Sr. Manager, Quality Systems and Compliance Technology

Position Summary:

We are seeking a highly motivated and detail-oriented Senior Manager, Quality Systems & Compliance Technology, to lead and manage our electronic Quality Management System (eQMS). This role is critical to ensuring compliance with internal procedures and global regulatory requirements. This role will be responsible for building, maintaining, and continuously improving scalable, inspection-ready Quality Systems that support clinical development, CMC, regulatory, and external partner oversight in a fast-paced biotech environment.

This position will serve as a cross-functional Quality Systems leader with responsibility for QMS governance, workflows, computer system validation, and vendor/system qualification. The role is intended for a candidate with demonstrated experience leading enterprise QMS platforms, validating regulated SaaS systems, supporting GxP compliance across GMP/GCP/GDP environments, and preparing organizations for regulatory inspections.

Essential Duties and Responsibilities:

Quality Systems Governance

• Provide strategic ownership and operational oversight of enterprise Quality Systems, including document control, training, quality events, CAPA, change control, deviations, complaints, audits, and related workflows.
• Establish and maintain Quality Systems governance frameworks, policies, SOPs, role structures, workflows, and process controls to ensure compliance with internal procedures and applicable regulatory expectations.

• Partner with QA, Clinical Operations, CMC, Regulatory Affairs, IT, and external partners to ensure Quality Systems are scalable, effective, inspection-ready, and aligned with business needs.
• Monitor Quality System performance, identify trends, and drive continuous improvement across quality processes and electronic workflows.
• Support management review through quality metrics, process health indicators, training compliance data, periodic review status, audit outcomes, and quality event trends.

Veeva QMS Administration and Compliance Technology

• Lead administration, configuration, enhancement, and lifecycle management of eQMS platforms, including modules for documents, training, quality events, CAPA, change control, audits, and controlled copies.
• Lead or support migration and implementation activities for regulated systems, including QMS, eTMF, regulatory systems, EDC, SSO, and related GxP platforms.
• Develop and execute digital transformation strategies to improve system usability, compliance, metadata governance, role-based access, workflow efficiency, and inspection readiness.
• Collaborate with business process owners and IT to define requirements, assess system changes, manage user acceptance testing, and ensure controlled implementation.
• Provide hands-on support to users and stakeholders regarding system functionality, workflows, documentation, training, and compliance expectations.

Computer System Validation and Data Integrity

• Lead or support full lifecycle CSV activities for regulated SaaS and GxP systems, including validation planning, user requirements, risk assessments, configuration specifications, IQ/OQ/PQ, traceability matrices, testing, deviations, validation reports, and release documentation.
• Apply risk-based validation principles consistent with GAMP 5, data integrity expectations, and applicable GxP requirements.
• Ensure validation documentation is complete, accurate, current, and audit-ready.
• Support periodic reviews, system change controls, access reviews, vendor assessments, and lifecycle maintenance for validated systems.
• Partner with IT, system owners, vendors, and business stakeholders to ensure regulated systems remain compliant and fit for intended use.

Audit, Inspection Readiness, and Vendor/System oversight

• Lead or support internal audits, external vendor audits, system qualification activities, and inspection readiness initiatives.
• Prepare documentation, metrics, system access, audit trails, validation evidence, and process narratives to support regulatory inspections and partner audits.
• Support inspection response activities, including documentation retrieval, back-room support, observation assessment, CAPA planning, and remediation tracking.
• Oversee vendor and system qualification activities for technology partners, regulated service providers, CROs, CMOs/CDMOs, clinical sites, distribution partners, and other GxP suppliers as applicable.
• Maintain inspection readiness across Quality Systems, regulated electronic systems, document control, training, and quality event processes.

Education & Experience:

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Minimum 7 years of experience in QA within the biotech or pharmaceutical industry.
• Proven experience managing electronic QMS platforms, preferably Veeva.
• Experience leading or supporting CSV activities for regulated GxP systems.
• Strong working knowledge of FDA, EMA, ICH, GxP, GDP, and data integrity expectations.
• Excellent organizational, communication, and interpersonal skills.
• Ability to work independently in a hybrid team environment.

Additional Skills, Knowledge, and/or Attributes:

• Experience in a small or startup biotech environment.
• Familiarity with remote collaboration tools and virtual team dynamics.
• Ability to balance strategic Quality Systems leadership with hands-on execution.
• Strong understanding of how electronic systems, SOPs, training, workflows interact within an effective QMS.
• Strong documentation, technical writing, and process-mapping skills.
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Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office.