Specialist IV, 3rd Party Quality Management

Description

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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Specialist IV, 3PQM is responsible for Quality management of all third-party manufacturing activities at CMOs assigned to 3PQM NA network in order to ensure that current GMPs and relevant regulatory requirements are followed. The incumbent ensures that the quality management system is being followed and maintained within 3PM NA in line with the BI pharmaceutical quality system (PQS) and regulatory expectations.

The Specialist IV, 3PQM ensures that process and systems that have potential impact on BI products quality are validated and maintained. The position holder also ensures regulatory compliance and high-quality standards of products manufactured at the assigned CMOs (contract manufacturing organization). The incumbent maintains full product risk oversight and proactively drives risk reduction.

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

Duties & Responsibilities

• Reviews and approves internal and external deviation reports and CAPA's.
• Manages reporting and timely closure of customer complaints, deviations, and CAPA.
• Ensures effective root cause analysis (RCA) is conducted and that the CAPA process at the CMOs is implemented effectively.
• Manages and approves changes that can have an impact on either material, equipment, documentation, and/or formulation for products.
• Represents 3PQM NA in cross-functional meetings such as technology transfer projects, launch and NBO (new business opportunity) projects.
• Performs due diligence PDR's ((product design review), join technical visits at CMO's.
• Leads quality expert meetings, annual CMO ratings and Business Review Meetings.
• Identifies risks, proposes, and implements risk mitigation measures.
• Supports business in the assigned region in setting up quality relevant contracts, both for contract manufacturing and other business models (e.g., co-marketing, co-promotion, out-licensing) to support product launches and new business opportunities.
• Serves as the responsible Quality contact at the assigned CMOs\out-licensees and first point of escalation to resolve quality issues with CMO\out-licensees and at BI/CMO interface.
• When necessary, escalates issues to the Head of 3PQM NA to resolve conflicts promptly and minimize risk to the organization.
• Provides support to the Head of 3PQM to ensure that effective and efficient quality systems are implemented and maintained within the Organization.
• Writes, updates and reviews SOP’s to ensure congruence with good manufacturing practice (GMP) and BI PQS and quality manual.
• Supports the update of the Quality system and ensures that it is applied and that all activities are performed according to the local Quality System and SOP’s.
• Assumes responsibility as local Management System Owner for defined quality systems.
• Contributes to the monthly Quality Management Review (QMR) meeting of 3PQM NA; Presents relevant Quality topics as required.
• Supports the product quality review (APR/PQR) activities for the assigned products\CMOs by assessing the PQR for product trends that may need to be addressed.
• Ensures that the APR/PQR is performed in accordance with the approved procedure and schedule.
• Provides support to all activities associated with product market actions e.g., recalls according to the BI Quality requirements and local procedures.
• Acts as 3PQM NA /CMO representative in LAC/CAC (Local Advisory Committee / Corporate Advisory Committee) meetings.
• Responsible for batch review and release, approval of master batch documents, product specifications, validation reports and any other miscellaneous documents associated with batch production.

Requirements

• Bachelor’s degree with a focus in Chemistry and/or Pharmaceutics.
• Other degree focuses acceptable with appropriate experience.
• Nine (9) years of experience in a regulated, pharmaceutical environment with a minimum of three (3) years of quality assurance experience.
• Prior experience in quality oversight of 3rd party suppliers is desired.
• Communication, negotiations, relationship building, influence, time management, problem solving.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.