Senior Manager/Associate Director, Quality Assurance, GCP

Xenon Pharmaceuticals•Needham, MA

1d•$145,700 - $213,400•Hybrid

About The Position

We are seeking a Senior Manager/Associate Director, Quality Assurance, GCP to join our team. We are building our Quality function to support Xenon’s clinical development programs, as well as expand quality initiatives across the company. This person will provide Quality support primarily in support of early-stage clinical programs (pre-phase 3). This position will support inspection readiness initiatives to ensure compliance within the R&D Program. The successful candidate must have a solid Clinical Quality background, including providing Quality support for study teams, auditing, and inspections. The ideal candidate will be someone who is data-driven and focused on the science of early phase clinical development. Experience in GLP regulations is a plus. This position must have proven interpersonal skills, excellent communication skills, and a collaborative and pragmatic approach to Quality. This position reports to the Director, Quality Assurance, GCP and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week.

Requirements

Bachelor’s degree in a scientific or health field with at least 8 years of GxP QA experience, 6+ years GCP QA, supporting both development and commercial programs in the pharmaceutical or biotechnology industry.
A minimum of 3 years in a quality lead role in a pharma or biotech environment. Job level commensurate with years of experience.
Extensive knowledge of GCP regulations, guidelines, current industry trends, standards, and methodologies.
Sound knowledge of GLP regulations, guidelines, current industry trends, standards, and methodologies.
Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA) is desirable.
Strong understanding of all phases of the drug development process and the interdependencies with other functional areas, but experience in early phase (pre-phase 3) is required.
Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks.
Ability to effectively prioritize and manage multiple complex projects in parallel and successfully achieve critical milestones and expected deliverables within established timelines and budgets.
Must be able to demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having willingness to do the work to achieve goals.
Demonstrated ability to interact professionally and communicate clearly, concisely, and consistently both verbally and in writing with internal and external stakeholders.
Proven ability to work independently and collaboratively as part of a multidisciplinary team.

Nice To Haves

Experience in GLP regulations is a plus.

Responsibilities

Serve as the quality representative for assigned early phase clinical programs to include activities such as development and maintenance of Quality Plans, facilitation of study quality risk assessments and oversight of Critical to Quality Factors and Quality Tolerance Limits.
Support quality oversight of GLP programs, including the audit program activities, collaborating with Quality Systems to support development of the annual audit plan.
Provide GLP/GCP compliance interpretation, consultation, training, root cause analysis, and other supportive services necessary to maintain and improve the quality of the Company’s R&D programs to safeguard study participants’ safety and rights and ensure the quality, integrity, and credibility of data generated.
Identify and escalate critical quality issues appropriately to QA Management.
Assist with the preparation and support of regulatory inspections held remotely and onsite at the Company’s offices, clinical trial sites, and contract service provider facilities, as needed.
Maintain respectful, inclusive, and effective cross-functional communications, collaborating with internal and external stakeholders on strategy and implementation of quality principles and regulatory requirements while remaining independent.
Support short- and long-term objectives for the GLP/GCP functions in accordance with overall Company and Quality strategies.
Act in accordance with Company policies, including for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Other duties as assigned.