Vice President, Quality Assurance

Title: Vice President, Quality Assurance 
Location: Chicago Metro Area, IL 
Salary: Open/Commensurate with experience 

Job Summary
Our client develops advanced transfusion medicine, cell therapy, infusion, and clinical nutrition technologies that help to increase the impact of donors and collectors in blood and plasma centers, scale the discoveries of researchers in biotechnology labs, and expand patient treatment options and enhance drug administration safety in acute care facilities.

The Vice President (VP), Plant Quality Assurance is responsible for developing and executing global quality strategy at our clients Melrose Park site. This includes leadership and oversight of all quality assurance, quality systems, and compliance functions to ensure the facility operates in compliance with regulatory and corporate requirements and serves as Management Representative. The VP will provide strong leadership and excellent managerial skills in motivating, coaching, developing, and retaining a high-performance Quality organization, as well as establishing and maintaining a quality-oriented culture throughout the site.

Responsibilities

• Responsible for administration of Manufacturing Quality Assurance and Compliance to assure timely delivery of results to manage the company objectives and production as well as new product introduction on time. Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Participates in regulatory inspections of the facility. Assumes responsibility for major projects or contract manufacturing as assigned by the EVP, QM Generics, IV Fluids & Nutrition.
  
• Interacts regularly with Regulatory Affairs, Sales, Corporate Quality Assurance, and DDPM personnel. Routinely interacts with Regulatory Agencies including, but not limited to, FDA and DEA. The responsible party for dealing with third party manufacturing for quality issues in their assigned plant.
  
• Has Quality decision authority at the plant overall. Will have signing authority over QA decisions at D/MRB.
  
• Directly manages the Documentation Managers, Critical Systems, MQA, LQA Product Release and Compliance Managers at their assigned facility.
  
• Administers, reviews, and approves regional standard operating procedures, validation documentation, and manufacturing discrepancy reports. Provides cGMP guidance to all departments engaged in the production of pharmaceutical products.
  
• Assumes responsibilities for the daily functional activities and has authority to make decisions for the facility QA department in internal and external meetings. Assumes responsibilities for major projects, such as contract manufacturing, new products, or facility renovations, as
  
• assigned by the EVP, QM Generics, IV Fluids & Nutrition. Actively participates in and supports Continuous Improvement, and Product Transfer Teams.
  
• Manages the administration of the Quality system in the Quality Organization for the Melrose Park facility. Develops personnel, administers budget, plans for future resource needs with regard to personnel, equipment, and facility.
  
• Directs investigations of product complaints and completion of appropriate documentation for products manufactured in their assigned facility. Provides technical details as required in a manner consistent with the confidential and proprietary nature of the information. Interacts with both the Medical Affairs and Vigilance Departments as needed.
  
• Leads Regulatory/FDA inspections on behalf of their assigned facility by providing information or expediting/obtaining information required by the inspectors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
  
• Develops QA and Compliance personnel to better accomplish and perform their duties as professional quality managers, supervisors, and technicians.
  
• Ensure adequate training is provided and complete for the employees in their respective function.
  
• Ensure department personnel are aware of the Environmental and Energy Management System including Environmental and Energy Policy.
  
• Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management System

Requirements

• B.S. Science with a minimum of 10 years work related experience including a minimum of five years as manager or above. Advanced degree strongly preferred.
  
• Ability to provide clear communication of investigational circumstances to supervisors so that proper risk management decisions can be facilitated by senior management
  
• Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a product quality issue.
  
• Ability to operate effectively in an environment with high levels of ambiguity.
  
• Proven critical thinking aptitude in a demanding and fast paced environment.
  
• Possesses visionary leadership; ability to identify new trends in the quality and regulatory landscape
  
• Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization.
  
• Demonstrated experience of successfully leading a Quality leadership team, preferable in a matrix-style organization.
  
• Advanced training or experience in cGMPs and GLPs. Knowledge of global regulations including FDA, DEA and other Tier 1 regulatory agencies. Demonstrated success in executing multiple major quality initiatives (such as: implementation of IT systems, upgrading plant regulatory status, commissioning new plant operation, etc.).
  
• Must possess significant learning agility and must be able to get to the heart of issues succinctly and propose ideas with conviction
  
• Continuous improvement mind-set and disposition is critical
  
• Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies
  
• Ability to effectively present information and respond to questions from Executive Leadership team
  
• Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards (signal detection).
  
• Must be able to prioritize and multi-task with minimal supervision and participate in peer-review process when processing product complaints and adverse drug events.
  
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required. Lotus Notes experience preferred

Additional Information
Client offers an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Client is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
 

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