Our biotechnology client is seeking an Associate Director Quality Clinical Manufacturing who will report into the Senior Director of Quality and will be responsible for the oversight and management of Quality at the Clinical manufacturing site in Allendale, NJ. This position is responsible for managing the quality oversight to ensure the design, qualification, and daily operation are in compliance with FDA, EU and Japanese regulations. Core responsibilities include, but are not limited to, management of resources (human resources and financial resources), development of organization to support clinical manufacturing, and hosting client audits. Collaborates with other departments to support organizational and functional strategy. This is a key role for the site leadership of the clinical manufacturing facility. 

• Provide quality oversight to design, qualification, and operation of the facility.
• Design and prioritize quality organization to support clinical manufacturing to include but not limited to the oversight of
• Document management
• Investigations and change control
• Technical transfer approvals
• Qualifications/Validations – facility, equipment, and methods (approvals)
• Labeling
• Batch Record release
• QA shop floor
• Incoming release
• QA Client support
• Ensure state of inspection readiness
• Maintain site level quality governance documents such as the 4PC Quality Manual
• Oversee Management Review for 4PC
• Ensure production support and cGMP compliance.
• Manages quality resources (human resources and financial resources). Prepares and tracks budget and Capex activities, including staff overtime and contractor budgets, within their scope of accountability and responsibility.
• Provides strong leadership and quality guidance
• Conducts performance evaluations for personnel. Develop goals and manage individual development plan for employee.
• Manages the training programs for quality.
• Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment. 
• Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
• Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary.
• Maintains employee work schedules including assignments, job rotation, training, vacations, and paid time off, coverage for absenteeism, and overtime scheduling.
• Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM). 

REQUIREMENTS

• Bachelor of Science in biological sciences or other relevant field of study. Advanced degree preferred.

• 15+ years of relevant experience of which at least 5-10 years in a Management role overseeing QA/QC environment with applicable clinical or commercial experience. Experience with environmental monitoring and aseptic processing is preferred.
• Knowledge of FDA, Japan and EMEA regulations and a working knowledge of root cause analysis.
• Understanding of quality system applications, including the training, deviations, CAPA management, etc.
• Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
• Experience in organizing and leading teams.
• Experience participating in health authority inspections and/or client audits.
• Understand requirements pertaining to aseptic manufacture of cellular products.
• Strong understanding of Tech Transfer and Method Validation
• Ability to work effectively with clients in a contract manufacturing environment.
• Familiarity with the product development process for biological products is helpful.
• Ability to recruit, lead and develop a high-performance manufacturing organization.
• Strong written and oral communication skills
• Ability to think strategically and tactically (detail-oriented)
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Analytical and problem-solving skills
• Strong written and oral communication skills
• Meeting management/facilitation skills/teamwork
• Ability to multi-task team is essential
• Flexible and able to adapt to company growth and evolving responsibilities.
• Ability to effectively interface with peer group in the company and work collaboratively to achieve company goals.
• Collaborates with other team members and demonstrates outstanding interpersonal skills.
• Ability to work autonomously in an entrepreneurial, fast paced environment.
• Strong business acumen
• Ability to think strategically and tactically (detail-oriented)
• Flexible and able to adapt to company growth and evolving responsibilities
• Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.
• Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary.
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids. 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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