Associate Director, Quality Assurance- Validation- Hybrid

Job Description

The Associate Director Quality Assurance, Facilities, Validation & Automation will provide Quality Assurance oversight and support to Good Manufacturing Practice (GMP) facilities, equipment, and laboratories within the Research and Development Division development space. 

This includes both existing facilities, equipment, and laboratories as well as those associated with new capital investments projects.  The role will also work to ensure new facility design, changes, and improvements adhere to international Good Manufacturing Practice (GMP) requirements and applicable guidance for the production of clinical Good Manufacturing Practice (GMP) drug substance, drug product and packaged goods across all modalities to ensure worldwide clinical supplies are supported and suitable for use.

The primary responsibility will be at the Rahway, NJ site though the expectation is that support is provided as necessary to other sites within the clinical network (e.g., West Point, PA site).  The role is reports to the Director of Facilities and Validation.

Primary Responsibilities

• Responsible for providing quality assurance support and oversight for commissioning/qualification of the facilities, equipment and instruments in the manufacturing facility and the associated laboratories.
• Responsible for providing quality oversight for automation systems for new facilities and upgrades to the existing facilities.  Automation systems include systems such as Delta V, BAS, BMS & SCADA.
• Responsible for quality oversight cleaning and thermal validation.
• Responsible for the review and approval of Standard Operating Procedures (SOPs).
• Provide Quality support for Environmental Area and Utility Performance Qualification Plans, Protocols and Reports.
• Quality ownership for new capital projects which can include new facility associated utilities and equipment.
• Leading routine process support and improvement activities.
• Providing Quality guidance for daily production support, projects, deviations, and changes.
• Provide Quality support in maintaining facilities and equipment systems in a state of permanent inspection readiness.
• Serving as Quality Subject Matter Expert during regulatory inspections and audits.

Education Minimum Requirements

• Bachelor Degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or a related field with ten (10) years of relevant experience. Masters Degree preferred.

Experience and Skills

Critical Skills

• Experience in regulated or Good Manufacturing Practice (GMP) manufacturing and/or Quality support of manufacturing operations
• Strong and demonstrated experience in Facility, Equipment, Instrument, and computer system validation.
• Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and supporting clean utilities.
• Familiarity with change control systems and Quality assessment of change in a current Good Manufacturing Practice (cGMP) production environment
• Experience with deviation management and associated systems
• Experience with sterile processing and sterility assurance practices and guidelines
• Strong experience with QRM (Quality Risk Management)
• Strong working knowledge of SDLC, GAMP and automation systems
• Demonstrated project management skills.

Critical Behavioral and Leadership Competencies

• Cross-functional collaboration
• Focus on delivering customer value.
• Personal Attributes and Characteristics
• Demonstrated interest working in a diverse and constantly changing environment.
• Detail oriented and organized.

#EBRG

#VETJOBS

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive co