16 global sites
• Develop custom dashboards, alerts, and automated remediation workflows aligned with operational KPIs
• Establish baseline metrics and anomaly detection rules for proactive incident identification
• Integrate observability platform with ServiceNow for automated incident creation and enrichment
• Configure monitoring for IT/OT environments including manufacturing systems, SCADA, and industrial control systems
• Implement synthetic monitoring for critical business applications and user experience tracking
• Design log aggregation and correlation strategies for security event monitoring in coordination with SECURE team
• Create runbooks and standard operating procedures for alert response and escalation
• Provide 24x7 monitoring strategy and coordinate with global follow-the-sun operations team
• Integrate backup monitoring via Veeam reporting and alerting for RPO/RTO compliance visibility
• Optimize monitoring costs through efficient data retention policies and license management
• Train operations staff on platform usage, dashboard interpretation, and alert response procedures

Observability Engineer

Compliance

• Manage PCI Pharma's cybersecurity governance, risk, and compliance program
• Develop and maintain cybersecurity policies, standards, and procedures
• 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
• Lead internal security control assessments and gap remediation tracking
• Support third-party/vendor cyber risk management
• Develop and track key risk indicators (KRIs) and security metrics
• Coordinate with external auditors and manage audit finding remediation

GRC – Technical Controls Analyst II

Security Analyst

• Monitor security alerts from SIEM, EDR, and other security tools during assigned shifts
• Perform initial triage and classification of security events following established playbooks
• Escalate confirmed incidents to senior analysts with appropriate documentation
• Conduct basic threat intelligence research to support ongoing investigations
• Assist with vulnerability scan execution and results analysis using Nessus
• Support phishing email analysis and user security awareness activities
• Document security incidents, actions taken, and lessons learned
• Maintain security metrics dashboards and operational reports
• Assist with access review campaigns and identity verification processes
• Support security tool administration including rule tuning and false positive reduction
• Participate in tabletop exercises and incident response drills
• Contribute to security awareness training content and delivery

Security Analyst I

Security Engineer

• Serve as the technical security lead for PCI Pharma
• Responsible for security architecture, application security, vulnerability management, and security engineering across enterprise and manufacturing environments
• Combine hands-on technical work with strategic security advisory
• Ensure protection of pharmaceutical intellectual property, patient data, and compliance with industry regulations
• Design and implement security architecture for cloud (Azure, AWS), on-premises, and hybrid environments
• Lead application security program including SAST/DAST integration, secure code reviews, and developer training
• Manage enterprise vulnerability management using Nessus
• Architect and maintain Zero Trust security framework
• Conduct security assessments for new applications and infrastructure changes
• Implement and manage endpoint security solutions

Senior Security Engineer / AppSec Engineer

• Own PCI Pharma's identity and access management (IAM) infrastructure, serving 6,500+ users across 16 global sites
• Design and implement enterprise IAM strategy aligned with Zero Trust architecture principles
• Manage Microsoft Entra ID (Azure AD) including conditional access policies, MFA enforcement, and identity protection
• Administer Active Directory across global domain including GPO management, OU structure, and replication monitoring
• Implement identity governance including access reviews, certification campaigns, and segregation of duties controls
• Automate user lifecycle management through integration with HR systems
• Design and implement Privileged Access Management (PAM) solutions for administrative accounts
• Develop role-based access control (RBAC) models aligned with job functions and least privilege principles
• Configure single sign-on (SSO) and federation for enterprise applications
• Support audit and compliance requirements including SOX, GxP, and 21 CFR Part 11 identity controls

Identity & Access Engineer, III

General Counsel

• Provide direct legal support on a full range of North American employment law issues
• Advise on labor and employment law compliance
• Oversee and direct internal investigations

Assistant General Counsel

Financial Planning and Analysis

• Manage the full life-cycle recruitment process at multiple sites including sourcing prospective candidates, screening and interviewing candidates, creating and extending competitive offers and ensuring successful new hire starts.
• Collaborate with the broader TA team and hiring managers to develop a compelling recruitment & sourcing strategy to hire according to projected staffing plans and increase efficiency of Talent Acquisition.
• Work directly with hiring managers on sourcing and recruitment strategies, candidate management, interview and selection approach.
• Liaise between internal and external candidates and hiring managers.
• Engage with a diverse range of hiring managers to teach effective interviewing and assessment skills.
• Develop strong hiring manager partnerships and collaborate to make informed hiring decisions.
• Ensure the best candidate experience throughout the complete interview processes
• Lead interview debriefs and gather standardized interview feedback
• Effectively work within internal Applicant Tracking System (Workday), including requisition initiation and management, candidate communications, candidate dispositioning, and candidate workflow management

Talent Acquisition Specialist, Finance and Tech

Vice President

• Has overall responsibility for the PCI Pharma Services Quality Assurance and Regulatory Affairs programme in relation to D&M
• Devise and drive general quality strategic goals, objectives, and business priorities
• Maintain knowledge of regulatory requirements, ensuring all sites are appraised on requirements
• Proactively drive Quality initiatives and deliverables at the global strategic level to ensure business growth and excellence are maintained
• Maintain continuous improvement mindset
• Provide oversight of Quality revenue and profitability to ensure budgets are in accordance with agreed corporate targets
• Ensure the provision and delivery of training excellence to subordinates and co-workers with respect to current Good Manufacturing Practices
• Ensure the D&M sites are performing satisfactorily and maintaining desired quality metrics and KPIs via the company Quality Management Review system in relation to quality data
• Work closely with Business Development to ensure revenue earning opportunities within Quality and Regulatory are maximised, supporting the teams where required during client visits or conferences
• Works with subject matter experts (SMEs) internally and externally as required for strategic or quality initiatives
• Assists in technical feasibility assessments as a basis to provide quotations for present, potential and future work
• Liaises with customers on global technical matters e.g. specifications, supply chain assessments and establishment of technical agreements and other legislative requirements
• Works closely with the site leaders and site leadership teams to uphold a strong quality culture aimed at maintaining the highest standards of compliance and lowest risks to patients and customers
• Be proactive with quality initiatives across sites, drive continuous improvement while understanding risks
• Identify compliance risks across the PCI D&M sites and identify methods of remediation where appropriate working with local site leads
• Maintain permanent inspection readiness across the D&M segment
• Support regulatory inspections and response development and writing