Description

Job Description

Who We Are:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:

We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

About the Role:

We are seeking a Manager, Quality Assurance, Supplier Qualification to join our team. The Manager, Quality Assurance, Supplier Qualification will support with developing and implementing a GxP audit plan. This also includes various audit activities and maintaining training records.



This position reports to the Director, Quality Assurance, Systems and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience. Relocation and immigration support will be provided, if required.



RESPONSIBILITIES:

• Support development and implementation an annual GxP audit plan in coordination with applicable functional areas
• Support selection of external auditors as applicable
• Maintain training records, CVs, SOPs, etc. of external auditors
• Ensure audits are scheduled per the audit plan
• Review audit reports as applicable to assure they are clear and cover the most important information to support successful development of CAPA's
• Prepare audit performance metrics to assure audit program is conducted per standards and SOPs
• Manage supplier performance scorecards and present supplier quality metrics to cross-functional stakeholders
• Perform trending of audit findings to assist QA and organization in identifying potential risks and supporting continuous improvement
• Assure audit plans, reports, CAPAs and certificates are appropriately archived
• Support supplier qualification activities including review of questionnaires and vendor approvals
• Manage and maintain GxP Quality Technical Agreements
• Evaluate Audit and Inspection Program processes for continuous improvement
• opportunities
• Support Xenon's GxP Quality System projects, programs and functional area initiatives as required
• Support ongoing inspection readiness activities, as needed

QUALIFICATIONS:

• Bachelor's degree in life sciences, or engineering with minimum 5 years of experience in the pharmaceutical or biotechnology industry
• Minimum 2 years of GxP QA Audit and/or Regulatory Inspection experience (GCP experience a plus)
• Knowledge and demonstrated experience in the applicable GXP regulations, FDA Good
• Manufacturing and Clinical Practices, ICH Guidelines, and Computer System Validation
• Experience in the conduct and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the company, to subject protection and data integrity
• Demonstrated ability to effectively organize and execute tasks
• Strong verbal and written communication (including presentation) and customer management skills

The base salary range for this role is $91,080 to $142,563 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.

Qualifications:

Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.

Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.

US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.

To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.