Director, Quality Operations, Facilities & Validation - Hybrid

About the position The Director, Quality Assurance will be responsible for team leadership and subject matter expertise in Quality Operations, Facilities and Validation at the our Company's Rahway, New Jersey site. This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including, but not limited to the following: 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 that are aligned with the expanding site mission. Drive quality from design through qualification, start-up, and operations of new facilities as well as maintain and sustain existing operations and facilities. Develop relationships with and provide Quality oversight of key partner groups that are commensurately 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.

Responsibilities

• 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 & 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.

Requirements

• Minimum of 12 years of experience in Pharmaceutical / Biotechnology industry role(s).
• Experience in Quality and Operations, at pilot and/or commercial scale.
• Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
• Working knowledge of capital projects and facility operations.
• Leadership of people, cross-functional teams, problem-solving situations.
• Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

Nice-to-haves

• Advanced to Expert level leadership and people management skillsets; with experience in leading, growing, and developing people and teams.
• 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.
• 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.
• Advanced ability to identify and solve complex problems in a timely and efficient manner.
• Knowledge and/or experience with capital project lifecycle
• Experience in R&D or clinical supply areas and processes.

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

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