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Group Leader, Quality Assurance

Company: Boehringer Ingelheim Pharmaceuticals
Location: Athens
Posted on: March 13, 2023

Job Description:

Job Description - Group Leader, Quality Assurance (2216065) 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. Group Leader, Quality Assurance - 2216065 Description: 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 is 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. As requested by the manager conducts or assist with performance evaluations and development discussions.
  • As assigned, lead and 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, from an accredited institution, in a relevant scientific discipline, required.
    • Minimum five (5) years of related experience and/or training in a Manufacturing environment in Quality Assurance, Quality Control, Sterility Assurance, Engineering, Production, or Qualification / Validation, required.
    • Must have appropriate knowledge and good understanding of quality activities related to pharmaceutical manufacturing process; Examples include: 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 aspects of sterility assurance (i.e. environmental monitoring, aseptic process simulations or media fills, 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 to quality operations and compliance.
    • Training and work experience in root cause analysis tools preferred.
    • Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications. 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. 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, 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.

Keywords: Boehringer Ingelheim Pharmaceuticals, Athens , Group Leader, Quality Assurance, Other , Athens, Georgia

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