Manager/Senior Manager, QA Operations
About The Position
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. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Requirements
- 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
Responsibilities
- 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
Benefits
- annual bonus
- significant equity
- generous benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Senior
