_Principal Specialist, Supplier Quality Management

Boehringer Ingelheim • Gainesville, GA • 9h ago

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 a number of 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.

The Principal Specialist, Supplier Quality Management performs active quality management and quality oversight of the site's GxP-relevant material and service suppliers, including clinical and commercial GMP contract manufacturing and contract laboratory organizations. The role executes procedures that ensure procured materials and services meet Boehringer Ingelheim Quality System expectations, Quality Assurance Agreements, client requirements, and health authority standards. The Principal Specialist, Supplier Quality Management proactively resolves issues arising during job execution in alignment with approved procedures.

Duties & Responsibilities

Participates in the creation of team standard operating procedures and uses applicable computerized systems to execute assigned tasks.

Manages quality oversight of GxP-relevant materials, services, and suppliers, including CMOs and CLOs, across all phases of the supplier lifecycle (on-boarding, audits, maintenance, termination).

Generates, reviews, negotiates, and maintains Quality Assurance Agreements with CMOs, CLOs, suppliers, and inter-company partners.

Supports supplier, CMO, and CLO selection and (re)qualification, including manufacturing and analytical transfers and material certification activities.

Acts as a quality-responsible person and first escalation point, providing guidance to resolve quality issues related to suppliers, materials, and services.

Escalates issues per approved escalation policies to resolve conflicts promptly and minimize business risks.

Investigates deviations in alignment with procedures and collaborates cross-functionally to deliver timely and adequate investigations.

Manages assigned changes including supplier notifications and process changes that may affect product quality or regulatory compliance.

Serves as a site subject-matter expert, remaining current on applicable procedures and integrating site needs into global platforms, forums, and projects.

Ensures active participation in identifying, sharing, and adopting shared practices across BI sites and supports continuous improvement initiatives.

Establishes performance-monitoring measures for CMOs, CLOs, suppliers, materials, and services, including KPIs, follow-up methods, and onsite performance reviews.

Drives timely escalation and resolution of high-risk events and contributes corrective actions and system improvements.

Prepares documentation supporting regulatory submissions, participates in readiness activities for audits and inspections, and represents the site during inspections.

Requirements

Bachelor's degree in a scientific or technical discipline.

At least 5 years of experience in life sciences or a closely related industry.

Strong systems skills, including SAP and GoTrack.

Experience evaluating supplier and material quality and supporting supply chain activities.

Experience working in a fast-paced, customer-focused environment.

Knowledge of industry standards, regulatory expectations, and compliance requirements.

Ability to improve local and global standards and drive continuous improvement.

Strong oral and written communication skills.

Ability to motivate and mobilize staff.

Strong attention to detail, rapid learning ability, and strong computer proficiency.

Ability to read and develop procedures and controlled documents.

Strong interpersonal skills to build highly functional cross-functional relationships.

Ability to work effectively in a team environment with high energy and self-motivation.

Demonstrated proficiency in MS Office and related systems.

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.

Desired Skills, Experience and Abilities

All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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