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Associate Director, Quality Assurance – Sterile / Radiopharmaceutical Manufacturing

indiana, PA

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Job description

Associate Director, Quality Assurance – Sterile / Radiopharmaceutical Manufacturing

Location: Not specified

Posted: 1 week ago

Pay Range: $150,000.00/yr - $180,000.00/yr

We’re supporting a growing pharmaceutical manufacturer with a highly specialized platform, seeking an Associate Director of Quality Assurance to drive GMP compliance, QA systems strategy, and inspection readiness across complex manufacturing operations.

This is a standout opportunity for QA leaders with experience in sterile injectables, radiolabeled products, or time-sensitive GMP manufacturing environments .

Key Responsibilities:

Oversee QA operations across manufacturing, packaging, and batch record review

Lead investigations, root cause analyses, CAPAs, and change control processes

Manage QA support for radiolabeling or aseptic operations (as applicable)

Review and approve critical quality documentation (SOPs, protocols, reports)

Represent QA during regulatory inspections and internal/external audits

Develop team capabilities, manage department resourcing, and own quality KPIs

Ideal Background:

Bachelor’s degree in a scientific discipline

6+ years in QA/QC within GMP-regulated pharma or biotech environments

3+ years in a leadership role, with oversight of QA operations or systems

Familiarity with radiopharmaceuticals, sterile injectables, or short-shelf-life products is highly desirable

Experience with aseptic processing, batch release, and regulatory agency engagement

Why Join?

Competitive compensation and bonus eligibility

Full medical, dental, and vision benefits with employer contributions

401(k) with company match

Paid time off, holidays, and company-sponsored life and disability insurance

Strong training programs and professional growth opportunities

This is an opportunity to lead QA strategy at a highly dynamic, regulated site—ideal for those with radiopharma or sterile manufacturing experience looking to take the next step.

Contact: Phone/text:

Seniority level: Director

Employment type: Full-time

Job function: Quality Assurance

Industries: Pharmaceutical Manufacturing and Biotechnology Research

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Worksite address

indiana, PA, 15705, US

Who can apply

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