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Manager Quality (EM)
Manager Quality (EM)Grifols, S.A • Clayton, NC, US
Manager Quality (EM)

Manager Quality (EM)

Grifols, S.A • Clayton, NC, US
6 days ago
Job type
  • Full-time
Job description

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce, and market innovative medicines, solutions, and services in more than 110 countries and regions.

Summary :

Responsible for managing all aspects (i.e., quality systems, documentation, laboratory operations, compliance, training, staffing, and budgetary needs, etc.) of the Quality Control (QC) Environmental Monitoring laboratory.

Primary responsibilities for role :

  • Manage all aspects of a Quality Control business unit (quality systems, documentation, laboratory operations, overall compliance, oversee department budget, employee relations, etc.).
  • Follow cGMP and department safety practices.
  • Provide guidance and consult with manufacturing and internal regulatory departments on GXP matters.
  • Use expertise and sound judgment to make independent decisions within defined areas of responsibility.
  • Plan and analyze workflow, delegate, and prioritize to ensure that assignments and projects are completed in a timely manner and within budget.
  • Participate in regulatory and internal inspections / audits, including providing written responses as applicable.
  • Investigate and initiate corrective actions for quality-related issues.
  • Demonstrate high levels of value and integrity.

Key Task List :

  • Manage all aspects (quality systems, documentation, operations, compliance, budget, employee relations) of the QC Environmental Assurance business unit, including environmental monitoring of facilities, utility systems, and fill lines.
  • Author and / or approve department SOPs, perform investigations, write reports, initiate and approve changes to department processes through change control management system, and lead continuous improvement projects.
  • Serve as system administrator for Environmental Assurance laboratory control systems such as SAP to ensure EM results and test data are available for site personnel for timely reporting.
  • Serve as SME regarding environmental monitoring issues and collaborate with production and QA on projects, incident investigations, and reviews.
  • Participate in regulatory and internal inspections / audits, presenting site EM test and trending data, answering questions, and providing written responses.
  • Requirements :

  • PhD in Life Sciences or relevant degree with minimum of 6 years relevant experience, or MS with 8 years, or BS with 10 years.
  • Experience dealing with the FDA regarding license submissions, inspections, and audits.
  • Aseptic / sterile filling experience preferred.
  • Depending on the area of assignment, relevant experience or a combination of education and experience may be considered as equivalent.
  • We offer a comprehensive benefits package, including medical, PTO, bonus, pharmacy, dental, vision, disability, life & AD+D insurance, 5% 401K match, and tuition reimbursement. We are committed to professional growth and career progression. Despite being a global healthcare company, we pride ourselves on a family-like culture. Our workforce has more than tripled in the last 10 years — we're growing, and you can grow with us!

    Work is performed in an office environment with exposure to electrical equipment. Frequently sits for 6-8 hours, with occasional walking, bending, twisting, and light lifting. May require travel within the United States. Must communicate complex information clearly and work independently with minimal guidance. Ability to relate to diverse groups and apply abstract principles to solve complex issues.

    Third Party Agency and Recruiter Notice :

    Agencies must have an active, non-expired Grifols Agency Master Services Agreement and be engaged by a Grifols Recruiter to submit candidates. Resumes sent outside these terms will be considered Grifols candidates.

    Grifols is an equal opportunity employer, considering all qualified applicants without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, pregnancy, veteran status, disability, or other protected categories.

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    Quality Manager • Clayton, NC, US

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