We are seeking a Manager, Quality Assurance Client Engagement to lead software quality and validation initiatives across regulated systems while ensuring compliance with industry standards and supporting continuous process improvement. This role offers the opportunity to collaborate with cross-functional teams, influence quality strategy, and develop high-performing professionals in a dynamic and growing environment.
What We Offer- Competitive compensation
- Medical, dental, and vision coverage
- Paid time off
- Employee assistance and wellness programs
- Life and disability insurance
What You'll Be Doing- Partner with eClinical development teams to ensure the accuracy, quality, and consistency of software development deliverables.
- Author, review, maintain, execute, and approve software validation documentation, including risk assessments, validation plans, test plans, test reports, requirements specifications, release memos, and validation summary reports.
- Promote software quality and validation best practices across development teams and the broader organization.
- Report quality findings, validation results, and significant issues to leadership while supporting the resolution of anomalies and compliance concerns.
- Support and enhance document management, validation, and change control processes for regulated systems.
- Assist in the development, review, revision, and implementation of Standard Operating Procedures (SOPs).
- Provide training, guidance, and compliance support to employees regarding SOP interpretation and adherence.
- Lead, mentor, coach, and develop team members while fostering a culture of accountability and continuous improvement.
- Manage employee performance, staffing activities, workforce planning, and professional development initiatives.
- Support hiring activities, including candidate interviews, hiring recommendations, onboarding, and training of new team members.
- Drive quality process improvements and contribute to initiatives that enhance regulatory compliance and operational effectiveness.
- Lead investigations into quality issues, identify root causes, implement corrective actions, and recommend preventive measures.
- Contribute to organizational success by supporting cross-functional projects and other quality-related activities as assigned.
- Maintain awareness of evolving regulatory requirements, industry trends, and quality assurance best practices through professional development and continuous learning.
What We Look For- Bachelor's degree in Life Sciences, Regulatory Affairs, Quality, or a related field required.
- Advanced degree preferred.
- Minimum 5 years of experience in software validation, quality assurance, or a related quality function within the pharmaceutical, biotechnology, CRO, or regulated healthcare industry.
- Previous leadership or people management experience preferred.
- Experience developing, reviewing, and maintaining Standard Operating Procedures (SOPs).
- Strong knowledge of computerized systems validation (CSV), quality management systems, and software development lifecycle processes.
- Familiarity with applicable U.S. and European regulations, guidance documents, and regulatory expectations.
- Demonstrated ability to lead cross-functional teams and influence stakeholders at various organizational levels.
- Excellent written and verbal communication skills with the ability to communicate complex quality concepts clearly and effectively.
- Strong organizational, analytical, problem-solving, and decision-making skills.
- Proven ability to manage multiple priorities and deliver results in a fast-paced environment.
- Highly motivated self-starter with strong leadership, collaboration, and relationship-building capabilities.
- High degree of integrity, professionalism, and commitment to quality and compliance.
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