Senior Director, Quality Control

PCI Pharma Services•Bedford, NH

11d

About The Position

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.

Requirements

BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field. Advanced level degree preferred
15+ years Pharmaceutical or Biotechnology industry experience
Prior experience in leading a commercial, aseptic drug product quality control team
7+ years previous QC management experience
Quality leadership experience working on cross-functional teams to harmonize operational, testing and compliance processes
Prior experience in a CMO or dealing with CMOs preferred
Demonstrates excellent verbal, written, and interpersonal communication skills
Demonstrated ability to perform in a fast paced environment
Highly developed leadership capabilities to motivate and inspire teams
Independently motivated, detail oriented and good problem solving ability.
Demonstrates a strong customer service orientation with effective follow through
Driven to excellence while encouraging others to engage in process improvement and innovation
A leader who inspires and motivates, through excellent listening skills and a willingness to mentor team members
Management of 5+ direct reports across multiple sites with overall group greater than 50 people

Responsibilities

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 QC
Drive operational excellence initiatives, including digitalization, automation, and continuous improvement to enhance efficiency, robustness, and data integrity
Provide strategic oversight for supplier and contract laboratory quality, ensuring appropriate governance and performance management
Support regulatory submissions and client communications related to QC, including responses to health authority inquiries
Monitor industry trends and emerging technologies to advance QC capabilities and maintain competitive advantage
Perform other duties as assigned by executive leadership