Senior Manager, Quality Assurance (Contract)

  • Company:
    Xenon Pharmaceuticals Inc.
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    16 hours ago
  • Category:
    Technology

Job Description

Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy. 

Xenon has a number of promising therapeutics in clinical development, valuable collaborations with pharmaceutical partners, and innovative early-stage research underway and also has a strong balance sheet to support its continued growth in 2021 and beyond. 

We are a collaborative, ambitious, and driven team with a common mission to improve the lives of patients with neurological disorders. Creating a healthy and productive work environment is a priority, and we understand the importance of investing in our employees’ growth and development. We support charities and volunteerism, knowing that when our people contribute to their local communities, they are gaining new experiences and becoming even better leaders. Xenon’s employees are smart, passionate, and driven by their incredibly important work to discover, develop and deliver new medicines for patients in need. We are looking for talented and determined individuals who thrive in a fast-paced and dynamic work environment to join our team during this transformative time for the company. If you want to learn more about job opportunities at Xenon, please visit www.xenon-pharma.com  

Xenon is seeking a Senior Manager, Quality Assurance to join our team. We are building the Quality function to support Xenon’s late stage clinical development programs and prepare for commercialization, as well as expand quality initiatives across the company. The Senior Manager will be a key contributor to manage quality aspects of GMP manufacturing, working autonomously and collaboratively within multidisciplinary teams.

This is a temporary full time position for 9-12 months, potentially leading to a permanent full-time position at Xenon’s Burnaby, BC facility or as a remote work arrangement from other locations in BC or Ontario for an exceptional candidate.

RESPONSIBILITIES:

  • Build upon and manage Xenon’s CAPA and quality risk management systems to enable the timely identification, resolution and communication of compliance risks, including quality metrics and trends to foster continuous process improvement.
  • Initiate and lead the review and execution internal and external change controls, as applicable.
  • Establish strategic risk-based review processes for GMP documentation by identifying key elements such as critical quality attributes, critical process parameters, and critical material attributes.
  • Contribute and manage Xenon’s quality systems and activities including: document control, records management, change control, nonconformance/deviation management, internal and external audits, GxP training programs, and inspection readiness.
  • Support computer systems validation and assist with the management of Xenon’s electronic quality and document management systems.
  • Provide GMP compliance interpretation, consultation, training, and other support necessary to maintain and improve quality processes to ensure product quality, the protection of human participants’ safety, rights and well-being, and the integrity and credibility of data generated.
  • Participate in regulatory inspections held at Xenon’s offices or vendor facilities, as needed.
  • Establish and manage effective cross-functional team communications and effectively impart advice on strategy and implementation of quality principles as well as regulatory requirements while remaining independent.

QUALIFICATIONS:

  • Minimally, a bachelor’s degree from an accredited institution in a scientific or health field with at least 10 years of direct, relevant QA management experience, or comparable background of relevant QA experience in late-stage clinical development in the biopharmaceutical industry. Quality experience with commercial products an asset.
  • Solid knowledge and experience with global GxP principles and applicable regulations from GLP through to GDP and GVP, with a particular emphasis on global GMP regulations and guidelines, current industry standards, best practices, methodologies.
  • Experience with establishing, managing and utilizing electronic document and/or quality management systems.
  • Good understanding of the drug development process and the interdependencies between QA and other functional areas.
  • Strong organizational skills to effectively prioritize and manage several complex projects in parallel and within established timelines.
  • Proficient in the conduct of audits and the translation of findings into CAPAs that mitigate risks.
  • Proven ability to work independently and collaboratively as part of a multidisciplinary team.
  • Proficient negotiation and conflict resolution skills.
  • Clear, concise and professional communication skills.

To apply for this position, please visit https://can59.dayforcehcm.com/CandidatePortal/en-us/xenon, select the position you are interested in, click Apply Now to create a candidate profile, and complete the job application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for an interview will be contacted.