Site Quality Head, Indianapolis Isotopes Site
2 weeks ago
Job Description Summary
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 provide quality assurance oversight and technical and strategic leadership for all quality-related matters.
Key Responsibilities:
- Support site start-up, expansions, and product transfers by creating and maintaining updated project plans to track progress and ensuring 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 as a team member or team leader.
- Lead the Quality department, ensuring that team members are qualified, motivated, and carry out their duties in a safe manner.
- Work with internal and external personnel to create user requirements and specifications for projects in compliance with company standards for equipment, process, and facilities.
- Ensure that facilities, utilities, and equipment are designed and installed to be operated in a safe and effective manner and are compliant with applicable standards.
- Ensure that project phase planning, construction, commissioning, qualification (IQ, OQ, and PQ), and validation activities comply with cGMP.
- Escalate risks in meeting timelines and/or budget, incorporating site master planning and the long-term strategic plan.
- Manage product critical quality issues (deviations, out of specifications), ensuring investigations are correctly executed and adequate CAPAs are defined and followed up on.
- Define, implement, monitor, consolidate, and analyze Site Quality KPIs, ensuring the Site Quality Committee is established and relevant corrective and preventive actions are endorsed and implemented.
- Drive site management team accountability and coordinate the generation and execution of the Site Quality Plans, DI Plan, Site Quality Risk Assessments, and other relevant gap assessments.
Essential Requirements:
- Bachelor's degree in Life Sciences or related experience in lieu of degree, with 10 years of experience in GMP Pharmaceutical Manufacturing (including laboratory operations and Aseptic experience) and at least 3 years of relevant experience in Quality Control and/or Quality Assurance.
- Prior leadership experience, including experience working in a matrix organization, with highly developed management and communication skills.
- Demonstrated success managing inspections from major Health Authorities (e.g., US FDA, EMA), with in-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations.
- Proven ability to manage multiple projects with moderate resource requirements, risk, and/or complexity, with experience in process improvement approaches (Lean Six Sigma, Total Quality Management, 5S, etc.).
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