Manager/Senior Manager, Clinical and PV Quality

Regulatory Toolkit; New York (NY); In loco; USD 120.000 - 140.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Equity

Generous benefits

Descrizione del lavoro

Axsome Therapeutics is seeking a Manager/Senior Manager Clinical and PV Quality to provide GCP and GVP oversight of Axsome’s clinical trial activities and related records to assure quality and regulatory compliance.

The role will lead cross-functional quality efforts, manage audits, and drive training and inspection readiness, reporting to the Senior Vice President, Quality. This on-site NYC position requires three days per week in the office.

Competenze

• Bachelor’s degree in a scientific discipline.
• 5+ years in pharma/R&D with hands-on GCP/GVP QA experience.
• Experience in compliance and regulatory inspections.

Mansioni

• Provide GCP and GVP oversight for Axsome’s clinical trials and related records.
• Lead audit programs and ensure inspection readiness across functions.
• Develop training on GCP/GVP requirements for trial teams.
• Identify compliance risks and implement mitigations.
• Collaborate with Clinical Operations, Pharmacovigilance and Medical Affairs.
• Escalate issues to senior management and maintain documentation.

Conoscenze

GCP QA

GVP QA

Quality Assurance

Formazione

Bachelor’s degree in a scientific discipline

Strumenti

MS Office

Descrizione del lavoro

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs byidentifyingcritical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

AboutThis Role

AxsomeTherapeutics isseekingaManager/Senior Manager Clinical and PV Quality who will provide Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) oversight of Axsome’s clinical trial activities and related records and processes to assure quality and management in accordance with key global regulations (FDA, Health Canada, EMA and MHRA), ICH guidance (GCP E6, E2 and other relevant guidelines), company processes (such as SOPs) and all other applicable regulations.

The Manager/Senior Manager Clinical and PV Quality will manage cross functional relationships with internal and external stakeholders and be the lead Quality GCP and GVP representative on clinical teams for ongoing Axsome-sponsored trials and post-market activities.

This position will report tothe Senior Vice President, Quality.

This role is based atAxsome’sHQ 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.

Job Responsibilities and Duties

• Partner with key functions (Clinical Operations, Pharmacovigilance) and interface functions (e.g. Medical Affairs and Commercial) to support a compliance journey; driving and achieving a “first time right” approach in relevant issue and initiatives.

• Support the development, implementation, and improvement of corporate quality systems that support early,midand late phase clinical programs and post marketing activities.

• Provide GCP / GVP requirements input into the development and implementation of Quality (GxP) systems.

• Providesexpertiseand guidance on applicable regulations to specialty pharma/clinical development and pharmacovigilance teams, to proactivelyidentifycompliance issues/risks and recommend mitigation.

• Identifyand address GCP / GVP compliance issues across Axsome clinical and pharmacovigilance systems and processes to ensure a state of readiness for regulatory inspection.

• Develop and implement a risk-based GCP and GVP audit program.

• Execute GCP / GCP-GcLP/ GVP internal audits (i.e. adherence to SOPs, company policies, and regulations/standards) or external audits (adherence to contractual agreements,plansand regulations / standards).

• Develop and facilitate GCP/GVP/GXP training for functional areas and personnel involved in the execution of clinical trials and post marketing activities.

• Identify,monitorand report compliance trends and risks for trials and post market activities.

• Lead and support investigations into significant departures from GVP / GCP, including serious breaches / scientific misconduct.

• Escalate compliance issuesidentifiedto senior management.

• Review and provide input to clinical documentation (e.g. protocols, study reports, IB etc.)

• Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance, and Pharmacovigilance systems and standards.

• Develop and measure GCP and GVP quality metrics to drive consistent quality standards throughout the organization. Maintain relevant knowledge of appropriateGxPrequirements and developments as theyimpactcompany SOPs and compliance withGxPand communicate these to the QA team and QA management, as applicable.

• Provide information relating to Quality to stakeholders, asrequired(e.g. PV System Master File).

Requirements/ Qualifications

• Bachelor’s degree in a scientific discipline or field

• 5+ yearsof experiencewithin the pharmaceutical and R&D industry, of which a minimum of3years hands-on GCP and/or GVP QA experience.

Experience,Knowledgeand Skills

• Experience in a compliance role.

• Extensive knowledge and practical application of ICH, GCP /GVPand applicable guidance documents.

• Ability toidentifyproactively andanticipaterisk of non-compliance in a complex environment.

• Experience of hosting or managing GCP and/or GVP inspections is desirable.

• Experience in clinical operations and handling trial essential documents is preferred.

• Proficient MS Office skills.

• Excellent planning and organizational skills.

• Exceptional attention to detail.

• Strong interpersonal skills and a team player.

• Ability to influence senior leaders within the organization on matters of quality importance.

• Effective communication skills, both verbally and written.

• Proven ability to manage complex projects.

Salary & Benefits

Theanticipatedsalary range for this role is$120,000 - $140,000.We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internalequityand location.Axsomeoffers a competitive employment package that includes an annual bonus, significantequityand a generous benefits package.

Axsomeis committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity andsolicitapplications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

AxsomeTherapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or otherAxsometeam members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System tosubmitcandidates for consideration.