Sr. Director, eCompliance – Global Quality Technical Operations

PCI Pharma Services; Only (TN); On-site; USD 100,000 - 130,000; Full time

Job summary

PCI Pharma Services is seeking an experienced IT Quality professional to lead compliance initiatives and manage validation frameworks. You will oversee the transition to CSA models and ensure cloud-based platforms comply with regulations.

The ideal candidate has at least 10 years in IT Quality within a GxP environment, with a focus on managing organizational change and system implementations. A bachelor's degree in a relevant field is required.

Qualifications

• Minimum of 10 years of progressive experience in IT Quality or eCompliance role.
• Proven experience managing large‑scale organizational change and implementations.
• Exceptional communication skills for interfacing with regulatory inspectors.

Responsibilities

• Define the Global Computerized System Validation Master Plan.
• Establish standardized Software Development Life Cycle requirements.
• Develop and implement protocols for system audit trails.

Skills

Leadership

Cross-functional influence

Technical compliance

GxP knowledge

Advanced computer skills

Problem-solving

Education

Bachelor’s degree in Information Technology

Tools

MasterControl QMS

LIMS

PLC/SCADA systems

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. Our investment is in people who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Essential Duties and Responsibilities

• Modernized Validation Framework: Define and maintain the Global Computerized System Validation (CSV) Master Plan, transitioning the organization toward Computer Software Assurance (CSA) models to prioritize critical‑thinking and risk‑based testing over rote documentation.
• Standardized SDLC: Establish standardized Software Development Life Cycle (SDLC) requirements for all GxP systems, overseeing the full lifecycle from User Requirement Specifications (URS) and Configuration Specifications to Performance Qualification (PQ) and formal decommissioning.
• Cloud & Infrastructure Oversight: Partner with Global IT to ensure that cloud‑based platforms (SaaS/PaaS) and underlying IT infrastructure are qualified and maintained in a validated state, including oversight of vendor audits and Service Level Agreements (SLAs).
• ALCOA+ Enforcement: Serve as the corporate custodian for Data Integrity, ensuring all digital records—from lab instruments to the Data Lakehouse—meet ALCOA+ principles.
• Audit Trail Review Programs: Develop and implement standardized protocols for the periodic review of system audit trails, ensuring site teams have the tools and training to identify and remediate data anomalies.
• Data Mapping & Risk Assessment: Lead comprehensive data mapping exercises across global sites to identify high‑risk data flows and implement technical controls (e.g., electronic signatures, restricted permissions) to mitigate risks.
• MasterControl Implementation: Provide technical compliance oversight for the enterprise‑wide rollout of MasterControl QMS and eBatch Record (eBR), ensuring that global templates and site‑specific configurations maintain a high level of regulatory rigor.
• AI & Advanced Analytics Governance: Establish the compliance framework for AI‑assisted batch release and predictive modeling pilots, ensuring that "black box" algorithms are governed by the human‑centric principles outlined in the EMA Reflection Paper on AI.
• Operational Technology (OT) Integration: Collaborate with MS&T and Engineering to validate the integration of shop‑floor systems (e.g., Ignition MES, LIMS, PLC/SCADA) with enterprise‑level data architectures.
• Change Management: Lead organizational change efforts to embed "Compliance by Design" into the company culture, ensuring that site‑level personnel understand their roles as data owners.
• Global IT Alignment: Act as the primary Quality liaison to Global IT for the deployment of new technologies, ensuring that cybersecurity protocols and disaster recovery plans (including paper‑based fallback procedures) meet GxP requirements.
• Site Team Support: Provide "boots‑on‑the‑ground" assistance to site leadership during complex system deployments, helping to navigate technical hurdles while maintaining compliance standards.
• Inspection Leadership: Serve as the lead Subject Matter Expert (SME) for eCompliance and Data Integrity during regulatory inspections (FDA, MHRA, EMA, etc.), confidently defending PCI’s digital validation and data governance strategies.
• Quality Metrics: Develop and monitor Key Performance Indicators (KPIs) related to system health, validation status, and data integrity compliance, using these metrics to drive proactive continuous improvement initiatives.
• External Benchmarking: Monitor the evolving international regulatory landscape (e.g., PIC/S, WHO, ISPE) to ensure PCI Pharma remains at the forefront of global eCompliance trends.
• This position may require extra hours and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by leadership.

Supervisory Responsibilities

• Supervises 1–10 employees.

Required Qualifications

• Education: Bachelor’s degree in Information Technology, Computer Science, Quality Assurance, or a related scientific/technical discipline.
• Experience: Minimum of 10 years of progressive experience in an IT Quality, eCompliance, or Computer Systems Validation role within a GxP environment.
  • Proven experience managing large‑scale organizational change and digital system implementations.
  • Deep technical expertise in GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and GDPR.
• Leadership: Exceptional ability to influence cross‑functional stakeholders and translate complex technical requirements into actionable compliance strategies. Strong communication skills are essential for interfacing with both technical teams and regulatory inspectors.
• Bachelor’s Degree in a related field and/or 10+ years related experience and/or training.
• College Level Mathematical Skills.
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Other Required Skills.

Preferred Qualifications

• Master’s Degree (M.A.) in related field and/or 5+ years related experience or training.
• Ability to work independently and/or as part of a team.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.