Specialist IV, Supplier Quality Assurance
US-BI Pharma/BI USA
 Columbus, OH

Description:

Responsible for the overall management of BIPI Supplier Management Program

from qualification through lifecycle in support of supply chain integrity and continuity (Management System Owner Responsibility). Responsible for comprehensively evaluating the supplier’s regulatory/cGMP compliance, monitoring supplier use restrictions, remediation activities when necessary and assessing suitability of Corrective Actions and Preventive Actions (CAPAs) with Suppliers that provide product to the US Market.

Responsible for Quality management of Repackaging activities (Primary or Secondary) in order to ensure that current GMPs and relevant regulatory requirements are followed. Ensures that the quality management system is being followed and maintained at third-party Repackager(s) in line with the BI pharmaceutical quality system (PQS) and regulatory expectations.

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

Duties & Responsibilities:

  • Leads a cross-functional team through the supplier management process from qualification through lifecycle monitoring. Typical tasks may include, but not limited to:
    • Providing information regarding supplier audits, and certification status.
    • Collaborates and partners with Audit Center of Excellence and/or 3PQM to provide audit connectivity or closures on Supplier CAPAs when necessary.
    • Maintaining the site approved material/services supplier list.
    • Monitoring the supplier’s status and performance metrics.
    • Maintain Annual Supplier Audit Schedule.
  • Oversees and monitors Supplier CAPA management
    • Ensures that an effective internal deviation and CAPA system is established and maintained at Supplier's facilities.
    • Partners with 3PQM to ensure that an effective internal deviation and CAPA system is established and maintained at CMOs and BI OPUs that manufacture product for the US Market.
    • Escalates supplier quality trends resulting from deviations and CAPAs to provide transparency to management.
  • For Third party Supplier Services (i.e. Repackaging Operations), serves as the responsible Quality contact and first point of escalation to resolve quality issues. Supports business in setting up quality relevant contracts.
  • For Repackaging Operations, specific responsibilities include, but are not limited to:
    • Approval of master repackaging documents, product specifications.
    • Authorize shipment of components to repackaging site.
    • SAP Quality-transactions associated with repackaging operations.
    • Review completed batch and other miscellaneous re-packaging documents associated to authorize product shipment back to BIPI and Approval to Distribute.
  • Drives Continuous Improvement
    • Monitors industry activity, global regulatory changes and corporate requirements and evaluates impact to BIPI supplier management program.
    • Partners with ACE, 3PQM for effective collaborations for Supplier Audits, Outcomes, Risk Management etc.
    • Conducts quality system audits.
    • Partners with Repackager(s) to resolve GMP/GDP compliance issues.
    • Ensures processes are in compliance with regulations and corporate procedures.
    • Ensures procedures are in compliance with applicable regulations.

Requirements:

  • Bachelors degree from an accredited institution with focus in Pharmaceutics or Chemistry.
  • Other degree focus may be acceptable with appropriate experience.
  • Minimum five (5) years of experience leading projects/project teams, with at least three (3) years of Quality Assurance experience.
  • Knowledge of FDA, cGMP, EU regulations.
  • Possess excellent communication skills with the ability to influence cross-functional teams.
  • Functional expertise in auditing, inspections is desirable.
  • Product and market knowledge is beneficial to better access suitability of a supplier and to evaluate product impact when supplier issues/risks are known.
  • Ability to successfully lead/manage multiple tasks at differing depths of knowledge.

Desired Experience, Skills, and Abilities:

  • Experience within regulated environment, preferably pharmaceuticals.

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.

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; 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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