The Quality Assurance Specialist (Complaints and Approval to Distribute) is a champion of accountability, agility, and intrapeneurship (AAI) behaviors and Quality Culture. This role ensures quality and compliance to regulations and internal procedures with respect to Complaint Handling and Approval to Distribute. The incumbent will assist as needed with Field Alert Reports (FARs), Biologic Product Deviation Reports (BPDRs), market actions, and Product Safety and Security. This role is responsible for ensuring that batches manufactured by Contract Manufacturing Organizations (CMOs) and BI OPUs for products to be distributed in the US meet the requirements for approval to distribute as well as responsible for escalating any critical events to Management in a timely manner.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

This role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site.

Duties & Responsibilities

• Partners with Third Party Quality Management (3PQM), Contract Manufacturing Organizations (CMOs), and BI OPUs to ensure that complaints are properly investigated and accurately documented within the global complaint system. Ensures the root cause or most probable root cause of reported complaint has been determined
  Collaborates with BI OPUs, 3PQM and CMOs as needed to review and/or recommend sustainable Corrective Action/Preventive Actions (CAPAs) to be implemented at impacted sites
  Reviews, approves/closes customer complaints ensuring that the investigation meets acceptable quality standards including but not limited to established time lines. Focus is on complaints with market action potential, however will also support closure of other complaint investigations as needed.
• Supports international Quality initiatives/projects:
  Acts as Local Pharmaceutical Complaint Officer (LPCO).
• Responsibilities include but not limited to:
  Ensuring that all complaints received at the local level are entered into the company's complaint system, categorized and assigned to the appropriate investigation site within established timelines including interaction with the complainant, the Corporate Pharmaceutical Complaint Officer and potentially with local health authorities; regularly performs complaint trending and issues complaint reports.
  Collaborates with other LPCOs and Deputy LPCOs on global continuous process improvement initiatives.
  Represents BIPI at internal and external forums on complaint management.
  Responsible for complaint trending evaluation, leads functional team meetings to ensure that Critical Events are known to local Quality management.
  Provides complaint data to and participates in monthly cross functional Quality Management Review (QMR) meeting and monthly 3PQM QMR to ensure site is aware of complaints within US Marketed products
  Collaborates with others within Quality Assurance to ensure complaint process is of high quality and adheres to established time lines.
  Actively participates in alignment calls with BIPI-Ridgefield, HPSG, and Complaint MSO to drive continuous process improvements.
  Local contact partner/liaison for Brand Safety & Security initiatives
• Independently performs batch record review and/or final disposition of drug products manufactured by CMOs and BI OPUs ensuring that the batch was produced in compliance with specifications, cGMPS and corporate policies and procedures.
• Possesses the authority to make batch disposition (approval to distribute, reject) decisions and address non-standard events and documentation errors with CMOs. Errors in decision making can result in market action such as product recall and/or interruption in the supply chain, therefore ability to meet the market demands.
• Prioritizes work to ensure no interruption to supply chain. First line of contact for escalation of potential problems with product or meeting market needs. Escalates to management any potential interruption to the supply chain when recognized.
• Acts as a representative on cross-functional teams that require batch disposition input. Investigates and resolves inter-company deviations that impact batch prior to disposition.
• Completes the ERP transactions associated with the batch decision.
• Travel as required for position and assigned projects/tasks. Domestic and International travel ~20%

Requirements

• BS/BA in Chemistry, Pharmacy, or related science Diploma with additional years of experience.
• Minimum five (5) years’ experience with BS/BA pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
• Diploma and seven (7) years’ experience in pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
• Ability to respond and act appropriately with all levels under time pressure and regulatory scrutiny. For example, ability to evaluate quality issues and make strategic decisions to minimize the quality and business impact of product batches and campaigns. Escalates and collaborates with quality management to resolve trends impacting product quality.
• Demonstrated knowledge of FDA, cGMP, EU regulations, and USP. Emphasis on management of current good manufacturing practices programs.
• Demonstrated effectively applying cGMP and quality system regulations within the pharmaceutical industry.
• Demonstrated knowledge of Quality Assurance, Production, Laboratories or Regulatory functions within a pharmaceutical environment.
• Excellent communication skills with the ability to influence/persuade individuals.
• Ability to utilize active listening skills to understand the concerns or reasoning to be responsive, gain trust, and build strategic relationships.
• Project management expertise to arrive at quality effective and efficient processes that contribute to product quality.
• Experience using Microsoft applications (Word, Excel) and ERP is preferred.
• Demonstrated investigative techniques to uncover problem areas and recommend corrective actions.
• Problem solving ability requiring attention to detail, accuracy, cGMP, and scientific judgment.