Job description

Manager – Quality Operations

Company Background

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include vasopressin, PEMFEXY™, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.

Eagle Pharmaceuticals is looking for a Manager of Quality Operations to assist quality management in the administration and management of quality-related activities for Eagle Pharmaceuticals with particular focus on Quality Operations.

Responsibilities

• Assist quality management in performing audits and supplier management specifically focusing on quality operations and product controls at third party suppliers
• Maintain the global supplier management database for all products

• Auditing (GMP, GLP, GCP)
• CMOs, CROs, APIs, TPLs, Laboratories, and other suppliers

• Assist with field and site inspection, contacts with the FDA, other Federal, state and local agencies and international regulatory bodies as directed by Quality management.

Qualifications

• Minimum BA/BS, in Chemistry, Biology or Pharmaceutical Science
• 6-8 years in the pharmaceutical industry.
• This individual must possess strong technical writing skills.
• Position requires a thorough knowledge and understanding of GMPs, GXPs, federal laws and regulations pertaining to the production and development of pharmaceuticals.
• Experience in internal and external auditing of GMP, GCP and GLP operations as well as batch record reviews.
• Experience in managing and operating computerized validated quality systems, including specifications, change control, documentation, deviations, training, complaints, CAPA etc.
• A thorough knowledge of CMO facility's equipment procedures and controls used in pharmaceutical production and analytical analysis.
• Excellent communication and negotiation skills.
• Ability to travel domestically and internationally (approximately 35%)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Type: Full-time

Pay: $125,000.00 - $135,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Experience:

• Pharmaceutical: 5 years (Preferred)
• GMP, GXPs, federal laws: 5 years (Preferred)
• CMO: 5 years (Preferred)
• Sterile Injectable: 5 years (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: One location

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