Director, QC

Quality Control Department Leader

PCI Pharma Services is looking for a strategic and operational leader for the Quality Control Department within a fast-paced, multi-client CDMO environment. The role oversees QC Chemistry, Method Transfers, Stability, Raw Materials, and Logistics operations supporting GMP manufacturing, release testing, investigations, and regulatory compliance.

This people leader is responsible for driving laboratory excellence through robust quality systems, laboratory infrastructure, and electronic platforms (LIMS/CDS/SDMS), while delivering practical, data-driven solutions that strengthen compliance, efficiency, and business performance. Success in this role requires a highly collaborative and influential leader who can build high-performing teams, develop future leaders, and foster a culture of accountability, innovation, and continuous improvement while ensuring the highest standards of product quality and operational execution.

Core Responsibilities:

• Lead and provide strategic direction for Quality Control Department supporting GMP manufacturing activities, including method transfer, in-process testing, method verification, release testing, stability programs, and reference standard qualification.
• Drive innovation and continuous improvement at the strategic site level while ensuring disciplined tactical execution across laboratory operations.
• Oversee all laboratory infrastructure and support systems required for GMP testing and release activities, including sample management, statistical support, and electronic laboratory systems.
• Provide leadership for laboratory electronic systems management and associated scientific software used to generate and maintain electronic records and batch release data.
• Provide scientific leadership and technical problem-solving support for complex laboratory and manufacturing challenges.
• Lead generation and review of batch release data, certificate of analysis issuance, final product disposition, and stability trending/shelf-life analysis.
• Analyze operational and quality data to identify trends, deliver actionable insights, and implement practical solutions that improve compliance, efficiency, and performance.
• Partner cross-functionally to develop sustainable quality systems, strengthen operational controls, and ensure the highest level of product quality and compliance.
• Establish and implement robust systems for tracking, escalating, and driving closure of quality records and laboratory events, including Deviations, CAPAs, OOS investigations, and audit observations.
• Support development of meaningful KPIs and metrics that provide visibility to laboratory performance, quality trends, and continuous improvement opportunities.
• Manage departmental budget, headcount planning, capital projects, and resource allocation to support current and future business needs.
• Serve as a client-facing SME for Analytical Technologies and QC matters, supporting client interactions, process transfers, investigations, testing strategies, and regulatory discussions.
• Maintain consistent on-site leadership presence and engagement to support operations, teams, and business priorities.

Leadership Responsibilities:

• Lead with impact, influence, and accountability while fostering a culture of collaboration, engagement, and continuous improvement.
• Build and develop a high-performing laboratory organization by coaching leaders, mentoring team members, and strengthening organizational capability and succession planning.
• Build strong cross-functional partnerships to align quality and laboratory operations with broader site and company objectives.
• Establish high-performance expectations, clear accountability, and a results-driven environment focused on operational excellence and compliance.
• Drive employee engagement and development through coaching, delegation, goal setting, performance management, and continuous feedback.
• Maintain transparent and effective communication across teams and organizational levels.
• Champion practical, data-driven decision-making and continuous improvement initiatives that reduce variability, increase efficiency, and strengthen compliance.
• Provide leadership to ensure adherence to EHS policies, GMP requirements, and PCI Pharma Services quality standards.
• Embody PCI Pharma Services' cultural values through daily leadership behaviors, professionalism, collaboration, and commitment to excellence.
• Develop and execute short- and long-term organizational strategies that strengthen technical capability, operational readiness, and business growth.
• Represent the organization with professionalism and credibility during client interactions, audits, inspections, and internal leadership engagements.

Qualifications:

• Bachelor's degree in Life Sciences or related discipline required; advanced degree (MS or PhD) in Life Sciences, Engineering, or related field preferred.
• Minimum of 12 years of progressive Quality Control experience within GMP-regulated pharmaceutical, biotech, or CDMO environments; multi-client, multi-product CDMO experience strongly preferred.
• Minimum of 6 years of proven leadership experience managing technical and operational teams within a GMP environment.
• Strong working knowledge of cGMP regulations and quality systems, including expertise in laboratory electronic systems lifecycle management and data integrity requirements.
• Demonstrated experience with laboratory systems such as LIMS, CDS, SDMS, ELN, and other enterprise-level electronic data management platforms.
• Proven ability to lead complex QC operations, drive strategic initiatives, and deliver results within fast-paced and highly regulated manufacturing environments.
• Strong leadership presence with demonstrated success building, mentoring, and developing high-performing teams and future leaders.
• Demonstrated ability to influence cross-functional stakeholders, drive alignment, and lead effectively within a matrixed organization.
• Strong analytical, problem-solving, and decision-making skills with the ability to translate data into practical, risk-based solutions.
• Excellent verbal, written, and interpersonal communication skills with the ability to engage effectively at all organizational levels and with external clients.
• Advanced proficiency in Microsoft Office applications; experience with JMP or other statistical analysis software preferred.
• Experience participating in or leading the development of corporate methods, operational strategies, technical standards, and performance frameworks.Demonstrated commitment to operational excellence, continuous improvement, compliance, and fostering a strong quality culture.

Benefits:

• The base salary hiring range for this position is $151,360 - $170,280 plus eligibility for an annual performance bonus
• Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise
• PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k)