Position Overview:

We are seeking a Director / Senior Director, Quality Control Automation and Digitalization to lead the strategic transformation of Quality Control operations through advanced automation and digital platforms. This role blends strategic leadership with deep hands-on technical expertise in laboratory automation, digital solutions, and GMP operations. The position will serve as the QC Automation Lead, responsible for overseeing and coordinating end‑to‑end automated analytical workflows across multiple functions, including Analytical Development, Automation, Computational Biology, Quality Control, Quality Assurance, Information Technology, and Validation. This leader will drive cross‑functional alignment to ensure streamlined processes and timely delivery of robust, compliant analytical methods and procedures in support of GMP testing. In addition, this role is accountable for implementing comprehensive training programs to strengthen QC capabilities in automated and digital platforms, ensuring scientific rigor, data integrity, and operational excellence. The Senior Director/Director will foster a culture of innovation and continuous improvement, positioning QC to support current and future portfolio and regulatory needs.

Primary Responsibilities:

• Serve as the QC Automation Lead, providing deep technical expertise and strong compliance acumen to design, deploy, and sustain automation and digital solutions supporting GMP analytical methods and procedures.
• Partner strategically with cross‑functional stakeholders—including Analytical Development, Automation, Computational Biology, Quality Control, Quality Assurance, Information Technology, and Validation—to define and implement integrated, end‑to‑end automation workflows.
• Oversee the full lifecycle of automated solutions, including instrumentation and software onboarding, qualification, and validation; robust script development and testing; and technical transfer, qualification, and validation of automated analytical methods. This includes complex modalities such as cell‑based functional assays, flow cytometry, ddPCR, ELISA, and NGS.
• Drive alignment on deliverables and exit criteria across Research, Development, and Commercial phases, including pre-qualification package signoffs, SME training completion, and qualification package approvals.
• Direct and facilitate investigation and resolution of complex technical challenges related to automated systems, ensuring scientific rigor, data integrity, and compliance with GMP expectations.
• Design and implement comprehensive training programs to build QC capability and confidence in automated and digital platforms, ensuring strong scientific and technical understanding across the organization.
• Mentor and develop team members in the design, authoring, execution, and lifecycle management of automated analytical protocols within GMP environments.
• Establish and maintain technical standards, best practices, and governance for automation scripting, validation documentation, system lifecycle management, and troubleshooting methodologies.
• Recruit, develop, and retain top talent with expertise in laboratory automation, liquid handling platforms, relevant programming languages, and cell and gene therapy analytical techniques.
• Foster a highly collaborative environment that effectively bridges scientific expertise, automation engineering, and regulatory compliance, enabling innovation while maintaining inspection readiness.

Qualifications:

• Advanced degree (PhD preferred) with 15+ years of relevant experience in Quality Control, laboratory automation, and pharmaceutical or biotechnology operations, including 8+ years in progressively responsible leadership roles with demonstrated advancement to Director‑level scope.
• Extensive hands‑on automation experience, including 8+ years working with liquid handling platforms (e.g., Hamilton, Tecan), with demonstrated expertise in script development, validation, troubleshooting, and lifecycle management within GMP environments.
• Proven expertise integrating automated workflows with LIMS and other enterprise digital systems to support compliant data management and end‑to‑end process automation.
• Deep technical understanding of molecular biology, cellular, and immunoassay techniques, including transfection/transduction workflows, ddPCR/qPCR, flow cytometry, ELISA, and next‑generation sequencing (NGS).
• Strong track record leading cross‑functional automation initiatives in regulated biopharmaceutical settings, including oversight of instrument and software IQ/OQ/PQ, analytical method qualification and validation, and method lifecycle management.
• Demonstrated success in building, leading, and developing high‑performing technical teams, with a proven ability to mentor, coach, and retain top talent.
• Exceptional communication and influence skills, with the ability to engage senior leadership and align diverse stakeholder groups around complex technical and operational initiatives.
• Strategic mindset with the ability to translate business and portfolio needs into scalable automation strategies, roadmaps, and executable plans.