Site Quality Head, Indianapolis Isotopes Site

3 weeks ago

Indianapolis, Indiana, United States Novartis Group Companies Full time

At Novartis, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients.

We are seeking an experienced Quality professional to support site start up and Quality operations at our new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis.

As the Site Quality Head, you will be accountable for providing quality assurance oversight and technical and strategic leadership for all quality-related matters.

Key Responsibilities:

  • Support site start up, expansions, and product transfers.
  • Create and maintain updated project plans to track progress.
  • Ensure proper preparation and consolidation of the budget for the Quality Unit.
  • Provide leadership for strategic site initiatives and represent site SLT quality in local cross-functional and global projects teams.
  • Provide leadership, direction, and support to the people within the Quality department.
  • Work with internal and external personnel to create user requirements and specifications for projects.
  • Ensure all facilities, utilities, and equipment are designed and installed to be operated in a safe and effective manner.
  • Ensure compliance with cGMP during project phase planning, construction, commissioning, qualification, and validation activities.
  • Timely escalation of risks in meeting timelines and/or budget.
  • Ensure adequate management of product critical quality issues.
  • Define, implement, monitor, consolidate, and analyze Site Quality KPIs.
  • Establish and maintain the Site Quality Committee.

Essential Requirements:

  • BS in Life Sciences and/or related experience in lieu of degree.
  • 10 years of experience in GMP Pharmaceutical Manufacturing, including laboratory operations and Aseptic experience.
  • At least 3 years of relevant experience in Quality Control and/or Quality Assurance.
  • Prior leadership experience, including experience working in a matrix organization.
  • Highly developed management and communication skills.
  • Demonstrated success managing inspections from major Health Authorities.
  • In-depth knowledge of cGMP, FDA regulations, and ICH regulations.
  • Understanding of United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and American Chemical Society (ACS).

Benefits and Rewards:

We offer a competitive salary range of $158,400.00 to $237,600.00 per year, as well as a comprehensive benefits package, including medical, financial, and paid time off benefits.

Novartis is an Equal Opportunity Employer and is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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