Manager of Quality Control in Bioassay

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Role Description

The successful candidate will assume the role of Manager in QC Bioassay, overseeing a team of both Scientists and Technicians. This key position requires a seasoned professional with a strong background in life sciences and extensive experience within the pharmaceutical industry.

You will be responsible for creating a positive and inspiring work environment, fostering a culture of excellence, and driving results-oriented initiatives. The role involves providing strategic guidance and drive the growth of your team, ensuring they have the necessary tools and resources to excel.

Key Responsibilities:

  • Team Management: Manage a team of Scientists and Technicians, providing guidance and support to ensure their success.
  • Priority Setting: Set clear priorities, motivate the team, and allocate tasks effectively to ensure seamless execution.
  • QC Coordinator Activities: Participate in training programs, interact with customers, and contribute to the development of QC Coordinator activities.
  • Reference Material Strategy: Establish a comprehensive strategy for Reference Materials, ensuring their timely availability and quality.
  • Control Material Supply Chain: Develop and maintain a reliable supply chain for Critical reagents, guaranteeing timely readiness and minimizing disruptions.
  • QC Deliveries and Batch Release: Oversee QC deliveries, ensuring compliance and adherence to regulatory requirements.
  • Customer Audits and Regulatory Inspections: Collaborate with cross-functional teams to prepare for customer audits and regulatory inspections.
  • QC Bioassay Compliance: Ensure that QC Bioassay operates in full compliance with regulatory standards.
  • Release and Stability Testing: Support Managers from other QC Bioassay teams in release and stability testing, promoting seamless collaboration.
  • Continuous Improvement: Drive continuous improvement initiatives, focusing on process optimization and the adoption of new technologies.

About the Ideal Candidate

We are seeking an exceptional individual with a strong background in life sciences and extensive experience within the pharmaceutical industry. Your expertise should include analytical development or Quality Control, with a proven track record as a leader, preferably in a GMP environment.

  • Leadership Experience: Proven leadership experience, preferably in pharmaceuticals, biotech, or related fields.
  • GMP Mindset: A strong GMP mindset and experience working in a GMP environment.
  • Communication Skills: Excellent communication skills, with a service-minded attitude and ability to build relationships with stakeholders across the organization.
  • Bioassay Methods Knowledge: In-depth knowledge of Bioassay methods.
  • Reference Materials Control: Familiarity with controlling reference materials.
  • Fast-Paced Environment: Ability to navigate a fast-paced environment, juggling deadlines and tasks with finesse.
  • Adaptability: Flexibility to adapt to evolving business needs and priorities.
  • Continuous Improvement: Interest in continuous improvement and process optimization, with a focus on new technologies and automation.

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