Quality Assurance Group Leader

The Quality Assurance Group Leader will lead their QA release group in order to support their associated production team as required through batch documentation review, deviations, change controls, CAPAs, and document creation/revision in compliance with procedures and regulatory requirements. Responsible for annual review of regulatory documents, the internal audit program, and providing production support as needed.

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

• Product Release: Oversee the review/approval of manufacturing records, test reports, daily log books data capture forms, deviations, product holds/dispositions, change controls, CAPAs, document creation/revision, etc. as needed to release product according to applicable procedures.
• Regulatory Compliance: Lead the team to ensure routine production aligns with regulatory compliance for USDA and other countries as applicable. This includes conducting annual review of regulatory documents.
• Audits: Execute assigned internal audits as required.
• Production Support: Act as SME for routine production issues leading towards deviations, product dispositions, and response corrections needed to continue production.
• Supervisor areas: Lead a team of QA professionals through daily operations. Conduct or assist with performance evaluations and development discussions.
• Manage a quality system within the department (i.e., facility document revisions, media fill program, gowning qualification program, cleaning program, etc.).
• Hold team accountable to all related USDA, international, and GMP Biologics requirements at the Athens site for maintaining product registrations in >90 countries.

Requirements

• Bachelor’s degree in a relevant scientific discipline.
• Minimum five (5) years of related experience in a Manufacturing environment in Quality Assurance, Quality Control, Sterility Assurance, Engineering, Production, or Qualification/Validation.
• Appropriate knowledge of quality activities related to pharmaceutical manufacturing process, including product release, batch record review, root cause analysis, change control.
• Functional knowledge of product manufacturing activities is required.
• Functional knowledge of USDA requirements for biologic production is recommended.
• Experience with bioreactors, parenteral filling lines, freeze dryers preferred.
• Experience with licensed biopharmaceutical or biological products preferred.
• Experience with sterility assurance (i.e., environmental monitoring, aseptic process simulations, water systems, aseptic technique, etc.) preferred.
• Experience in an FDA and/or USDA regulated industry preferred.
• Fully versed in GMP’s, FDA, USDA, European and other regulatory agency requirements sufficient to comply with quality operations and compliance.
• Training and work experience in root cause analysis tools preferred.
• Computer skills in Microsoft Office applications and the ability to learn new applications.

Desired Skills, Experience and Abilities

• Excellent leadership and team management skills.
• Strong communication and interpersonal skills.
• Ability to work independently and handle multiple tasks simultaneously.
• Problem-solving and analytical thinking skills.