Manager/Senior Manager, QA Operations

About Axsome Therapeutics Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians.

Axsome Therapeutics

BiopharmaceuticalsPainCNSNarcolepsyMajor Depressive DisorderAlzheimer's Disease AgitationFibromyalgiaSmoking CessationMigraineand Attention Deficit Hyperactivity Disorder

A

axsome.com

201-500 employees

Biotechnology Research

New York, NY

2012

Public Company

44k LinkedIn followers

Raised $1.1B

• Bachelor of science degree highly preferred, preferably in a scientific discipline
• At least 6 years of experience working in a pharmaceutical QA function with 3+ years of QA management/oversight of contract operations
• Up to 20% domestic and international travel may be required
• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
• 1+ years managing/supervising a QA team is preferred
• Experience working with CDMOs and relationship management preferred
• Strong hands-on knowledge of API and drug product (oral solids) manufacturing processes
• Strong knowledge of FDA/EEA/HC regulations, ISO and other applicable quality standards
• Strong attention to detail and excellent organization skills
• Excellent interpersonal, communication (verbal/written) and negotiation skills
• Comfortable multi-tasking in a fast-paced small company environment and able to navigate through ambiguity and rapid growth and adapt to change
• Proven track record of success in developing and implementing quality policies and procedures, conducting audits and leading cross-functional teams

• The anticipated salary range for this role is $125,000 - $140,000. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.