Sr. Director, Quality Control and Microbiology | Job ID: 2801

Position Summary:

The purpose of this position is to provide leadership and direction to both the Quality Control and Microbiology laboratories in the Rockland County manufacturing site, ensuring high quality services to all customers and overall cGMP compliance with applicable regulations and policies, as well as the manufacture and distribution of products within standards as well as State and Federal Regulations. This position requires technical, strategic, and tactical skills to manage the activities and performance of the Quality Control and Microbiology departments.  

The Sr. Director provides strategic oversight to identify and implement key elements of business processes to support the Quality function. These include but are not limited to the identification and implementation management of key systems required for the continued delivery of goods and services in the areas of responsibility. Providing scientific, technical, and operational leadership in the areas of cGMP-compliant testing services that include characterizations, raw material, intermediate, and finished product testing, release, and stability testing, facility/utility monitoring and testing, method validation, assay transfer, stability/standards/controls, and microbiology.

Responsibilities:

• Supports overall management of assigned areas, including operations, budget, and personnel. Routinely interacts with leadership and team members professionally and cooperatively to accomplish goals. Gain the support of senior management with strong leadership and interpersonal skills, to achieve functional/site/company objectives.
• Interface with regulators, and inspectors and interpret cGMP requirements to solve technical issues using scientifically compliant solutions. Proficient with Quality Systems (OOS, CAPA, Deviations, etc.) and Data Integrity requirements. Direct experience supporting cGMP product manufacturing, testing, disposition, and distribution. 
• Establish, monitor, and improve critical KPIs (Quality Index) in the Microbiology and QC labs related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing. Act as a strong coach and mentor focusing on team development, training, and improved lab metrics.
• Strong leadership skills focusing on technical issue resolution/ investigations, improved lab performance, effective collaboration, flexibility, and multitasking of projects and priorities. 
• Ensure test methods and systems selected to have the capability of providing quality results while verification procedures used are adequate to determine the accuracy, precision, and other pertinent characteristics of the method. Ensure verification procedures are adequate to determine the method's accuracy, precision, and other pertinent performance characteristics. 
• Participate, conduct, and/or write OOS and Nonconformance/CAPA investigations and conduct audits of analytical testing documentation.
• Partner with R&D for developing method transfer protocols on instrumentation as required.
• Design and execute lab experiments with microbiologists, analysts, and/or QA Management input. 
• Direct the site laboratory activities required to maintain the PDI Quality System, ISO requirements, and Federal Regulations.
• Oversee and ensure technical training efforts are provided regarding the education of lab associates regarding cGMP compliance and requirements, as well as other regulatory and sanitation requirements, to optimize the function’s responsibilities.
• Direct all CAPA preparation and investigation activities, deviation compliance, and customer complaint documentation.
• Prepare and manage the QC/Micro departmental budget.
• Act as the primary liaison with Regulatory Affairs and Corporate Quality Systems regarding policies, guidelines, and compliance issues.
• Raise compliance issues to management's attention and work with them to address them promptly. Actively participates in internal and external Management and Quality meetings, including inspections and audits.
• Ensure the laboratories are functioning in a high state of readiness and compliance, and meet all established criteria for testing and product release schedules.
• Directs all activities associated with product or facility non-compliance conditions. Acts as the senior site Quality resource regarding decisions associated with holding or releasing non-compliant products.
• Ensures that all documentation regarding PDI’s Quality System Requirements is effectively maintained.
• Effectively manages the QRC and CAPA compliance meetings.

Qualifications:

Education

• Minimum bachelor’s degree in biology or chemistry. An advanced degree in life sciences is desirable. ASQ or CQA Certification a plus

Required Knowledge:

• Experienced leader in Microbiology and Quality Control Processes. 

• Excellent interpersonal and people leadership skills are a must.

• Knowledge of Quality Systems design, implementation, and maintenance.

• Keen understanding of cGMPs pertaining to manufacturing and laboratory environments. Proficiency in Windows operating system and Quality System applications and technologies.

• General knowledge of validation requirements, manufacturing processes, auditing, etc.

• In addition to normal academic educational requirements, chemistry education is required. Knowledge of GLPs as it applies to laboratory techniques and systems processes, auditing, etc

Experience:

• Must have a Minimum of 15-20 years in regulated pharmaceutical laboratory experience in microbiology, quality control, and/or analytical departments, including prior supervisory experience.

• Excellence in supporting FDA audits with items related to QC/Micro labs.

• Experience in developing and executing validations for products, processes, and equipment.

• ISO certification experience is beneficial but not necessary.

• Minimum of 10+ years of experience working in an FDA drug (preferably OTC) regulated manufacturing environment. Strong background in compliance requirements.

• Experience with successful FDA remediation

• Knowledge of the operation and procedures required by the analytical chemistry and microbiology laboratories.

• Experienced in conducting facility and systems audits and leading corrective action teams.

• 10+ years managing large teams and coaching and developing talent.

• Extensive experience managing CAPA system execution.

• Experienced in preparing SOPs, WIs, deviations, investigations, CAPA, etc.

• Capable of leading customer/regulatory audits and effectively responding to issues and recommendations.

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