Manager/Senior Manager, QA Operations
Axsome Therapeutics
Summary
Axsome Therapeutics is seeking a Manager/Senior Manager, QA Operations, responsible for ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The Manager/Senior Manager, QA Operations will contribute towards the enhancement of Axsome quality processes and ensures appropriate QA oversight of suppliers (CDMOs and GMP-related service providers) contracted for the development, manufacturing, testing, shipment and/or distribution of API and finished products to assure compliance with company procedures, FDA/EEA/Health Canada regulations and assists with tasks necessary to achieve department and/or company goals.
Job description
Job Responsibilities and Duties
- Assist with development and/or implementation of corporate quality management systems that support clinical-stage R&D and commercial programs
- Interact closely with Quality Systems & Compliance to champion continuous improvement and garner corporate support for Quality Improvement Initiatives
- Support the development of key performance indicators (KPIs) to measure and report operational performance of CMOs, recommending data-driven decisions to optimize processes
- Responsible for all aspects of QA Operations, including review and approval of cGMP-related documentation (SOPs, batch records, validation protocols, technical reports, specifications, deviations, CAPA, change controls, APQR) and resolve discrepancies as needed
- Identify and address compliance issues to ensure Axsome’s QMS is maintained in a state of inspection readiness
- Serve as a Quality liaison between Axsome and suppliers
- Serve as an escalation point for CMO quality issues with regards to investigations, nonconformances, deviations, and CAPA
- Alerts senior management of significant quality, compliance and supply risks
- Collaborate with internal cross-functional teams to identify and address quality issues develop corrective action plans, and implement process improvements
- Collaborate with external partners, including suppliers, vendors, and regulatory agencies, to ensure that our products and services meet all quality requirements
- Develop, review or revise Standard Operating Procedures (SOPs), Work Instructions (WI) and other controlled documents
- Builds and maintains a robust Operations team by providing effective communication, motivation, mentorship and performance feedback
- Participate in vendor audits and site visits, as needed
Requirements / Qualifications
- 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
Experience, Knowledge and Skills
- 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
Requirements
- Bachelor of science degree highly preferred, preferably in a scientific discipline
- At least 6 years of experience working in a pharmaceutical QA function
- 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
- 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
- Proven track record of success in developing and implementing quality policies and procedures, conducting audits and leading cross-functional teams
Benefits
- Annual bonus
- Equity
- Generous benefits package
Company overview
Axsome Therapeutics is a biopharmaceutical company focused on developing and commercializing novel therapies for central nervous system (CNS) disorders. The company has built a robust pipeline targeting major depressive disorder, migraine, Alzheimer's disease agitation, and other neurological conditions. Axsome's lead product, Auvelity (dextromethorphan-bupropion), received FDA approval for the treatment of major depressive disorder in adults, representing a significant advancement in depression treatment with a novel mechanism of action. The company's development strategy focuses on leveraging known active pharmaceutical ingredients in novel combinations or formulations to create differentiated therapies with improved efficacy and safety profiles. Axsome employs a targeted approach to CNS disorders where significant unmet medical needs exist, combining scientific innovation with strategic clinical development to bring meaningful treatments to patients suffering from debilitating neurological conditions.