Senior Director, Quality Control

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.Summary of Objective:

This position provides senior leadership and strategic direction for Quality Control (QC) operations across the NH Development and Manufacturing campus. The Senior Director, QC is accountable for the overall performance, compliance, and scalability of QC laboratory functions, including financial stewardship, operational excellence, and technical capability development. This role ensures the delivery of high-quality testing services in support of GMP manufacturing and client programs.

The Senior Director will lead and evolve QC capabilities to support business growth, regulatory expectations, and client needs, while serving as a key member of the Quality leadership team. This includes oversight of method lifecycle management (development, transfer, validation), raw material through stability testing, and QC support for formulation and process development. The role also has responsibility for laboratory expansion initiatives, including capital planning, capacity modeling, and implementation of new technologies and services.

This position serves as a primary client-facing leader for QC, engaging at a strategic level to support business development, program execution, and regulatory interactions.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Provide strategic and operational leadership for all Quality Control functions, ensuring compliant execution of cGMP testing including raw materials, in-process, release, stability, environmental monitoring, and clean utilities

Establish and drive QC vision, strategy, and long-term roadmap, aligned with organizational growth, regulatory expectations, and client needs

Oversee complex and critical investigations (deviations, OOS/OOT, EM excursions), ensuring robust root cause analysis and effective CAPA implementation across internal and external laboratories

Serve as client interface for QC, supporting business development, contract negotiations, and ongoing program governance

Build and maintain strong client relationships, proactively identifying opportunities to expand services and improve quality and delivery

Partner cross-functionally with Manufacturing, MSAT, Validation, and Quality Assurance to drive end-to-end product quality and process performance

Provide strategic oversight of method lifecycle management, including development, transfer, validation, and continuous improvement

Ensure timely and effective analytical support for formulation and process development programs

Lead and execute laboratory expansion and modernization initiatives, including facility design, technology implementation, capacity planning, and resource strategy

Develop and manage departmental budgets, capital investments, and resource planning to support operational and strategic objectives

Build, develop, and retain high-performing leadership and technical teams, fostering a culture of accountability, innovation, and continuous improvement

Ensure QC operations remain inspection-ready at all times, with full compliance to FDA, EMA, ICH, and global regulatory requirements

Support and lead regulatory inspections and client audits, serving as a key subject matter expert and spokesperson for QCDrive operational excellence initiatives, including digitalization,…