Director, Quality Operations, Facilities & Validation - Hybrid

Role Summary

Director, Quality Operations, Facilities & Validation – Hybrid, based at the Rahway, New Jersey site. Leads Quality Operations, Facilities and Validation functions to support expansion of clinical development activities and ensures GMP-compliant quality systems for facilities, equipment, and automation used in clinical trial material supply. Builds and leads a growing team and partners with key groups to deliver expanding site capabilities.

Responsibilities

• Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities.
• Support the design phases and operational readiness of multiple significant cross-modality capital projects aligned with the expanding site mission.
• Drive quality from design through qualification, startup, and operations of new facilities, and maintain and sustain existing operations and facilities.
• Develop relationships with and provide Quality oversight of key partner groups that are expanding in size and scope of work.
• Lead and develop a growing team of professionals enabling an expanding site asset base.
• The successful candidate will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all relevant quality requirements and regulatory standards.
• Manage people and projects affiliated with Quality oversight of GMP facilities.
• Lead and perform quality assurance activities related to qualification and validation of facility, equipment, and automation assets in a complex and rapidly changing clinical development environment. Assure compliance with cGMP, regulatory expectations, and clinical filings.
• Provide Quality oversight of GMP processes, including calibration, qualification, validation, change management, quality risk management, and quality investigations.
• Lead and enable the capital asset lifecycle through phases from design through start-up to deliver and sustain compliant manufacture and testing of clinical trial material.
• Build effective, collaborative working relationships and create effective communications within and across organizations.
• Identify efficiency opportunities; propose and implement value added solutions.
• Demonstrate a Quality mindset while balancing operational needs to develop pragmatic solutions to complex, technical and compliance challenges.
• Ensure current industry best practices and benchmarks are applied to design and implementation of new GMP facilities and equipment.
• Lead people and actively foster employee development. Develop talent to evolve the workforce, to deliver and maintain an expanding GMP asset base at the Rahway site.
• The successful candidate will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all relevant quality requirements and regulatory standards.

Education

• Minimum education: Bachelor Degree in Scientific, Engineering, or related discipline.
• Preferred education: Advanced Degree

Qualifications

• Required: Minimum of 12 years of experience in Pharmaceutical / Biotechnology industry roles.
• Required: Experience in Quality and Operations, at pilot and/or commercial scale.
• Required: Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
• Required: Working knowledge of capital projects and facility operations.
• Required: Leadership of people, cross-functional teams, problem-solving situations.
• Required: Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.
• Preferred: Advanced to Expert level leadership and people management skillsets; with experience in leading, growing, and developing people and teams.
• Preferred: Advanced to Expert level technical knowledge in one or more elements of validation, facilities, equipment, utilities, automation, systems, unit operations in various product modalities, or associated technologies.
• Preferred: A combination of experiences foundational to knowledge of validation - in product or process development, engineering, scale-up, manufacturing, technical operations, technology transfer, facilities, equipment, automation, quality systems, and/or quality operations.
• Preferred: Advanced ability to identify and solve complex problems in a timely and efficient manner.
• Preferred: Knowledge and/or experience with capital project lifecycle.
• Preferred: Experience in R&D or clinical supply areas and processes.

Skills

• Auditing
• Capital Assets
• Capital Projects
• Change Management
• Client Relationship Building
• Clinical Development
• Clinical Supplies Management
• Clinical Trials
• Creativity
• Cross-Cultural Awareness
• Diversity Programs
• Facility Management
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Leadership
• Management Process
• Mentoring Staff
• People Leadership
• Pharmacovigilance
• Policy Implementation
• Process Improvements
• Quality Assurance Processes
• Quality Assurance Review
• Quality Assurance Systems

Additional Requirements

• Travel Requirements: 10%
• Flexible Work Arrangements: Hybrid
• Shift: 1st - Day
• Valid Driving License: Yes