Senior Director, Quality Control

PCI Pharma Services; Bedford (NH); Vor Ort; USD 190.000 - 270.000; Vollzeit

Zusammenfassung

PCI Pharma Services in New Hampshire seeks a Senior Director, Quality Control to lead and shape QC operations across the development and manufacturing campus, driving cGMP testing, regulatory readiness, and scalable laboratory capabilities to support client programs.

The role partners with Manufacturing, MSAT, Validation, and QA to deliver high-quality testing, oversee method lifecycle management, budget planning, and expansion initiatives, while building a high-performing, compliant team.

Qualifikationen

• BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field; advanced degree preferred.
• 15+ years Pharmaceutical or Biotechnology industry experience.
• Experience leading a commercial, aseptic drug product quality control team.
• 7+ years QC management experience.
• Strong leadership to harmonize operations and compliance across functions.
• CMO experience preferred.
• Excellent verbal and written communication in a fast-paced environment.
• Mentor and lead 5+ direct reports across multiple sites.

Aufgaben

• Provide strategic and operational leadership for all Quality Control functions, ensuring compliant execution of cGMP testing.
• Establish and drive QC vision, strategy, and long-term roadmap aligned with growth and regulatory expectations.
• Oversee investigations (deviations, OOS/OOT, EM excursions) with robust root cause analysis and CAPA.
• Serve as client interface for QC, supporting business development and program governance.
• Lead laboratory expansion, capital planning, capacity modeling, and technology implementation.
• Ensure QC operations remain inspection-ready with FDA/EMA/ICH compliance.
• Support regulatory inspections and client audits; act as subject matter expert for QC.
• Drive digitalization, automation, and continuous improvement to enhance efficiency and data integrity.

Kenntnisse

Quality Leadership

Cross-functional Leadership

Client interface

Regulatory compliance

People management

Ausbildung

BS in Chemistry/Biochemistry/Microbiology/Biology

Jobbeschreibung

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

• 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

Special Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Qualifications

• 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

#LI-AL1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.

We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies.

We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.

We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.