Sr. Director of Quality Operations
$220,000–$220,000 year
On-site · Ledgewood, New Jersey, United States
Job Summary
Sr. Director of Quality Operations to oversee day-to-day Quality Assurance and Quality Control at Harrow's Imprimis NJOF site in Ledgewood, NJ. Responsible for GMP/cGMP compliance, regulatory inspections, SOP adherence, batch release, CAPA, deviation investigations, data integrity, and QA/QC leadership. Leads and develops the quality organization, ensures readiness for audits, collaborates with Manufacturing, MS&T, Supply Chain, and Compliance, and supports regulatory authorities with inspections and inquiries. Requires extensive experience in sterile/non-sterile drug compounding under 503B, strong leadership and communication skills, and ability to manage complex quality decisions in a fast-paced, regulated environment.
Required Qualifications
- Bachelor's degree in Science or Engineering or related field or equivalent work experience required
- Master's degree preferred
- 10+ years of progressive leadership experience in a cGMP facility
- People management experience (20+ employees)
- Strong technical understanding of manufacturing, laboratory, and quality systems
- Proven leadership in regulatory inspections and complex quality decision-making
- Ability to balance compliance, operational efficiency, and business priorities
- Experience with aseptic drug product bulk manufacturing process preferred
- Autonomous task completion with minimal direction
- Strong written, verbal, and presentation communication
- Strong computer skills (Word, PowerPoint, Excel) and ability to learn new software
- Ability to work under pressure, meet deadlines, and exercise sound business judgment
- Ability to influence without direct authority
- On-Site role with travel up to 10%
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